<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/NCT03017456</url>
  </required_header>
  <id_info>
    <org_study_id>15-5045-CE</org_study_id>
    <nct_id>NCT03017456</nct_id>
  </id_info>
  <brief_title>PC 360 Survivorship</brief_title>
  <official_title>Prostate Cancer Survivorship 360°</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vancouver Prostate Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>No</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>
      Prostate Cancer Survivorship 360º is a collaboration-based initiative involving prostate&#xD;
      cancer (PC) and survivorship researchers/clinicians from three Canadian prostate centers with&#xD;
      the goal of identifying and tracking unmet supportive care needs of patients with localized&#xD;
      PC and responding to these needs through survivorship care. The current randomized control&#xD;
      trail (RCT) will focus on the development and evaluation of a facilitated electronic Prostate&#xD;
      Cancer Survivorship Care Plan (PC-SCP). The aims of this project are: 1) to develop an&#xD;
      appropriate and tailored SCP and transition care delivery process; and 2) to conduct an RCT&#xD;
      to evaluate whether a personalized PC SCP intervention is more effective than usual care (UC)&#xD;
      on patient activation (primary outcome) and access to services, self-Management support,&#xD;
      satisfaction with information, HRQoL and cancer worry (secondary outcomes). Data from a&#xD;
      multi-site prospective database- Prostate Cancer Survivorship Information System (PC360-IS)&#xD;
      will be used to electronically populate the survivorship care plans. Overall, this proposal&#xD;
      represents initial steps in uniting the country in sharing programmatic resources, data,&#xD;
      expertise, and enthusiasm to transform survivorship care for men with PC and their families.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Phase III RCT will evaluate the superiority of a Survivorship Care Plan (SCP) intervention&#xD;
      (SCP-Int) compared with usual care (UC) after primary curative prostate cancer (PC)&#xD;
      treatment. Each of the three sites has designated clinical study leads (AM, LG, and ST), high&#xD;
      referral volumes and study leads' patients will be entered into the PC360-IS database which&#xD;
      will be interfaced to the PC-SCP system to consolidate patient details and generate&#xD;
      personalized SCPs. Research ethics approval will be obtained at each site. The trial will be&#xD;
      registered with clinicaltrials.gov and reported using the CONSORT recommendations for trials.&#xD;
&#xD;
      The study population inclusion criteria are as follows: Histologically confirmed localized&#xD;
      (T1-T3N0M0) PC; age at diagnosis &gt;18 years; treated with curative intent; treatment received&#xD;
      &gt;1 month and &lt;6 months; disease-free as defined by absence of somatic disease activity&#xD;
      parameters as per oncologist/urologist; consented to participate in the PC360-IS database.&#xD;
      Exclusion Criteria: Patients who do not receive treatment and are followed by active&#xD;
      surveillance; inability to complete study questionnaires.&#xD;
&#xD;
      Eligible patients will be randomly assigned to either the intervention arm or the control&#xD;
      arm. A biostatistician will randomly assign participants to ensure that both the study RA and&#xD;
      the participants are unaware of the treatment (SCP-int)/control groups (UC). Consenting&#xD;
      patients will be registered into the study and randomized to receive either the SCP-Int or&#xD;
      UC. Patients in the SCP-Int arm will be scheduled for the SCP-Int appointment on the same day&#xD;
      as the patient's first (or second) follow-up appointment.&#xD;
&#xD;
      Eligible patients will be sent a study information letter which will be signed by the&#xD;
      patient's urologist/ oncologist one month after the end of primary treatment. The RA will&#xD;
      then contact patients to further explain the study. If agreeable, the patients will be sent&#xD;
      consent forms, two stamped envelopes, and a baseline questionnaire to complete prior to the&#xD;
      scheduled follow-up appointment. The patients will be asked to mail back the signed consent&#xD;
      form and the completed questionnaire in each the envelopes provided.&#xD;
&#xD;
      Participants will have as much time as needed to decide if the participants would like to&#xD;
      participate in the study prior to signing the consent form. The Research Analyst will obtain&#xD;
      consent.&#xD;
&#xD;
      Planned trial interventions: SCP-Int: Patients in the SCP-Int arm will be asked to attend a&#xD;
      one-time appointment with a trained oncology nurse (study nurse). To avoid additional travel&#xD;
      and related costs to the patient, this appointment will be scheduled on the same day as the&#xD;
      patient's follow-up appointment. The SCP-Int is comprised of two components: a 30-minute&#xD;
      nurse-led face-to-face intervention and the provision of a tailored PC-specific SCP (PC-SCP).&#xD;
      The intervention will be developed based on an established person-centred nursing framework&#xD;
      with a tailored approach to customizing the intervention to the individual and will focus on&#xD;
      the provision of self-management education and support and promote access to and coordination&#xD;
      of post-treatment care including appropriate referrals to relevant programs and services&#xD;
      (including TrueNTH solutions). The content of the PC-SCP will provide structure to the&#xD;
      appointment. Persistent effects and concerns that are identified will prompt the development&#xD;
      of a tailored management plan (i.e. patient education, referral to programs and services)&#xD;
      captured within the PC-SCP. Relevant patient education and TrueNTH materials will be linked&#xD;
      electronically. The appointment will focus on empowering the PC survivor to actively&#xD;
      self-manage persistent treatment effects and to decrease the patients' risk of late effects&#xD;
      by providing effective health information, support, and self-management support. Nurses will&#xD;
      integrate a number of &quot;active behaviour change ingredients&quot; including the integration of&#xD;
      motivational interviewing techniques which are effective in increasing healthy behaviours.&#xD;
      Usual Care (UC): Patients in the UC arm will receive care according to usual practice. This&#xD;
      usually involves a brief office visit (approximately 5-10 minutes) with pertinent history and&#xD;
      physical examination related to surgical/radiation recovery, review of the pathology and&#xD;
      general instructions regarding the next step in follow-up. In addition, patients in the UC&#xD;
