<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03296566</url>
  </required_header>
  <id_info>
    <org_study_id>H16-03194</org_study_id>
    <nct_id>NCT03296566</nct_id>
  </id_info>
  <brief_title>The SAFE Study: Satisfaction and Adherence to Follow-Up With Colposcopy Exams</brief_title>
  <official_title>The SAFE Study: Satisfaction and Adherence to Follow-Up With Colposcopy Exams</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>British Columbia Cancer Agency</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Women's Health Research Institute of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is intended to improve the patient experience of communication of colposcopy&#xD;
      results and follow-up recommendations to patients. Current practice involves results being&#xD;
      forwarded from the colposcopy clinic to the family or referring physician who then informs&#xD;
      the patient. We are testing an intervention informed by focus groups in which a trained&#xD;
      colposcopy nurse (patient liaison) directly contacts patients with their results and&#xD;
      follow-up recommendations while providing education and support. We will examine whether this&#xD;
      intervention improves patient satisfaction, reduces anxiety, and improves rates of adherence&#xD;
      to follow-up and treatment appointments compared to the current practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cervical cancer is the second most commonly diagnosed cancer and third leading cause of&#xD;
      cancer death in women worldwide. Pre-cancerous cells can be detected with regular Pap smear&#xD;
      screening and diagnosed and treated with colposcopy. This process is limited by patient&#xD;
      adherence to the follow-up and treatment recommendations. Currently at Vancouver General&#xD;
      Hospital (VGH), the largest colposcopy clinic in the province, results are forwarded from the&#xD;
      colposcopy clinic to the family or referring physician who informs patients of results and&#xD;
      recommendations. Inefficiencies or errors in this step may cause patient dissatisfaction,&#xD;
      missed appointments, increased costs, and compromise patient outcomes. The primary objective&#xD;
      of this study is to examine whether having a trained colposcopy nurse directly contact&#xD;
      patients with their results and follow-up recommendations while providing education and&#xD;
      support will improve patient satisfaction and reduce anxiety, with the secondary aim being to&#xD;
      assess the clinical effectiveness of this intervention in improving rates of adherence to&#xD;
      follow-up and treatment appointments and potentially long-term clinical outcomes. The first&#xD;
      phase of the study involves patient focus groups that will be interviewed about what elements&#xD;
      of a patient liaison interaction are most important (separate Ethics submission). This&#xD;
      information will inform the development of the patient liaison role and approaches to patient&#xD;
      interaction to be utilized in the intervention in the second phase. The second phase will&#xD;
      entail a randomized controlled trial comparing patient anxiety, satisfaction and adherence to&#xD;
      follow-up between a control group (current practice) versus the intervention group exposed to&#xD;
      the patient liaison at the VGH Colposcopy Clinic. For the primary aim, a questionnaire&#xD;
      containing items pertaining to patient anxiety and satisfaction with their experience of&#xD;
      receiving their colposcopy results will be administered both to the intervention and control&#xD;
      groups and the mean scores pertaining to anxiety and satisfaction will be compared using&#xD;
      two-tailed t-tests. For the secondary aim, a chart review at 6-12 months following the&#xD;
      initial colposcopy visit will examine the rates of compliance with the recommended follow-up&#xD;
      or treatment visits and histologic diagnoses, and comparisons will be sought between the&#xD;
      intervention and control groups using z-score test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>To be collected by questionnaire in 4-6 weeks following colposcopy visit</time_frame>
    <description>Mean state anxiety scores as measured by the State Trait Anxiety Inventory (STAI) State Subscale. The STAI has 40 items with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings from 1-4 &quot;at this moment&quot;: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Item scores are added to obtain subtest total scores and for anxiety-present items, a higher score suggests higher anxiety. Scoring is reversed for anxiety-absent items (items in which a higher score suggests lower anxiety). Range of scores for the subscale is 20-80 with a higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantitative Satisfaction With Colposcopy Visit Experience Including Interactions With Colposcopy Professionals</measure>
    <time_frame>To be collected by questionnaire in 4-6 weeks following colposcopy visit</time_frame>
    <description>Patient satisfaction scores as measured by items in the questionnaire drawn from the Visit Specific Satisfaction Instrument (VSQ-9) Inventory. The VSQ-9 is a 9 item survey that measures patient satisfaction with access to primary care, with the direct interaction with the physician, and with the visit overall on a scale ranging from 1 (poor) to 5 (excellent). To score the VSQ-9, responses from each individual are transformed linearly to a 0 to 100 scale, with 100 corresponding to &quot;excellent&quot; and 0 corresponding to &quot;poor&quot; (0= Poor, 25= Fair, 50= Good, 75= Very Good, 100= Excellent). The 9 responses are then averaged together to create a VSQ-9 overall score for each person, again with 100 being the best evaluation and 0 the poorest.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction With Colposcopy Information and Diagnosis Education</measure>
