The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance
- Conditions
- Small-cell Lung CancerNon Small Cell Lung CancerMesotheliomaCognitive Behavioral Therapy
- Interventions
- Behavioral: Run-In Sessions 1-5Behavioral: RCT Control SessionBehavioral: RCT Transitions Program Sessions 1-5
- Registration Number
- NCT04450043
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 21
- 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.
- Comorbid health condition that would interfere with study participation
- Current participation in cognitive behavioral therapy treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Run In Run-In Sessions 1-5 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. Control 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. Intervention RCT Transitions Program Sessions 1-5 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.
- Primary Outcome Measures
Name Time Method Proportion of intervention arm participants who complete study visits 12 weeks Feasibility will be assessed by calculating the proportion of intervention arm participants who complete study visits (≥70% attending ≥60% of sessions)
Number of participants retained 12 Weeks Feasibility will be assessed by calculating the proportions of potential participants retained (≥70%)
Number of participants enrolled 12 Weeks Feasibility will be assessed by calculating the proportions of potential participants enrolled (≥35%)
- Secondary Outcome Measures
Name Time Method Change in Hospital Anxiety and Depression Scale score 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.
Change in Multidimensional Scale of Perceived Social Support score 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.
Acceptability of study 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)
Change in Fear of Cancer Recurrence Scale 7 score 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.
Change in Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L) score 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.
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States