<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/NCT04465253</url>
  </required_header>
  <id_info>
    <org_study_id>18549</org_study_id>
    <secondary_id>NCI-2020-03475</secondary_id>
    <secondary_id>18549</secondary_id>
    <secondary_id>P30CA033572</secondary_id>
    <nct_id>NCT04465253</nct_id>
  </id_info>
  <brief_title>Remotivation Process for Improving Adherence to Lymphedema Treatment Programs in Patients With Breast Cancer-Related Lymphedema</brief_title>
  <official_title>The Use of the Remotivation Process in an Occupational Therapy Program for Breast Cancer-Related Lymphedema: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>City of Hope Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>City of Hope Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial studies how well the Remotivation Process in an occupational therapy program works&#xD;
      in improving adherence to lymphedema treatment programs in patients with breast&#xD;
      cancer-related lymphedema. Lymphedema treatment programs are well developed and effective,&#xD;
      but adherence to these programs are an issue. The Remotivation Process is a series of&#xD;
      techniques that helps guide discussions between occupational therapists and their patients&#xD;
      based on their level of motivation. This study uses the Remotivation Process by gathering&#xD;
      patients' thoughts about their experience with lymphedema and occupational therapy services&#xD;
      to determine their motivation and learn about the barriers they face in order to improve&#xD;
      adherence to these programs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. How does remotivation process change daily performance of the lymphedema management&#xD;
      techniques? (Quantitative Study) II. How does the Remotivation Process affect the client's&#xD;
      manifestation of breast cancer-related lymphedema (BCRL)? (Quantitative Study) III. How does&#xD;
      the Remotivation Process affect the client's occupational participation and quality of life?&#xD;
      (Quantitative Study) IV. What are the perspectives of patients with BCRL about the&#xD;
      self-management program after participating in an occupational therapy using the Remotivation&#xD;
      Process? (Qualitative Study) V. What are the perspectives of patients with BCRL about their&#xD;
      arm after the occupational therapy program? (Qualitative Study) VI. How do patients with BCRL&#xD;
      describe their daily life after occupational therapy? (Qualitative Study)&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients participate in a discussion with an occupational therapist via videoconferencing&#xD;
      over 15 minutes once weekly (QW) for 4 weeks about their experience with lymphedema and the&#xD;
      occupational services they received. After 4 weeks, some patients may also participate in an&#xD;
      interview with an occupational therapist via videoconferencing over 60 minutes. During the&#xD;
      first week of the study, patients also receive occupational therapy per standard of care.&#xD;
&#xD;
      After completion of study, patients are followed up at 1 month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 19, 2019</start_date>
  <completion_date type="Actual">June 21, 2022</completion_date>
  <primary_completion_date type="Actual">June 21, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in daily performance of the lymphedema management techniques</measure>
    <time_frame>Baseline up to 4 weeks</time_frame>
    <description>Will be assessed by frequency count that records the number of times the participant performed the self-management program during the first and fourth week of the study, which is a 7-day period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in arm girth measurement</measure>
    <time_frame>Baseline up to 4 weeks</time_frame>
    <description>Repeated measures analysis of variance will be used to establish significance and compare the pre-test and post-test girth of the affected arm as well as compare the difference between the affected and non-affected arm at pre-test and post-test. Non-parametric tests will be used should the study not meet the assumptions of parametric test. For non-parametric tests in this case, Friedman's analysis of variance will be used to compare girth.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the number of times each patient performed the self-management program</measure>
    <time_frame>Baseline up to 4 weeks</time_frame>
    <description>Will be compared by a paired t-test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>Baseline up to 4 weeks</time_frame>
    <description>Will be measured by the Lymphedema Quality of Life Inventory. Will be compared using paired t-test. Pearson correlation will be used to determine the correlation between the score from the Model of Human Occupation Screening Tool and scores from the Lymphedema Quality of Life Inventory. Non-parametric tests will be used should the study not meet the assumptions of parametric test. For non-parametric tests in this case, Wilcoxon signed-ranks test will be used to compare the pre-test and post test scores. The Spearman's ranks tests will be used to determine the correlation between the score from the Model of Human Occupation Screening Tool and scores from the Lymphedema Quality of Life Inventory. The qualitative phase follows a descriptive phenomenological design. Thematic analysis will be used to analyze data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in occupational performance</measure>
    <time_frame>Baseline up to 4 weeks</time_frame>
    <description>Will be measured by the Model of Human Occupation Screening Tool. Will be compared using paired t-test. Pearson correlation will be used to determine the correlation between the score from the Model of Human Occupation Screening Tool and scores from the Lymphedema Quality of Life Inventory. Non-parametric tests will be used should the study not meet the assumptions of parametric test. For non-parametric tests in this case, Wilcoxon signed-ranks test will be used to compare the pre-test and post test scores. The Spearman's ranks tests will be used to determine the correlation between the score from the Model of Human Occupation Screening Tool and scores from the Lymphedema Quality of Life Inventory. The qualitative phase follows a descriptive phenomenological design. Thematic analysis will be used to analyze data.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Breast Carcinoma</condition>