    <time_frame>To be collected by questionnaire in 4-6 weeks following colposcopy visit</time_frame>
    <description>Satisfaction with information and education received regarding colposcopy, patient diagnosis and follow-up recommendations measured by questionnaire items that measure these factors (PSQ-18 Inventory). This inventory contains 18 items assessing each of the 7 dimensions of satisfaction with medical care (general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, accessibility and convenience). Each item is scored from 1-5. Some PSQ-18 items are worded so that agreement reflects satisfaction with medical care, whereas other items are worded so that agreement reflects dissatisfaction with medical care. All items all scored so that high scores reflect satisfaction with medical care. All items are then summed; sum score of all items may range from 18 to 90 points, where 18 points is the poorest evaluation and 90 points the best.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Knowledge of Own Colposcopy Diagnosis</measure>
    <time_frame>To be collected by questionnaire in 4-6 weeks following colposcopy visit</time_frame>
    <description>The percent of patients who correctly report their colposcopy pathologic diagnosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to Colposcopy Treatment and Follow-up Instructions</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage of patients who attended follow-up at the colposcopy clinic</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">297</enrollment>
  <condition>Uterine Cervical Dysplasia</condition>
  <condition>Uterine Cervix Cancer</condition>
  <arm_group>
    <arm_group_label>Patient Liaison Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants randomized to the intervention group will be exposed to the patient liaison in receiving their colposcopy report results and recommendations. Rather than receive results from their referring/family physician, an experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive the standard of care for colposcopy results reporting via their referring physician. Following their colposcopy visit, control patients are given a slip of paper reminding them to call their family/referring physician for their colposcopy results in three weeks if they have not yet been contacted. Upon receipt of the final pathology, colposcopy reports are prepared by the colposcopists and forwarded to family/referring physicians typically within 2-3 weeks of the visit. Patients then receive the results of their colposcopy report from their family/referring physician by whatever method of communication preferred by that provider.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient Liaison</intervention_name>
    <description>An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist who may then provide answers to the patient liaison or to the patient directly depending on the complexity and nature of the question.</description>
    <arm_group_label>Patient Liaison Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Must be 19 years of age or older&#xD;
&#xD;
          2. Must be patients presenting for an initial visit at the VGH Colposcopy Clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to speak conversational English- required to complete the questionnaire as&#xD;
             well as provide informed consent to participate&#xD;
&#xD;
          2. Inability or refusal to provide consent&#xD;
&#xD;
          3. Pregnant - pregnant women do not usually have biopsies and their subsequent care may&#xD;
             be much different than non-pregnant patients&#xD;
&#xD;
          4. Do not have a family physician or referring physician who will provide continuity of&#xD;
             care following colposcopy - these patients do not have the option of getting results&#xD;
             from a family or referring physician, so they would bias results.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marette Lee, MD/MPH/FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vancouver General Hospital - Gordon and Leslie Diamond Health Care Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Balasubramani L, Orbell S, Hagger M, Brown V, Tidy J. Can default rates in colposcopy really be reduced? BJOG. 2008 Feb;115(3):403-8. doi: 10.1111/j.1471-0528.2007.01594.x.</citation>
    <PMID>18190379</PMID>
  </reference>
  <reference>
    <citation>Boone JD, Erickson BK, Huh WK. New insights into cervical cancer screening. J Gynecol Oncol. 2012 Oct;23(4):282-7. doi: 10.3802/jgo.2012.23.4.282. Epub 2012 Sep 19.</citation>
    <PMID>23094132</PMID>
  </reference>
  <reference>
    <citation>Bredart A, Kop JL, Efficace F, Beaudeau A, Brito T, Dolbeault S, Aaronson N; EORTC Quality of Life Group. Quality of care in the oncology outpatient setting from patients' perspective: a systematic review of questionnaires' content and psychometric performance. Psychooncology. 2015 Apr;24(4):382-94. doi: 10.1002/pon.3661. Epub 2014 Sep 5.</citation>
    <PMID>25196048</PMID>
  </reference>
  <reference>
    <citation>Byrom J, Clarke T, Neale J, Dunn PD, Hughes GM, Redman CW, Pitts M. Can pre-colposcopy sessions reduce anxiety at the time of colposcopy? A prospective randomised study. J Obstet Gynaecol. 2002 Jul;22(4):415-20. doi: 10.1080/01443610220141407.</citation>
    <PMID>12521468</PMID>
  </reference>
