<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/NCT04450043</url>
  </required_header>
  <id_info>
    <org_study_id>20-140</org_study_id>
    <nct_id>NCT04450043</nct_id>
  </id_info>
  <brief_title>The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance</brief_title>
  <official_title>The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</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 research study is designed to develop and test a new supportive care program to help&#xD;
      individuals with lung cancer improve their quality of life after cancer treatment is over.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aims of this pilot study are to evaluate the feasibility and acceptability of a brief&#xD;
      psychoeducational intervention for participants with cancer who are transitioning from active&#xD;
      treatment to surveillance.&#xD;
&#xD;
      The research study procedures include screening for eligibility.&#xD;
&#xD;
      This study consists of 2 parts. It is expected that about 45 people will take part in this&#xD;
      research study.&#xD;
&#xD;
        -  In the first part of this study, about 5 participants will complete survey questions and&#xD;
           receive a 5-session program.&#xD;
&#xD;
        -  In the second part of this study, about 40 participants will complete 3 surveys, and&#xD;
           then will be randomly assigned to receive the 5-session program or to receive one study&#xD;
           session (control).&#xD;
&#xD;
        -  These sessions will focus on providing targeted support related to life after cancer&#xD;
           treatment. The sessions will focus on skills for coping with uncertainty, managing&#xD;
           symptoms, improving social support, and other topics important to the individual.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">November 1, 2023</completion_date>
  <primary_completion_date type="Actual">January 4, 2022</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants enrolled</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Feasibility will be assessed by calculating the proportions of potential participants enrolled (≥35%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants retained</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Feasibility will be assessed by calculating the proportions of potential participants retained (≥70%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of intervention arm participants who complete study visits</measure>
    <time_frame>12 weeks</time_frame>
    <description>Feasibility will be assessed by calculating the proportion of intervention arm participants who complete study visits (≥70% attending ≥60% of sessions)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability of study</measure>
    <time_frame>Week 12</time_frame>
    <description>Participant concerns and recommendations will be used to guide the next trial with respect to intervention content and delivery. Participant responses to the exit interview will be summarized (descriptive statistics for quantitative items) and coded (content analysis for open-ended items)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L) score</measure>
    <time_frame>pre-baseline to 12 weeks</time_frame>
    <description>This measure assesses multidimensional quality of life including physical well-being, social/family well-being, emotional well-being, functional well-being, and lung cancer-specific concerns. Each item is answered on a scale of 0 (not at all) to 5 (very much). Total scores will be used, with higher scores indicating better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fear of Cancer Recurrence Scale 7 score</measure>
    <time_frame>pre-baseline to 12 weeks</time_frame>
    <description>This measure assesses worry about the return of disease with 6 items measured on a 5-point scale and 1 item measured on a 10-point scale. Total scores will be used, with higher scores indicating greater fear of recurrence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hospital Anxiety and Depression Scale score</measure>
    <time_frame>pre-baseline to 12 weeks</time_frame>
    <description>This measure assesses depression and anxiety symptoms (7 items each), and mixed affect (all 14 items). Total scores will be used, with higher scores indicating greater distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Multidimensional Scale of Perceived Social Support score</measure>
    <time_frame>pre-baseline to 12 Weeks</time_frame>
    <description>This measure assesses social support using 12 items on a 7-point Likert-type scale. Mean scores will be used, with higher scores indicating greater perceived support.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <condition>Small-cell Lung Cancer</condition>
  <condition>Mesothelioma</condition>
  <condition>Cognitive Behavioral Therapy</condition>
  <arm_group>
    <arm_group_label>Run In</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a 5-session psychoeducational intervention, focused on skills to enhance post-treatment quality of life with attention to (a) managing expectations, (b) coping with uncertainty, (c) self-managing residual symptoms and (d) strengthening social support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a 5-session psychoeducational intervention, focused on skills to enhance post-treatment quality of life with attention to (a) managing expectations, (b) coping with uncertainty, (c) self-managing residual symptoms and (d) strengthening social support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive a 1-session intervention, focused on reviewing goal progress for post-treatment quality of life, providing encouragement and support, identifying any current concerns, and providing tailored recommendations and resources.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Run-In Sessions 1-5</intervention_name>
    <description>Session 1 explores patient goals and wishes for life after cancer treatment with a study interventionist. Sessions 2-5 focuses on learning and practicing skills to enhance post-treatment quality of life.</description>
    <arm_group_label>Run In</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>RCT Transitions Program Sessions 1-5</intervention_name>
    <description>Sessions 1-5 focuses on learning and practicing skills to enhance post-treatment quality of life.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>RCT Control Session</intervention_name>
    <description>Participants will receive a 1-session intervention, focused on reviewing goal progress for post-treatment quality of life, providing encouragement and support, identifying any current concerns, and providing tailored recommendations and resources.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21 or older&#xD;
&#xD;
          -  Diagnosis of non-small cell (NSCLC) or small cell (SCLC) lung cancer or mesothelioma&#xD;
&#xD;
          -  Documented treatment plan with curative intent&#xD;
&#xD;
          -  Ability to read and respond in English&#xD;
&#xD;
          -  Treatment completion eligibility:&#xD;
&#xD;
        Run-in: Has completed treatment including systemic treatments and radiation as determined&#xD;
        within the past three weeks by the cancer care team at Massachusetts General Hospital.&#xD;
&#xD;
        RCT: Has completed treatment including systemic treatments +/- radiation and +/- surgery.&#xD;
&#xD;
          1. If final treatment is systemic therapy +/- radiation: within three weeks after cancer&#xD;
             care team determination that treatment is complete.&#xD;
&#xD;
          2. If final treatment is surgery: within three weeks after hospital discharge following&#xD;
             surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Comorbid health condition that would interfere with study participation&#xD;
&#xD;
          -  Current participation in cognitive behavioral therapy treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lara Traeger, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>January 11, 2022</last_update_submitted>
  <last_update_submitted_qc>January 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Lara Traeger</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Non Small Cell Lung Cancer</keyword>
  <keyword>Small-cell Lung Cancer</keyword>
  <keyword>Mesothelioma</keyword>
  <keyword>Cognitive Behavioral Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
    <mesh_term>Mesothelioma</mesh_term>
    <mesh_term>Mesothelioma, Malignant</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication</ipd_time_frame>
    <ipd_access_criteria>Contact the Partners Innovations team at http://www.partners.org/innovation</ipd_access_criteria>
  </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/NCT04450043
org study id: 20-140
nct id: NCT04450043
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This research study is designed to develop and test a new supportive care program to help
      individuals with lung cancer improve their quality of life after cancer treatment is over.
The aims of this pilot study are to evaluate the feasibility and acceptability of a brief
      psychoeducational intervention for participants with cancer who are transitioning from active
      treatment to surveillance.