      arm will be able to access any supportive care programs or service available at the hospital&#xD;
      according to usual practice. Currently, SCPs and dedicated transition appointments are not&#xD;
      provided as part of a standard of care.&#xD;
&#xD;
      Allocation to trial groups: Patients will be allocated to either SCP-Int or UC by the&#xD;
      Department of Biostatistics at Princess Margaret using a computer-generated randomization&#xD;
      process (random blocks known only to statisticians). The research coordinator will telephone&#xD;
      Biostatistics staff, who will not be involved in recruitment, to obtain the subject's&#xD;
      assignment. Eligible patients from each site will be approached until the target number of&#xD;
      participants is reached (or until a decision is made to stop recruitment).&#xD;
&#xD;
      Data collection: Data will be collected and analyzed according to the outlined project aims.&#xD;
      Based on CONSORT criteria, a screening log will enable data collection on eligible and&#xD;
      non-recruited patients with reasons for non-recruitment recorded when known. All data will be&#xD;
      entered into a secured, password protected database within the UHN server. A separate&#xD;
      database will be used for participant tracking to prevent re-approaching patients&#xD;
      unnecessarily, and to ensure patients are receiving the questionnaire packages according to&#xD;
      the study timeline.&#xD;
&#xD;
      Proposed primary and secondary outcome measures:&#xD;
&#xD;
      The outcome measures were chosen based on recent consensus and recommendations on the&#xD;
      evaluation of SCPs. Patients will be assessed at baseline (T0), 6 (T1), and 12 (T2) months&#xD;
      post-treatment. This questionnaire package is estimated to take 45 minutes to complete.&#xD;
&#xD;
      Primary Outcome: Patient activation will be measured using the Patient Activation Measure&#xD;
      (PAM-13), a 13-items measure assessing knowledge, skills, beliefs, and confidence in managing&#xD;
      health and health care. Patient activation is strongly related to a broad range of&#xD;
      health-related outcomes. The primary outcome will be the overall score of the 13 items&#xD;
      collected at T2.&#xD;
&#xD;
      Secondary Outcomes: a) Supportive care services utilization: using the Health and Social&#xD;
      Services Utilization Inventory (HSSUI) modified for use in cancer populations. Service types&#xD;
      are grouped into five categories: Health Professionals, Institutional/Hospital Programs;&#xD;
      Nursing and Homemaker Support Programs; Other Community and Social Support Program/Resources&#xD;
      (will include True NTH solutions); Programs/Resources.; b) Self-Management Support will be&#xD;
      assessed using the Health Education Impact Questionnaire (heiQ), designed to evaluate&#xD;
      outcomes from patient education and self-management interventions for people with chronic&#xD;
      conditions; c) Satisfaction with Information will be measured with the 25-item European&#xD;
      Organisation for Research and Treatment of Cancer Quality of Life INFO25 module which&#xD;
      evaluates satisfaction with information received by cancer patients; d) Quality of Life will&#xD;
      be measured using the Expanded Prostate Cancer Index Composite (EPIC) which assesses&#xD;
      PC-specific quality of life, and e) Cancer Worry will be measured using the Assessment of&#xD;
      Survivors Concerns (ASC) measure which assesses fear of recurrence and health in cancer&#xD;
      survivors.&#xD;
&#xD;
      Proposed sample size and justification: Our sample size calculations are based on 85% power&#xD;
      with an alpha-level of 0.05, a standard deviation of 16 and a difference between groups of 8&#xD;
      points on the primary outcome (or half a standard deviation difference). Given these&#xD;
      specifications, the required sample size is 146 patients (or 73 patients per arm). Assuming&#xD;
      attrition of up to 20%, 180 patients will be recruited (or 90 patients per arm). Based on&#xD;
      previous studies, we expect to enroll about 70% of eligible patients. The number of&#xD;
      potentially eligible patients from participating sites is estimated to vary between 15-30&#xD;
      patients per month. Based on these estimates and our anticipated participation rates, we&#xD;
      anticipate recruiting 20 patients per month with total recruitment completed within 9 months.&#xD;
      We anticipate at least 80% will complete the 12-month post-treatment follow-up. We will use&#xD;
      multiple strategies to promote retention and prevent attrition. Reasons for participant&#xD;
      attrition will be documented.&#xD;
&#xD;
      Proposed analyses: Analyses will be performed adhering to the intention to treat principle.&#xD;
      Descriptive statistics will be used to summarize baseline demographic and clinical&#xD;
      characteristics of participants in both groups. Recruitment bias and possible differential&#xD;
      attrition will be assessed by calculating the standardized differences between the two arms.&#xD;
      The overall PAM-13 score at 12 months adjusted for the baseline score will be compared&#xD;
      between the two arms using the t-test if the data appears normal or the Mann-Whitney test&#xD;
      otherwise. A p-value&lt;=0.05 will be deemed significant. Secondary analyses of all scores at&#xD;
      each time point will be conducted utilizing the mixed effect modeling to account for the&#xD;
      intra-patient and intra-centre dependency due to the repeated measures within a patient and&#xD;
      the multi-centre design. The residuals will be inspected and data will be transformed when&#xD;
      necessary. Due to multiple testing for the secondary analyses a Hochberg-Benjamini approach&#xD;
      will be used to ensure that the type I error rate does not exceed 0.05.&#xD;
&#xD;
      Cost-utility analyses: The analysis will also include a trial-based cost utility analysis.&#xD;
      The health utility measured using the PORPUS-U and EQ-5D instruments will be used to provide&#xD;
      patient-specific and group-mean estimates of quality-adjusted survival (Quality Adjusted Life&#xD;
      Years). Costs from the payer perspective and from the societal perspective will be gathered&#xD;
      using the HSSUI and an estimate of intervention costs. Inverse probability weighting will be&#xD;
      used to adjust for induced dependent censoring. A net benefit regression approach will be&#xD;
      employed to explore predictors of cost-effectiveness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 29, 2017</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</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>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in the Patient Activation measure questionnaire</measure>
