Cognitive Behavioral Therapy, Mesothelioma, Non Small Cell Lung Cancer, Small-cell Lung Cancer
Conditions
Keywords
Non Small Cell Lung Cancer, Small-cell Lung Cancer, Mesothelioma, Cognitive Behavioral Therapy
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.
Interventions
BEHAVIORALRun-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.
BEHAVIORALRCT Transitions Program Sessions 1-5
Sessions 1-5 focuses on learning and practicing skills to enhance post-treatment quality of life.
BEHAVIORALRCT 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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLara Traeger, Ph.D
Massachusetts General Hospital
Outcome results
None listed