  <condition>Lymphedema</condition>
  <arm_group>
    <arm_group_label>Health services research (discussion, interview)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients participate in a discussion with an occupational therapist via videoconferencing over 15 minutes QW for 4 weeks about their experience with lymphedema and the occupational services they received. After 4 weeks, some patients may also participate in an interview with an occupational therapist via videoconferencing over 60 minutes. During the first week of the study, patients also receive occupational therapy per standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Best Practice</intervention_name>
    <description>Undergo standard of care occupational therapy</description>
    <arm_group_label>Health services research (discussion, interview)</arm_group_label>
    <other_name>standard of care</other_name>
    <other_name>standard therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational Interviewing</intervention_name>
    <description>Participate in discussions via videoconferencing</description>
    <arm_group_label>Health services research (discussion, interview)</arm_group_label>
    <other_name>MI</other_name>
    <other_name>Motivational Interviewing Intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational Interviewing</intervention_name>
    <description>Participate in interview via videoconferencing</description>
    <arm_group_label>Health services research (discussion, interview)</arm_group_label>
    <other_name>MI</other_name>
    <other_name>Motivational Interviewing Intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Health services research (discussion, interview)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Health services research (discussion, interview)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unilateral upper extremity lymphedema following procedures to address breast cancer,&#xD;
             able to communicate in English and participate in discussion sessions and follow up&#xD;
             for the duration of the study of eight weeks&#xD;
&#xD;
          -  Women will be able to participate in work, household responsibilities, and possible&#xD;
             child-rearing responsibilities. These are necessary components of quality of life and&#xD;
             occupation, which are the primary concepts of interest of the study. The study will&#xD;
             include women with varied levels of functional performance status and life expectancy&#xD;
             as long as they are willing to participate in a 15-minute discussion once a week in&#xD;
             addition to their scheduled occupational therapy sessions at City of Hope (COH)&#xD;
&#xD;
          -  The effects of Remotivation Process on the developing fetus are unknown. For this&#xD;
             reason, women of child-bearing potential and men must agree to use adequate&#xD;
             contraception (hormonal or barrier method of birth control or abstinence) prior to&#xD;
             study entry and for six months following duration of study participation. Should a&#xD;
             woman become pregnant or suspect that she is pregnant while participating on the&#xD;
             trial, she should inform her treating physician immediately&#xD;
&#xD;
          -  All subjects must have the ability to understand and the willingness to sign a written&#xD;
             informed consent&#xD;
&#xD;
          -  The participant should also be receiving occupational therapy services at COH for BCRL&#xD;
             during the first week of the study. The participant can be an on-going patient&#xD;
             receiving customary occupational therapy services, or a new patient who will be seen&#xD;
             for occupational therapy initial evaluation. The study will include patients with BCRL&#xD;
             regardless of any other medical treatment they are receiving in addition to&#xD;
             occupational therapy. Some participants may only need less than 4 weeks of customary&#xD;
             occupational therapy in order to meet their intervention goals. In this case, the&#xD;
             participant will still be asked to return at the end of the fourth week for follow up.&#xD;
             Data obtained from the outcome measures will be included in quantitative analysis. The&#xD;
             participant will also be included in the list of names that will be randomly selected&#xD;
             for the 60-minute interview&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients should not have any uncontrolled illness including ongoing or active&#xD;
             infection such as cellulitis&#xD;
&#xD;
          -  Subjects, who in the opinion of the investigator, may not be able to comply with the&#xD;
             safety monitoring requirements of the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sherry Hite</last_name>
    <role>Principal Investigator</role>
    <affiliation>City of Hope Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Lymphedema</mesh_term>
    <mesh_term>Breast Cancer Lymphedema</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04465253
org study id: 18549
secondary id: NCI-2020-03475
secondary id: 18549
secondary id: P30CA033572
nct id: NCT04465253
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This trial studies how well the Remotivation Process in an occupational therapy program works
      in improving adherence to lymphedema treatment programs in patients with breast
      cancer-related lymphedema. Lymphedema treatment programs are well developed and effective,
      but adherence to these programs are an issue. The Remotivation Process is a series of
      techniques that helps guide discussions between occupational therapists and their patients
      based on their level of motivation. This study uses the Remotivation Process by gathering
      patients' thoughts about their experience with lymphedema and occupational therapy services
      to determine their motivation and learn about the barriers they face in order to improve
      adherence to these programs.
