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The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04450043
Recruitment Status : Active, not recruiting
First Posted : June 29, 2020
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Lara Traeger, Massachusetts General Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Small-cell Lung Cancer Mesothelioma Cognitive Behavioral Therapy Behavioral: Run-In Sessions 1-5 Behavioral: RCT Transitions Program Sessions 1-5 Behavioral: RCT Control Session Not Applicable

Detailed Description:

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance
Actual Study Start Date : August 1, 2020
Actual Primary Completion Date : January 4, 2022
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Run In
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.
 Behavioral: Run-In Sessions 1-5
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.
Experimental: Intervention
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.
 Behavioral: RCT Transitions Program Sessions 1-5
Sessions 1-5 focuses on learning and practicing skills to enhance post-treatment quality of life.
Active Comparator: Control
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.
 Behavioral: RCT Control Session
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants enrolled [ Time Frame: 12 Weeks ]
    Feasibility will be assessed by calculating the proportions of potential participants enrolled (≥35%)

  2. Number of participants retained [ Time Frame: 12 Weeks ]
    Feasibility will be assessed by calculating the proportions of potential participants retained (≥70%)

  3. Proportion of intervention arm participants who complete study visits [ Time Frame: 12 weeks ]
    Feasibility will be assessed by calculating the proportion of intervention arm participants who complete study visits (≥70% attending ≥60% of sessions)


Secondary Outcome Measures :
  1. Acceptability of study [ Time Frame: Week 12 ]
    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)

  2. Change in Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L) score [ Time Frame: pre-baseline to 12 weeks ]
    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.

  3. Change in Fear of Cancer Recurrence Scale 7 score [ Time Frame: pre-baseline to 12 weeks ]
    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.

  4. Change in Hospital Anxiety and Depression Scale score [ Time Frame: pre-baseline to 12 weeks ]
    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.

  5. Change in Multidimensional Scale of Perceived Social Support score [ Time Frame: pre-baseline to 12 Weeks ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 21 or older
  • Diagnosis of non-small cell (NSCLC) or small cell (SCLC) lung cancer or mesothelioma
  • Documented treatment plan with curative intent
  • Ability to read and respond in English
  • Treatment completion eligibility:

Run-in: Has completed treatment including systemic treatments and radiation as determined within the past three weeks by the cancer care team at Massachusetts General Hospital.

RCT: Has completed treatment including systemic treatments +/- radiation and +/- surgery.

  1. If final treatment is systemic therapy +/- radiation: within three weeks after cancer care team determination that treatment is complete.
  2. If final treatment is surgery: within three weeks after hospital discharge following surgery.

Exclusion Criteria:

  • Comorbid health condition that would interfere with study participation
  • Current participation in cognitive behavioral therapy treatment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450043


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Lara Traeger, Ph.D Massachusetts General Hospital
More Information
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Responsible Party: Lara Traeger, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04450043    
Other Study ID Numbers: 20-140
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lara Traeger, Massachusetts General Hospital:
Non Small Cell Lung Cancer
Small-cell Lung Cancer
Mesothelioma
Cognitive Behavioral Therapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Mesothelioma
Mesothelioma, Malignant
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Pleural Neoplasms