  <reference>
    <citation>Dietrich AJ, Tobin JN, Cassells A, Robinson CM, Greene MA, Sox CH, Beach ML, DuHamel KN, Younge RG. Telephone care management to improve cancer screening among low-income women: a randomized, controlled trial. Ann Intern Med. 2006 Apr 18;144(8):563-71. doi: 10.7326/0003-4819-144-8-200604180-00006.</citation>
    <PMID>16618953</PMID>
  </reference>
  <reference>
    <citation>Lerman C, Hanjani P, Caputo C, Miller S, Delmoor E, Nolte S, Engstrom P. Telephone counseling improves adherence to colposcopy among lower-income minority women. J Clin Oncol. 1992 Feb;10(2):330-3. doi: 10.1200/JCO.1992.10.2.330.</citation>
    <PMID>1732434</PMID>
  </reference>
  <reference>
    <citation>Litchfield IJ, Bentham LM, Lilford RJ, McManus RJ, Greenfield SM. Patient perspectives on test result communication in primary care: a qualitative study. Br J Gen Pract. 2015 Mar;65(632):e133-40. doi: 10.3399/bjgp15X683929.</citation>
    <PMID>25733434</PMID>
  </reference>
  <reference>
    <citation>Nugent LS, Tamlyn-Leaman K, Isa N, Reardon E, Crumley J. Anxiety and the colposcopy experience. Clin Nurs Res. 1993 Aug;2(3):267-77. doi: 10.1177/105477389300200304.</citation>
    <PMID>8401241</PMID>
  </reference>
  <reference>
    <citation>O'Connor M, Gallagher P, Waller J, Martin CM, O'Leary JJ, Sharp L; Irish Cervical Screening Research Consortium (CERVIVA). Adverse psychological outcomes following colposcopy and related procedures: a systematic review. BJOG. 2016 Jan;123(1):24-38. doi: 10.1111/1471-0528.13462. Epub 2015 Jun 22.</citation>
    <PMID>26099164</PMID>
  </reference>
  <reference>
    <citation>Percac-Lima S, Ashburner JM, Zai AH, Chang Y, Oo SA, Guimaraes E, Atlas SJ. Patient Navigation for Comprehensive Cancer Screening in High-Risk Patients Using a Population-Based Health Information Technology System: A Randomized Clinical Trial. JAMA Intern Med. 2016 Jul 1;176(7):930-7. doi: 10.1001/jamainternmed.2016.0841.</citation>
    <PMID>27273602</PMID>
  </reference>
  <reference>
    <citation>Towler BP, Irwig LM, Shelley JM. The adequacy of management of women with CIN 2 and CIN 3 Pap smear abnormalities. Med J Aust. 1993 Oct 18;159(8):523, 526-8.</citation>
    <PMID>8412951</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <results_first_submitted>May 15, 2019</results_first_submitted>
  <results_first_submitted_qc>April 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 24, 2020</results_first_posted>
  <last_update_submitted>April 10, 2020</last_update_submitted>
  <last_update_submitted_qc>April 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Marette Lee</investigator_full_name>
    <investigator_title>Program Director, BC Provincial Colposcopy Program</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Uterine Cervical Dysplasia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 29, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03296566/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 29, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03296566/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 30, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03296566/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>297 participants were recruited and subsequently randomized. Post-randomization, 3 participants withdrew from the control arm. 294 patients were analyzed in the statistical analysis.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Patient Liaison Intervention</title>
          <description>The participants randomized to the intervention group will be exposed to the patient liaison in receiving their colposcopy report results and recommendations. Rather than receive results from their referring physician, an experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report.&#xD;
Patient Liaison: An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>The control group will receive the standard of care for colposcopy results reporting via their referring physician. Following their colposcopy visit, control patients are given a slip of paper reminding them to call their family/referring physician for their colposcopy results in three weeks if they have not yet been contacted. Upon receipt of the final pathology, colposcopy reports are prepared by the colposcopists and forwarded to family/referring physicians typically within 2-3 weeks of the visit. Patients then receive the results of their colposcopy report from their family/referring physician by whatever method of communication preferred by that provider.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="145"/>
                <participants group_id="P2" count="152"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="126"/>
                <participants group_id="P2" count="103"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="49"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>297 consenting women &gt;18 years old presenting for initial appointment at the study colposcopy clinic were randomized.&#xD;
Although 152 participants were randomized to the control group, 3 withdrew post-randomization and only 149 were included in the analysis (thus, a total of 294 participants were included in the analysis).</population>
      <group_list>
        <group group_id="B1">
          <title>Patient Liaison Intervention</title>
          <description>The participants randomized to the intervention group will be exposed to the patient liaison in receiving their colposcopy report results and recommendations. Rather than receive results from their referring physician, an experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report.&#xD;