    <time_frame>Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in the Health and Social Services Utilization Inventory</measure>
    <time_frame>change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Health Education Impact Questionnaire</measure>
    <time_frame>Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Quality of Life INFO25 module</measure>
    <time_frame>Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Expanded Prostate Cancer Index Composite</measure>
    <time_frame>Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Assessment of Survivors Concerns measure</measure>
    <time_frame>baseline (prior to intervention), 6 months post intervention, 12 months post intervention.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">203</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Usual Care (UC)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the UC arm will not receive the study intervention (behavioral) and instead will receive care according to usual practice. This usually involves a brief office visit (approximately 5-10 minutes) with pertinent history and physical examination related to surgical/radiation recovery, review of the pathology and general instructions regarding the next step in follow-up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SCP-Intervention vs usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>behavioral intervention vs control Patients in the SCP-Int arm will be asked to attend a one-time appointment with a trained oncology nurse. The SCP-Int is comprised of a 30-minute nurse-led face-to-face intervention and the provision of a tailored PC-specific SCP (PC-SCP). Persistent effects and concerns that are identified will prompt the development of a tailored management plan captured within the PC-SCP. Relevant patient education materials will be linked electronically. Nurses will use motivational interviewing techniques to effective in increase healthy behaviors and empower the PC survivor to actively self-manage persistent treatment effects and to decrease their risk of late effects by providing effective health information, support, and self-management support.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Survivorship Care Plan</intervention_name>
    <description>SCP-Intervention: Patients in the SCP-Int arm will attend a one-time appointment with a trained oncology nurse while the patients in the UC arm will receive care according to the hospital standards for follow-up care. The intervention will be delivered during a regular follow-up appointment, face-to-face and will inform and educate patients on self-management and support as well as promote access to and coordination of post-treatment care. The appointment will focus on empowering the PC survivor to actively self-manage persistent treatment effects and to decrease their risk of late effects by providing effective health information, support, and self-management support. Nurses will integrate a number of &quot;active behavior change ingredients&quot; including the integration of motivational interviewing techniques which are effective in increasing healthy behaviors.</description>
    <arm_group_label>SCP-Intervention vs usual care</arm_group_label>
    <other_name>PC 360-SCP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed localized (T1-T3N0M0) PC&#xD;
&#xD;
          -  age at diagnosis &gt;18 years&#xD;
&#xD;
          -  treated with curative intent&#xD;
&#xD;
          -  treatment received &gt;1 month and &lt;6 months&#xD;
&#xD;
          -  disease-free as defined by absence of somatic disease activity parameters as per&#xD;
             oncologist/urologist&#xD;
&#xD;
          -  consented to participate in the PC360-IS database.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not receive treatment and are followed by active surveillance&#xD;
&#xD;
          -  inability to complete study questionnaires.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer M Jones, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Princess Margaret Cancer Centre, University Health Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vancouver Prostate Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network - Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3H 2R9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>May 7, 2023</last_update_submitted>
  <last_update_submitted_qc>May 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Survivorship</keyword>
  <keyword>Prostate Cancer</keyword>
  <keyword>Survivorship Care Plan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03017456
org study id: 15-5045-CE
nct id: NCT03017456
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prostate Cancer Survivorship 360º is a collaboration-based initiative involving prostate
      cancer (PC) and survivorship researchers/clinicians from three Canadian prostate centers with
      the goal of identifying and tracking unmet supportive care needs of patients with localized
      PC and responding to these needs through survivorship care. The current randomized control
      trail (RCT) will focus on the development and evaluation of a facilitated electronic Prostate
      Cancer Survivorship Care Plan (PC-SCP). The aims of this project are: 1) to develop an
      appropriate and tailored SCP and transition care delivery process; and 2) to conduct an RCT
      to evaluate whether a personalized PC SCP intervention is more effective than usual care (UC)
      on patient activation (primary outcome) and access to services, self-Management support,
      satisfaction with information, HRQoL and cancer worry (secondary outcomes). Data from a
      multi-site prospective database- Prostate Cancer Survivorship Information System (PC360-IS)
      will be used to electronically populate the survivorship care plans. Overall, this proposal
      represents initial steps in uniting the country in sharing programmatic resources, data,
      expertise, and enthusiasm to transform survivorship care for men with PC and their families.
A Phase III RCT will evaluate the superiority of a Survivorship Care Plan (SCP) intervention
      (SCP-Int) compared with usual care (UC) after primary curative prostate cancer (PC)
      treatment. Each of the three sites has designated clinical study leads (AM, LG, and ST), high
      referral volumes and study leads' patients will be entered into the PC360-IS database which
      will be interfaced to the PC-SCP system to consolidate patient details and generate
      personalized SCPs. Research ethics approval will be obtained at each site. The trial will be
      registered with clinicaltrials.gov and reported using the CONSORT recommendations for trials.

