The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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.
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In the first part of this study, about 5 participants will complete survey questions and receive a 5-session program.
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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).
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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
Arms and Interventions
| 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.
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| 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.
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| 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
Primary Outcome Measures
- Number of participants enrolled [12 Weeks]
Feasibility will be assessed by calculating the proportions of potential participants enrolled (≥35%)
- Number of participants retained [12 Weeks]
Feasibility will be assessed by calculating the proportions of potential participants retained (≥70%)
- 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)
Secondary Outcome Measures
- 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 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.
- 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 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 21 or older
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Diagnosis of non-small cell (NSCLC) or small cell (SCLC) lung cancer or mesothelioma
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Documented treatment plan with curative intent
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Ability to read and respond in English
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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.
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If final treatment is systemic therapy +/- radiation: within three weeks after cancer care team determination that treatment is complete.
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If final treatment is surgery: within three weeks after hospital discharge following surgery.
Exclusion Criteria:
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Comorbid health condition that would interfere with study participation
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Current participation in cognitive behavioral therapy treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
- Principal Investigator: Lara Traeger, Ph.D, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-140