Patient Liaison: An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>The control group will receive the standard of care for colposcopy results reporting via their referring physician. Following their colposcopy visit, control patients are given a slip of paper reminding them to call their family/referring physician for their colposcopy results in three weeks if they have not yet been contacted. Upon receipt of the final pathology, colposcopy reports are prepared by the colposcopists and forwarded to family/referring physicians typically within 2-3 weeks of the visit. Patients then receive the results of their colposcopy report from their family/referring physician by whatever method of communication preferred by that provider.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="145"/>
            <count group_id="B2" value="149"/>
            <count group_id="B3" value="294"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33" lower_limit="28" upper_limit="43.5"/>
                    <measurement group_id="B2" value="31" lower_limit="27" upper_limit="44"/>
                    <measurement group_id="B3" value="33" lower_limit="27" upper_limit="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="145"/>
                    <measurement group_id="B2" value="149"/>
                    <measurement group_id="B3" value="294"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="201"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Anxiety</title>
        <description>Mean state anxiety scores as measured by the State Trait Anxiety Inventory (STAI) State Subscale. The STAI has 40 items with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings from 1-4 &quot;at this moment&quot;: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Item scores are added to obtain subtest total scores and for anxiety-present items, a higher score suggests higher anxiety. Scoring is reversed for anxiety-absent items (items in which a higher score suggests lower anxiety). Range of scores for the subscale is 20-80 with a higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale.</description>
        <time_frame>To be collected by questionnaire in 4-6 weeks following colposcopy visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Patient Liaison Intervention</title>
            <description>The participants randomized to the intervention group will be exposed to the patient liaison in receiving their colposcopy report results and recommendations. Rather than receive results from their referring physician, an experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report.&#xD;
Patient Liaison: An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive the standard of care for colposcopy results reporting via their referring physician. Following their colposcopy visit, control patients are given a slip of paper reminding them to call their family/referring physician for their colposcopy results in three weeks if they have not yet been contacted. Upon receipt of the final pathology, colposcopy reports are prepared by the colposcopists and forwarded to family/referring physicians typically within 2-3 weeks of the visit. Patients then receive the results of their colposcopy report from their family/referring physician by whatever method of communication preferred by that provider.</description>
          </group>
        </group_list>
        <measure>
          <title>Anxiety</title>
          <description>Mean state anxiety scores as measured by the State Trait Anxiety Inventory (STAI) State Subscale. The STAI has 40 items with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings from 1-4 &quot;at this moment&quot;: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Item scores are added to obtain subtest total scores and for anxiety-present items, a higher score suggests higher anxiety. Scoring is reversed for anxiety-absent items (items in which a higher score suggests lower anxiety). Range of scores for the subscale is 20-80 with a higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.3" spread="12.8"/>
                    <measurement group_id="O2" value="40.7" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Quantitative Satisfaction With Colposcopy Visit Experience Including Interactions With Colposcopy Professionals</title>
        <description>Patient satisfaction scores as measured by items in the questionnaire drawn from the Visit Specific Satisfaction Instrument (VSQ-9) Inventory. The VSQ-9 is a 9 item survey that measures patient satisfaction with access to primary care, with the direct interaction with the physician, and with the visit overall on a scale ranging from 1 (poor) to 5 (excellent). To score the VSQ-9, responses from each individual are transformed linearly to a 0 to 100 scale, with 100 corresponding to &quot;excellent&quot; and 0 corresponding to &quot;poor&quot; (0= Poor, 25= Fair, 50= Good, 75= Very Good, 100= Excellent). The 9 responses are then averaged together to create a VSQ-9 overall score for each person, again with 100 being the best evaluation and 0 the poorest.</description>
        <time_frame>To be collected by questionnaire in 4-6 weeks following colposcopy visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Patient Liaison Intervention</title>
            <description>The participants randomized to the intervention group will be exposed to the patient liaison in receiving their colposcopy report results and recommendations. Rather than receive results from their referring physician, an experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report.&#xD;