      The study population inclusion criteria are as follows: Histologically confirmed localized
      (T1-T3N0M0) PC; age at diagnosis >18 years; treated with curative intent; treatment received
      >1 month and <6 months; disease-free as defined by absence of somatic disease activity
      parameters as per oncologist/urologist; consented to participate in the PC360-IS database.
      Exclusion Criteria: Patients who do not receive treatment and are followed by active
      surveillance; inability to complete study questionnaires.

      Eligible patients will be randomly assigned to either the intervention arm or the control
      arm. A biostatistician will randomly assign participants to ensure that both the study RA and
      the participants are unaware of the treatment (SCP-int)/control groups (UC). Consenting
      patients will be registered into the study and randomized to receive either the SCP-Int or
      UC. Patients in the SCP-Int arm will be scheduled for the SCP-Int appointment on the same day
      as the patient's first (or second) follow-up appointment.

      Eligible patients will be sent a study information letter which will be signed by the
      patient's urologist/ oncologist one month after the end of primary treatment. The RA will
      then contact patients to further explain the study. If agreeable, the patients will be sent
      consent forms, two stamped envelopes, and a baseline questionnaire to complete prior to the
      scheduled follow-up appointment. The patients will be asked to mail back the signed consent
      form and the completed questionnaire in each the envelopes provided.