      The research study procedures include screening for eligibility.

      This study consists of 2 parts. It is expected that about 45 people will take part in this
      research study.

        -  In the first part of this study, about 5 participants will complete survey questions and
           receive a 5-session program.

        -  In the second part of this study, about 40 participants will complete 3 surveys, and
           then will be randomly assigned to receive the 5-session program or to receive one study
           session (control).

        -  These sessions will focus on providing targeted support related to life after cancer
           treatment. The sessions will focus on skills for coping with uncertainty, managing
           symptoms, improving social support, and other topics important to the individual.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of participants enrolled
time frame: 12 Weeks
description: Feasibility will be assessed by calculating the proportions of potential participants enrolled (≥35%)
measure: Number of participants retained
time frame: 12 Weeks
description: Feasibility will be assessed by calculating the proportions of potential participants retained (≥70%)
measure: Proportion of intervention arm participants who complete study visits
time frame: 12 weeks
description: Feasibility will be assessed by calculating the proportion of intervention arm participants who complete study visits (≥70% attending ≥60% of sessions)
measure: Acceptability of study
time frame: Week 12
description: Participant concerns and recommendations will be used to guide the next trial with respect to intervention content and delivery. Participant responses to the exit interview will be summarized (descriptive statistics for quantitative items) and coded (content analysis for open-ended items)
measure: Change in Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L) score
time frame: pre-baseline to 12 weeks
description: This measure assesses multidimensional quality of life including physical well-being, social/family well-being, emotional well-being, functional well-being, and lung cancer-specific concerns. Each item is answered on a scale of 0 (not at all) to 5 (very much). Total scores will be used, with higher scores indicating better quality of life.
measure: Change in Fear of Cancer Recurrence Scale 7 score
time frame: pre-baseline to 12 weeks
description: This measure assesses worry about the return of disease with 6 items measured on a 5-point scale and 1 item measured on a 10-point scale. Total scores will be used, with higher scores indicating greater fear of recurrence.
measure: Change in Hospital Anxiety and Depression Scale score
time frame: pre-baseline to 12 weeks
description: This measure assesses depression and anxiety symptoms (7 items each), and mixed affect (all 14 items). Total scores will be used, with higher scores indicating greater distress.
measure: Change in Multidimensional Scale of Perceived Social Support score
time frame: pre-baseline to 12 Weeks
description: This measure assesses social support using 12 items on a 7-point Likert-type scale. Mean scores will be used, with higher scores indicating greater perceived support.
arm group label: Run In
arm group type: Experimental
description: Participants will receive a 5-session psychoeducational intervention, focused on skills to enhance post-treatment quality of life with attention to (a) managing expectations, (b) coping with uncertainty, (c) self-managing residual symptoms and (d) strengthening social support.
arm group label: Intervention
arm group type: Experimental
description: Participants will receive a 5-session psychoeducational intervention, focused on skills to enhance post-treatment quality of life with attention to (a) managing expectations, (b) coping with uncertainty, (c) self-managing residual symptoms and (d) strengthening social support.
arm group label: Control
arm group type: Active Comparator
description: Participants will receive a 1-session intervention, focused on reviewing goal progress for post-treatment quality of life, providing encouragement and support, identifying any current concerns, and providing tailored recommendations and resources.
intervention type: Behavioral
intervention name: Run-In Sessions 1-5
description: Session 1 explores patient goals and wishes for life after cancer treatment with a study interventionist. Sessions 2-5 focuses on learning and practicing skills to enhance post-treatment quality of life.
arm group label: Run In
intervention type: Behavioral
intervention name: RCT Transitions Program Sessions 1-5
description: Sessions 1-5 focuses on learning and practicing skills to enhance post-treatment quality of life.
arm group label: Intervention
intervention type: Behavioral
intervention name: RCT Control Session
description: Participants will receive a 1-session intervention, focused on reviewing goal progress for post-treatment quality of life, providing encouragement and support, identifying any current concerns, and providing tailored recommendations and resources.
arm group label: Control
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Lara Traeger, Ph.D
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Lara Traeger
investigator title: Principal Investigator
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Small Cell Lung Carcinoma
mesh term: Mesothelioma
mesh term: Mesothelioma, Malignant
sharing ipd: Yes
ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data can be shared no earlier than 1 year following the date of publication
ipd access criteria: Contact the Partners Innovations team at http://www.partners.org/innovation