Patient Liaison: An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive the standard of care for colposcopy results reporting via their referring physician. Following their colposcopy visit, control patients are given a slip of paper reminding them to call their family/referring physician for their colposcopy results in three weeks if they have not yet been contacted. Upon receipt of the final pathology, colposcopy reports are prepared by the colposcopists and forwarded to family/referring physicians typically within 2-3 weeks of the visit. Patients then receive the results of their colposcopy report from their family/referring physician by whatever method of communication preferred by that provider.</description>
          </group>
        </group_list>
        <measure>
          <title>Quantitative Satisfaction With Colposcopy Visit Experience Including Interactions With Colposcopy Professionals</title>
          <description>Patient satisfaction scores as measured by items in the questionnaire drawn from the Visit Specific Satisfaction Instrument (VSQ-9) Inventory. The VSQ-9 is a 9 item survey that measures patient satisfaction with access to primary care, with the direct interaction with the physician, and with the visit overall on a scale ranging from 1 (poor) to 5 (excellent). To score the VSQ-9, responses from each individual are transformed linearly to a 0 to 100 scale, with 100 corresponding to &quot;excellent&quot; and 0 corresponding to &quot;poor&quot; (0= Poor, 25= Fair, 50= Good, 75= Very Good, 100= Excellent). The 9 responses are then averaged together to create a VSQ-9 overall score for each person, again with 100 being the best evaluation and 0 the poorest.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.3" spread="19.2"/>
                    <measurement group_id="O2" value="66.6" spread="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Satisfaction With Colposcopy Information and Diagnosis Education</title>
        <description>Satisfaction with information and education received regarding colposcopy, patient diagnosis and follow-up recommendations measured by questionnaire items that measure these factors (PSQ-18 Inventory). This inventory contains 18 items assessing each of the 7 dimensions of satisfaction with medical care (general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, accessibility and convenience). Each item is scored from 1-5. Some PSQ-18 items are worded so that agreement reflects satisfaction with medical care, whereas other items are worded so that agreement reflects dissatisfaction with medical care. All items all scored so that high scores reflect satisfaction with medical care. All items are then summed; sum score of all items may range from 18 to 90 points, where 18 points is the poorest evaluation and 90 points the best.</description>
        <time_frame>To be collected by questionnaire in 4-6 weeks following colposcopy visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Patient Liaison Intervention</title>
            <description>The participants randomized to the intervention group will be exposed to the patient liaison in receiving their colposcopy report results and recommendations. Rather than receive results from their referring physician, an experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report.&#xD;
Patient Liaison: An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive the standard of care for colposcopy results reporting via their referring physician. Following their colposcopy visit, control patients are given a slip of paper reminding them to call their family/referring physician for their colposcopy results in three weeks if they have not yet been contacted. Upon receipt of the final pathology, colposcopy reports are prepared by the colposcopists and forwarded to family/referring physicians typically within 2-3 weeks of the visit. Patients then receive the results of their colposcopy report from their family/referring physician by whatever method of communication preferred by that provider.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Colposcopy Information and Diagnosis Education</title>
          <description>Satisfaction with information and education received regarding colposcopy, patient diagnosis and follow-up recommendations measured by questionnaire items that measure these factors (PSQ-18 Inventory). This inventory contains 18 items assessing each of the 7 dimensions of satisfaction with medical care (general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, accessibility and convenience). Each item is scored from 1-5. Some PSQ-18 items are worded so that agreement reflects satisfaction with medical care, whereas other items are worded so that agreement reflects dissatisfaction with medical care. All items all scored so that high scores reflect satisfaction with medical care. All items are then summed; sum score of all items may range from 18 to 90 points, where 18 points is the poorest evaluation and 90 points the best.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.6" spread="11.4"/>
                    <measurement group_id="O2" value="65.1" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Knowledge of Own Colposcopy Diagnosis</title>
        <description>The percent of patients who correctly report their colposcopy pathologic diagnosis</description>
        <time_frame>To be collected by questionnaire in 4-6 weeks following colposcopy visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Patient Liaison Intervention</title>
            <description>The participants randomized to the intervention group will be exposed to the patient liaison in receiving their colposcopy report results and recommendations. Rather than receive results from their referring physician, an experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report.&#xD;