      Participants will have as much time as needed to decide if the participants would like to
      participate in the study prior to signing the consent form. The Research Analyst will obtain
      consent.

      Planned trial interventions: SCP-Int: Patients in the SCP-Int arm will be asked to attend a
      one-time appointment with a trained oncology nurse (study nurse). To avoid additional travel
      and related costs to the patient, this appointment will be scheduled on the same day as the
      patient's follow-up appointment. The SCP-Int is comprised of two components: a 30-minute
      nurse-led face-to-face intervention and the provision of a tailored PC-specific SCP (PC-SCP).
      The intervention will be developed based on an established person-centred nursing framework
      with a tailored approach to customizing the intervention to the individual and will focus on
      the provision of self-management education and support and promote access to and coordination
      of post-treatment care including appropriate referrals to relevant programs and services
      (including TrueNTH solutions). The content of the PC-SCP will provide structure to the
      appointment. Persistent effects and concerns that are identified will prompt the development
      of a tailored management plan (i.e. patient education, referral to programs and services)
      captured within the PC-SCP. Relevant patient education and TrueNTH materials will be linked
      electronically. The appointment will focus on empowering the PC survivor to actively
      self-manage persistent treatment effects and to decrease the patients' risk of late effects
      by providing effective health information, support, and self-management support. Nurses will
      integrate a number of "active behaviour change ingredients" including the integration of
      motivational interviewing techniques which are effective in increasing healthy behaviours.
      Usual Care (UC): Patients in the UC arm will receive care according to usual practice. This
      usually involves a brief office visit (approximately 5-10 minutes) with pertinent history and
      physical examination related to surgical/radiation recovery, review of the pathology and
      general instructions regarding the next step in follow-up. In addition, patients in the UC
      arm will be able to access any supportive care programs or service available at the hospital
      according to usual practice. Currently, SCPs and dedicated transition appointments are not
      provided as part of a standard of care.