PRIMARY OBJECTIVES:

      I. How does remotivation process change daily performance of the lymphedema management
      techniques? (Quantitative Study) II. How does the Remotivation Process affect the client's
      manifestation of breast cancer-related lymphedema (BCRL)? (Quantitative Study) III. How does
      the Remotivation Process affect the client's occupational participation and quality of life?
      (Quantitative Study) IV. What are the perspectives of patients with BCRL about the
      self-management program after participating in an occupational therapy using the Remotivation
      Process? (Qualitative Study) V. What are the perspectives of patients with BCRL about their
      arm after the occupational therapy program? (Qualitative Study) VI. How do patients with BCRL
      describe their daily life after occupational therapy? (Qualitative Study)

      OUTLINE:

      Patients participate in a discussion with an occupational therapist via videoconferencing
      over 15 minutes once weekly (QW) for 4 weeks about their experience with lymphedema and the
      occupational services they received. After 4 weeks, some patients may also participate in an
      interview with an occupational therapist via videoconferencing over 60 minutes. During the
      first week of the study, patients also receive occupational therapy per standard of care.

      After completion of study, patients are followed up at 1 month.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in daily performance of the lymphedema management techniques
time frame: Baseline up to 4 weeks
description: Will be assessed by frequency count that records the number of times the participant performed the self-management program during the first and fourth week of the study, which is a 7-day period.
measure: Change in arm girth measurement
time frame: Baseline up to 4 weeks
description: Repeated measures analysis of variance will be used to establish significance and compare the pre-test and post-test girth of the affected arm as well as compare the difference between the affected and non-affected arm at pre-test and post-test. Non-parametric tests will be used should the study not meet the assumptions of parametric test. For non-parametric tests in this case, Friedman's analysis of variance will be used to compare girth.
measure: Change in the number of times each patient performed the self-management program
time frame: Baseline up to 4 weeks
description: Will be compared by a paired t-test.
measure: Change in quality of life
time frame: Baseline up to 4 weeks
description: Will be measured by the Lymphedema Quality of Life Inventory. Will be compared using paired t-test. Pearson correlation will be used to determine the correlation between the score from the Model of Human Occupation Screening Tool and scores from the Lymphedema Quality of Life Inventory. Non-parametric tests will be used should the study not meet the assumptions of parametric test. For non-parametric tests in this case, Wilcoxon signed-ranks test will be used to compare the pre-test and post test scores. The Spearman's ranks tests will be used to determine the correlation between the score from the Model of Human Occupation Screening Tool and scores from the Lymphedema Quality of Life Inventory. The qualitative phase follows a descriptive phenomenological design. Thematic analysis will be used to analyze data.
measure: Change in occupational performance
time frame: Baseline up to 4 weeks
description: Will be measured by the Model of Human Occupation Screening Tool. Will be compared using paired t-test. Pearson correlation will be used to determine the correlation between the score from the Model of Human Occupation Screening Tool and scores from the Lymphedema Quality of Life Inventory. Non-parametric tests will be used should the study not meet the assumptions of parametric test. For non-parametric tests in this case, Wilcoxon signed-ranks test will be used to compare the pre-test and post test scores. The Spearman's ranks tests will be used to determine the correlation between the score from the Model of Human Occupation Screening Tool and scores from the Lymphedema Quality of Life Inventory. The qualitative phase follows a descriptive phenomenological design. Thematic analysis will be used to analyze data.
arm group label: Health services research (discussion, interview)
arm group type: Experimental
description: Patients participate in a discussion with an occupational therapist via videoconferencing over 15 minutes QW for 4 weeks about their experience with lymphedema and the occupational services they received. After 4 weeks, some patients may also participate in an interview with an occupational therapist via videoconferencing over 60 minutes. During the first week of the study, patients also receive occupational therapy per standard of care.
intervention type: Other
intervention name: Best Practice
description: Undergo standard of care occupational therapy
arm group label: Health services research (discussion, interview)
other name: standard of care
other name: standard therapy
intervention type: Behavioral
intervention name: Motivational Interviewing
description: Participate in discussions via videoconferencing
arm group label: Health services research (discussion, interview)
other name: MI
other name: Motivational Interviewing Intervention
intervention type: Behavioral
intervention name: Motivational Interviewing
description: Participate in interview via videoconferencing
arm group label: Health services research (discussion, interview)
other name: MI
other name: Motivational Interviewing Intervention
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Health services research (discussion, interview)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Health services research (discussion, interview)
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Sherry Hite
role: Principal Investigator
affiliation: City of Hope Comprehensive Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Lymphedema
mesh term: Breast Cancer Lymphedema