Patient Liaison: An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive the standard of care for colposcopy results reporting via their referring physician. Following their colposcopy visit, control patients are given a slip of paper reminding them to call their family/referring physician for their colposcopy results in three weeks if they have not yet been contacted. Upon receipt of the final pathology, colposcopy reports are prepared by the colposcopists and forwarded to family/referring physicians typically within 2-3 weeks of the visit. Patients then receive the results of their colposcopy report from their family/referring physician by whatever method of communication preferred by that provider.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Knowledge of Own Colposcopy Diagnosis</title>
          <description>The percent of patients who correctly report their colposcopy pathologic diagnosis</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.3"/>
                    <measurement group_id="O2" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adherence to Colposcopy Treatment and Follow-up Instructions</title>
        <description>Percentage of patients who attended follow-up at the colposcopy clinic</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Patient Liaison Intervention</title>
            <description>The participants randomized to the intervention group will be exposed to the patient liaison in receiving their colposcopy report results and recommendations. Rather than receive results from their referring physician, an experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report.&#xD;
Patient Liaison: An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive the standard of care for colposcopy results reporting via their referring physician. Following their colposcopy visit, control patients are given a slip of paper reminding them to call their family/referring physician for their colposcopy results in three weeks if they have not yet been contacted. Upon receipt of the final pathology, colposcopy reports are prepared by the colposcopists and forwarded to family/referring physicians typically within 2-3 weeks of the visit. Patients then receive the results of their colposcopy report from their family/referring physician by whatever method of communication preferred by that provider.</description>
          </group>
        </group_list>
        <measure>
          <title>Adherence to Colposcopy Treatment and Follow-up Instructions</title>
          <description>Percentage of patients who attended follow-up at the colposcopy clinic</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.4"/>
                    <measurement group_id="O2" value="52.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months following recruitment</time_frame>
      <desc>The intervention is delivery of colposcopy results. The highest risk serious adverse event (with associated mortality risk) would be failure of colposcopy results delivery leading to failure to receive treatment for cervical dysplasia or carcinoma which may lead to a delay or absence of appropriate treatment with associated morbidity or mortality.</desc>
      <group_list>
        <group group_id="E1">
          <title>Patient Liaison Intervention</title>
          <description>The participants randomized to the intervention group will be exposed to the patient liaison in receiving their colposcopy report results and recommendations. Rather than receive results from their referring physician, an experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report.&#xD;
Patient Liaison: An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>The control group will receive the standard of care for colposcopy results reporting via their referring physician. Following their colposcopy visit, control patients are given a slip of paper reminding them to call their family/referring physician for their colposcopy results in three weeks if they have not yet been contacted. Upon receipt of the final pathology, colposcopy reports are prepared by the colposcopists and forwarded to family/referring physicians typically within 2-3 weeks of the visit. Patients then receive the results of their colposcopy report from their family/referring physician by whatever method of communication preferred by that provider.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Small number of subjects analyzed overall, small number of patients completing questionnaire in the control group</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Marette Lee</name_or_title>
      <organization>University of British Columbia</organization>
      <phone>604.875.5608</phone>
      <email>Marette.Lee@vch.ca</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03296566
org study id: H16-03194
nct id: NCT03296566
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is intended to improve the patient experience of communication of colposcopy
      results and follow-up recommendations to patients. Current practice involves results being
      forwarded from the colposcopy clinic to the family or referring physician who then informs
      the patient. We are testing an intervention informed by focus groups in which a trained
      colposcopy nurse (patient liaison) directly contacts patients with their results and
      follow-up recommendations while providing education and support. We will examine whether this
      intervention improves patient satisfaction, reduces anxiety, and improves rates of adherence
      to follow-up and treatment appointments compared to the current practice.