      Allocation to trial groups: Patients will be allocated to either SCP-Int or UC by the
      Department of Biostatistics at Princess Margaret using a computer-generated randomization
      process (random blocks known only to statisticians). The research coordinator will telephone
      Biostatistics staff, who will not be involved in recruitment, to obtain the subject's
      assignment. Eligible patients from each site will be approached until the target number of
      participants is reached (or until a decision is made to stop recruitment).

      Data collection: Data will be collected and analyzed according to the outlined project aims.
      Based on CONSORT criteria, a screening log will enable data collection on eligible and
      non-recruited patients with reasons for non-recruitment recorded when known. All data will be
      entered into a secured, password protected database within the UHN server. A separate
      database will be used for participant tracking to prevent re-approaching patients
      unnecessarily, and to ensure patients are receiving the questionnaire packages according to
      the study timeline.

      Proposed primary and secondary outcome measures:

      The outcome measures were chosen based on recent consensus and recommendations on the
      evaluation of SCPs. Patients will be assessed at baseline (T0), 6 (T1), and 12 (T2) months
      post-treatment. This questionnaire package is estimated to take 45 minutes to complete.

      Primary Outcome: Patient activation will be measured using the Patient Activation Measure
      (PAM-13), a 13-items measure assessing knowledge, skills, beliefs, and confidence in managing
      health and health care. Patient activation is strongly related to a broad range of
      health-related outcomes. The primary outcome will be the overall score of the 13 items
      collected at T2.

      Secondary Outcomes: a) Supportive care services utilization: using the Health and Social
      Services Utilization Inventory (HSSUI) modified for use in cancer populations. Service types
      are grouped into five categories: Health Professionals, Institutional/Hospital Programs;
      Nursing and Homemaker Support Programs; Other Community and Social Support Program/Resources
      (will include True NTH solutions); Programs/Resources.; b) Self-Management Support will be
      assessed using the Health Education Impact Questionnaire (heiQ), designed to evaluate
      outcomes from patient education and self-management interventions for people with chronic
      conditions; c) Satisfaction with Information will be measured with the 25-item European
      Organisation for Research and Treatment of Cancer Quality of Life INFO25 module which
      evaluates satisfaction with information received by cancer patients; d) Quality of Life will
      be measured using the Expanded Prostate Cancer Index Composite (EPIC) which assesses
      PC-specific quality of life, and e) Cancer Worry will be measured using the Assessment of
      Survivors Concerns (ASC) measure which assesses fear of recurrence and health in cancer
      survivors.

      Proposed sample size and justification: Our sample size calculations are based on 85% power
      with an alpha-level of 0.05, a standard deviation of 16 and a difference between groups of 8
      points on the primary outcome (or half a standard deviation difference). Given these
      specifications, the required sample size is 146 patients (or 73 patients per arm). Assuming
      attrition of up to 20%, 180 patients will be recruited (or 90 patients per arm). Based on
      previous studies, we expect to enroll about 70% of eligible patients. The number of
      potentially eligible patients from participating sites is estimated to vary between 15-30
      patients per month. Based on these estimates and our anticipated participation rates, we
      anticipate recruiting 20 patients per month with total recruitment completed within 9 months.
      We anticipate at least 80% will complete the 12-month post-treatment follow-up. We will use
      multiple strategies to promote retention and prevent attrition. Reasons for participant
      attrition will be documented.

