The Transitions Project: Efficacy Trial
Purpose
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.
Condition
- Lung Cancer
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- Comorbid health condition that would interfere with study participation - Current participation in cognitive behavioral therapy treatment
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention: Five Psycho-educational Sessions |
Approximately 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. |
|
|
Experimental Enhanced Usual Care: One Psycho-educational Session |
At 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. |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
Detailed Description
This is a randomized controlled trial to test the efficacy of a brief psychoeducational intervention relative to a control condition for improving quality of life in patients with lung cancer who are transitioning from treatment to surveillance. In this study, participants will complete survey questions and will be randomly assigned to receive a 5-session program or a 1-session program. It is expected that about 100 people will take part in this research study. The American Lung Association is supporting this research by providing funding for the research study.