Cervical cancer is the second most commonly diagnosed cancer and third leading cause of
      cancer death in women worldwide. Pre-cancerous cells can be detected with regular Pap smear
      screening and diagnosed and treated with colposcopy. This process is limited by patient
      adherence to the follow-up and treatment recommendations. Currently at Vancouver General
      Hospital (VGH), the largest colposcopy clinic in the province, results are forwarded from the
      colposcopy clinic to the family or referring physician who informs patients of results and
      recommendations. Inefficiencies or errors in this step may cause patient dissatisfaction,
      missed appointments, increased costs, and compromise patient outcomes. The primary objective
      of this study is to examine whether having a trained colposcopy nurse directly contact
      patients with their results and follow-up recommendations while providing education and
      support will improve patient satisfaction and reduce anxiety, with the secondary aim being to
      assess the clinical effectiveness of this intervention in improving rates of adherence to
      follow-up and treatment appointments and potentially long-term clinical outcomes. The first
      phase of the study involves patient focus groups that will be interviewed about what elements
      of a patient liaison interaction are most important (separate Ethics submission). This
      information will inform the development of the patient liaison role and approaches to patient
      interaction to be utilized in the intervention in the second phase. The second phase will
      entail a randomized controlled trial comparing patient anxiety, satisfaction and adherence to
      follow-up between a control group (current practice) versus the intervention group exposed to
      the patient liaison at the VGH Colposcopy Clinic. For the primary aim, a questionnaire
      containing items pertaining to patient anxiety and satisfaction with their experience of
      receiving their colposcopy results will be administered both to the intervention and control
      groups and the mean scores pertaining to anxiety and satisfaction will be compared using
      two-tailed t-tests. For the secondary aim, a chart review at 6-12 months following the
      initial colposcopy visit will examine the rates of compliance with the recommended follow-up
      or treatment visits and histologic diagnoses, and comparisons will be sought between the
      intervention and control groups using z-score test.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Anxiety
time frame: To be collected by questionnaire in 4-6 weeks following colposcopy visit
description: Mean state anxiety scores as measured by the State Trait Anxiety Inventory (STAI) State Subscale. The STAI has 40 items with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings from 1-4 "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Item scores are added to obtain subtest total scores and for anxiety-present items, a higher score suggests higher anxiety. Scoring is reversed for anxiety-absent items (items in which a higher score suggests lower anxiety). Range of scores for the subscale is 20-80 with a higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale.
measure: Quantitative Satisfaction With Colposcopy Visit Experience Including Interactions With Colposcopy Professionals
time frame: To be collected by questionnaire in 4-6 weeks following colposcopy visit
description: Patient satisfaction scores as measured by items in the questionnaire drawn from the Visit Specific Satisfaction Instrument (VSQ-9) Inventory. The VSQ-9 is a 9 item survey that measures patient satisfaction with access to primary care, with the direct interaction with the physician, and with the visit overall on a scale ranging from 1 (poor) to 5 (excellent). To score the VSQ-9, responses from each individual are transformed linearly to a 0 to 100 scale, with 100 corresponding to "excellent" and 0 corresponding to "poor" (0= Poor, 25= Fair, 50= Good, 75= Very Good, 100= Excellent). The 9 responses are then averaged together to create a VSQ-9 overall score for each person, again with 100 being the best evaluation and 0 the poorest.
measure: Satisfaction With Colposcopy Information and Diagnosis Education
time frame: To be collected by questionnaire in 4-6 weeks following colposcopy visit
description: Satisfaction with information and education received regarding colposcopy, patient diagnosis and follow-up recommendations measured by questionnaire items that measure these factors (PSQ-18 Inventory). This inventory contains 18 items assessing each of the 7 dimensions of satisfaction with medical care (general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, accessibility and convenience). Each item is scored from 1-5. Some PSQ-18 items are worded so that agreement reflects satisfaction with medical care, whereas other items are worded so that agreement reflects dissatisfaction with medical care. All items all scored so that high scores reflect satisfaction with medical care. All items are then summed; sum score of all items may range from 18 to 90 points, where 18 points is the poorest evaluation and 90 points the best.
measure: Patient Knowledge of Own Colposcopy Diagnosis
time frame: To be collected by questionnaire in 4-6 weeks following colposcopy visit
description: The percent of patients who correctly report their colposcopy pathologic diagnosis
measure: Adherence to Colposcopy Treatment and Follow-up Instructions
time frame: 6 months
description: Percentage of patients who attended follow-up at the colposcopy clinic
arm group label: Patient Liaison Intervention
arm group type: Experimental
description: The participants randomized to the intervention group will be exposed to the patient liaison in receiving their colposcopy report results and recommendations. Rather than receive results from their referring/family physician, an experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients.
arm group label: Control
arm group type: No Intervention
description: The control group will receive the standard of care for colposcopy results reporting via their referring physician. Following their colposcopy visit, control patients are given a slip of paper reminding them to call their family/referring physician for their colposcopy results in three weeks if they have not yet been contacted. Upon receipt of the final pathology, colposcopy reports are prepared by the colposcopists and forwarded to family/referring physicians typically within 2-3 weeks of the visit. Patients then receive the results of their colposcopy report from their family/referring physician by whatever method of communication preferred by that provider.
