The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2020
CompletedFirst Posted
Study publicly available on registry
June 29, 2020
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
ExpectedMarch 27, 2026
March 1, 2026
1.4 years
June 24, 2020
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of participants enrolled
Feasibility will be assessed by calculating the proportions of potential participants enrolled (≥35%)
12 Weeks
Number of participants retained
Feasibility will be assessed by calculating the proportions of potential participants retained (≥70%)
12 Weeks
Proportion of intervention arm participants who complete study visits
Feasibility will be assessed by calculating the proportion of intervention arm participants who complete study visits (≥70% attending ≥60% of sessions)
12 weeks
Secondary Outcomes (5)
Acceptability of study
Week 12
Change in Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L) score
pre-baseline to 12 weeks
Change in Fear of Cancer Recurrence Scale 7 score
pre-baseline to 12 weeks
Change in Hospital Anxiety and Depression Scale score
pre-baseline to 12 weeks
Change in Multidimensional Scale of Perceived Social Support score
pre-baseline to 12 Weeks
Study Arms (3)
Run In
EXPERIMENTALParticipants 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.
Intervention
EXPERIMENTALParticipants 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.
Control
ACTIVE COMPARATORParticipants 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.
Interventions
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.
Sessions 1-5 focuses on learning and practicing skills to enhance post-treatment quality of life.
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.
Eligibility Criteria
You may qualify if:
- 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.
- If final treatment is systemic therapy +/- radiation: within three weeks after cancer care team determination that treatment is complete.
- If final treatment is surgery: within three weeks after hospital discharge following surgery.
You may not qualify if:
- Comorbid health condition that would interfere with study participation
- Current participation in cognitive behavioral therapy treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lara Traeger, Ph.D
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 24, 2020
First Posted
June 29, 2020
Study Start
August 1, 2020
Primary Completion
January 4, 2022
Study Completion (Estimated)
November 1, 2026
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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
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.