The Transitions Project: Efficacy Trial
Randomized Trial of an Intervention to Enhance Quality of Life in Adults Completing Lung Cancer Treatment With Curative Intent
1 other identifier
interventional
100
1 country
2
Brief Summary
The aim of this study is to evaluate the efficacy of a brief psychoeducational intervention to improve quality of life in patients with lung cancer who are transitioning from active treatment to surveillance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable lung-cancer
Started Sep 2021
Longer than P75 for not_applicable lung-cancer
2 active sites
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
Study Start
First participant enrolled
September 30, 2021
CompletedFirst Submitted
Initial submission to the registry
October 1, 2021
CompletedFirst Posted
Study publicly available on registry
October 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedMarch 30, 2026
March 1, 2026
2.7 years
October 1, 2021
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of life: Functional Assessment of Cancer Therapy-Lung Cancer
We will investigate longitudinal differences in quality of life between study groups (Functional Assessment of Cancer Therapy-Lung Cancer score range 0-144, with higher scores indicating better quality of life)
Up to 12 weeks
Secondary Outcomes (5)
Fear of cancer recurrence: Fear of Cancer Recurrence Scale 7
Up to 12 weeks
Symptom burden: Edmonton Symptom Assessment Scale
Up to 12 weeks
Psychological symptom burden: Hospital Anxiety and Depression Scale
Up to 12 weeks
Social support: Multidimensional Scale of Perceived Social Support
Up to 12 weeks
Social isolaton: Campaign to End Loneliness Measurement Tool
Up to 12 weeks
Study Arms (2)
Intervention: Five Psycho-educational Sessions
EXPERIMENTALApproximately 6 weeks after the patient's cancer treatment is complete, participants in the intervention arm will proceed to receive up to 5 study sessions (approximately weekly, \~50 minutes each) with a trained interventionist focused on psychoeducational topics. This arm was designed to enhance patient skills to address key concerns during the transition from treatment to surveillance, using a cognitive-behavioral approach. Sessions will be based on an intervention manual.
Enhanced Usual Care: One Psycho-educational Session
EXPERIMENTALAt approximately 6 weeks after treatment completion (as defined by our eligibility criteria), control patients will attend one study session (\~50 minutes) with a study clinician. This session is designed to control for patient access and connection to psychosocial resources as recommended in recent work.
Interventions
5 psychoeducational sessions focused on skills for enhancing wellbeing, relationships, social support, and ability to cope with uncertainty
1 session focused on exploring goals and expectations for post-treatment quality of life, including supportive listening; assessment of unmet needs; preferences for support, and tailored referral recommendations
Eligibility Criteria
You may qualify if:
- Age 21 or older
- Able to read and respond in English
- Diagnosis of non-small cell lung cancer or small cell lung cancer
- Documented curative treatment plan including systemic therapy +/- radiation and +/- surgery
- Completed cancer treatment within past 3 weeks
- If final treatment is systemic therapy +/- radiation: within 3 weeks after cancer care team determination that treatment is complete
- If final treatment is surgery: within 3 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
- Massachusetts General Hospitallead
- American Lung Associationcollaborator
Study Sites (2)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lara Traeger, PhD
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
October 1, 2021
First Posted
October 21, 2021
Study Start
September 30, 2021
Primary Completion
June 15, 2024
Study Completion (Estimated)
June 30, 2026
Last Updated
March 30, 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: \[contact information for Sponsor Investigator or designee\]. 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.