intervention type: Behavioral
intervention name: Patient Liaison
description: An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist who may then provide answers to the patient liaison or to the patient directly depending on the complexity and nature of the question.
arm group label: Patient Liaison Intervention
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Marette Lee, MD/MPH/FRCSC
role: Principal Investigator
affiliation: University of British Columbia
facility: 
country: Canada
citation: Balasubramani L, Orbell S, Hagger M, Brown V, Tidy J. Can default rates in colposcopy really be reduced? BJOG. 2008 Feb;115(3):403-8. doi: 10.1111/j.1471-0528.2007.01594.x.
PMID: 18190379
citation: Boone JD, Erickson BK, Huh WK. New insights into cervical cancer screening. J Gynecol Oncol. 2012 Oct;23(4):282-7. doi: 10.3802/jgo.2012.23.4.282. Epub 2012 Sep 19.
PMID: 23094132
citation: Bredart A, Kop JL, Efficace F, Beaudeau A, Brito T, Dolbeault S, Aaronson N; EORTC Quality of Life Group. Quality of care in the oncology outpatient setting from patients' perspective: a systematic review of questionnaires' content and psychometric performance. Psychooncology. 2015 Apr;24(4):382-94. doi: 10.1002/pon.3661. Epub 2014 Sep 5.
PMID: 25196048
citation: Byrom J, Clarke T, Neale J, Dunn PD, Hughes GM, Redman CW, Pitts M. Can pre-colposcopy sessions reduce anxiety at the time of colposcopy? A prospective randomised study. J Obstet Gynaecol. 2002 Jul;22(4):415-20. doi: 10.1080/01443610220141407.
PMID: 12521468
citation: Dietrich AJ, Tobin JN, Cassells A, Robinson CM, Greene MA, Sox CH, Beach ML, DuHamel KN, Younge RG. Telephone care management to improve cancer screening among low-income women: a randomized, controlled trial. Ann Intern Med. 2006 Apr 18;144(8):563-71. doi: 10.7326/0003-4819-144-8-200604180-00006.
PMID: 16618953
citation: Lerman C, Hanjani P, Caputo C, Miller S, Delmoor E, Nolte S, Engstrom P. Telephone counseling improves adherence to colposcopy among lower-income minority women. J Clin Oncol. 1992 Feb;10(2):330-3. doi: 10.1200/JCO.1992.10.2.330.
PMID: 1732434
citation: Litchfield IJ, Bentham LM, Lilford RJ, McManus RJ, Greenfield SM. Patient perspectives on test result communication in primary care: a qualitative study. Br J Gen Pract. 2015 Mar;65(632):e133-40. doi: 10.3399/bjgp15X683929.
PMID: 25733434
citation: Nugent LS, Tamlyn-Leaman K, Isa N, Reardon E, Crumley J. Anxiety and the colposcopy experience. Clin Nurs Res. 1993 Aug;2(3):267-77. doi: 10.1177/105477389300200304.
PMID: 8401241
citation: O'Connor M, Gallagher P, Waller J, Martin CM, O'Leary JJ, Sharp L; Irish Cervical Screening Research Consortium (CERVIVA). Adverse psychological outcomes following colposcopy and related procedures: a systematic review. BJOG. 2016 Jan;123(1):24-38. doi: 10.1111/1471-0528.13462. Epub 2015 Jun 22.
PMID: 26099164
citation: Percac-Lima S, Ashburner JM, Zai AH, Chang Y, Oo SA, Guimaraes E, Atlas SJ. Patient Navigation for Comprehensive Cancer Screening in High-Risk Patients Using a Population-Based Health Information Technology System: A Randomized Clinical Trial. JAMA Intern Med. 2016 Jul 1;176(7):930-7. doi: 10.1001/jamainternmed.2016.0841.
PMID: 27273602
citation: Towler BP, Irwig LM, Shelley JM. The adequacy of management of women with CIN 2 and CIN 3 Pap smear abnormalities. Med J Aust. 1993 Oct 18;159(8):523, 526-8.
PMID: 8412951
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Marette Lee
investigator title: Program Director, BC Provincial Colposcopy Program
mesh term: Uterine Cervical Neoplasms
mesh term: Uterine Cervical Dysplasia
sharing ipd: No
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Small number of subjects analyzed overall, small number of patients completing questionnaire in the control group
point of contact: 