      Proposed analyses: Analyses will be performed adhering to the intention to treat principle.
      Descriptive statistics will be used to summarize baseline demographic and clinical
      characteristics of participants in both groups. Recruitment bias and possible differential
      attrition will be assessed by calculating the standardized differences between the two arms.
      The overall PAM-13 score at 12 months adjusted for the baseline score will be compared
      between the two arms using the t-test if the data appears normal or the Mann-Whitney test
      otherwise. A p-value<=0.05 will be deemed significant. Secondary analyses of all scores at
      each time point will be conducted utilizing the mixed effect modeling to account for the
      intra-patient and intra-centre dependency due to the repeated measures within a patient and
      the multi-centre design. The residuals will be inspected and data will be transformed when
      necessary. Due to multiple testing for the secondary analyses a Hochberg-Benjamini approach
      will be used to ensure that the type I error rate does not exceed 0.05.

      Cost-utility analyses: The analysis will also include a trial-based cost utility analysis.
      The health utility measured using the PORPUS-U and EQ-5D instruments will be used to provide
      patient-specific and group-mean estimates of quality-adjusted survival (Quality Adjusted Life
      Years). Costs from the payer perspective and from the societal perspective will be gathered
      using the HSSUI and an estimate of intervention costs. Inverse probability weighting will be
      used to adjust for induced dependent censoring. A net benefit regression approach will be
      employed to explore predictors of cost-effectiveness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Changes in the Patient Activation measure questionnaire
time frame: Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.
measure: Changes in the Health and Social Services Utilization Inventory
time frame: change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.
measure: Changes in the Health Education Impact Questionnaire
time frame: Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.
measure: Changes in the Quality of Life INFO25 module
time frame: Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.
measure: Changes in the Expanded Prostate Cancer Index Composite
time frame: Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.
measure: Changes in the Assessment of Survivors Concerns measure
time frame: baseline (prior to intervention), 6 months post intervention, 12 months post intervention.
arm group label: Usual Care (UC)
arm group type: No Intervention
description: Patients in the UC arm will not receive the study intervention (behavioral) and instead will receive care according to usual practice. This usually involves a brief office visit (approximately 5-10 minutes) with pertinent history and physical examination related to surgical/radiation recovery, review of the pathology and general instructions regarding the next step in follow-up.
arm group label: SCP-Intervention vs usual care
arm group type: Active Comparator
description: behavioral intervention vs control Patients in the SCP-Int arm will be asked to attend a one-time appointment with a trained oncology nurse. The SCP-Int is comprised of a 30-minute nurse-led face-to-face intervention and the provision of a tailored PC-specific SCP (PC-SCP). Persistent effects and concerns that are identified will prompt the development of a tailored management plan captured within the PC-SCP. Relevant patient education materials will be linked electronically. Nurses will use motivational interviewing techniques to effective in increase healthy behaviors and empower the PC survivor to actively self-manage persistent treatment effects and to decrease their risk of late effects by providing effective health information, support, and self-management support.
intervention type: Behavioral
intervention name: Survivorship Care Plan
description: SCP-Intervention: Patients in the SCP-Int arm will attend a one-time appointment with a trained oncology nurse while the patients in the UC arm will receive care according to the hospital standards for follow-up care. The intervention will be delivered during a regular follow-up appointment, face-to-face and will inform and educate patients on self-management and support as well as promote access to and coordination of post-treatment care. The appointment will focus on empowering the PC survivor to actively self-manage persistent treatment effects and to decrease their risk of late effects by providing effective health information, support, and self-management support. Nurses will integrate a number of "active behavior change ingredients" including the integration of motivational interviewing techniques which are effective in increasing healthy behaviors.
arm group label: SCP-Intervention vs usual care
other name: PC 360-SCP
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer M Jones, PhD
role: Principal Investigator
affiliation: Princess Margaret Cancer Centre, University Health Network
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No