Improving Lung Transplant Outcomes With Coping Skills and Physical Activity

Study Overview
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Brief Summary
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This study evaluates the effectiveness of a coping skills and exercise (CSTEX) intervention among post lung transplant patients aimed to reduce distress and improve functional capacity. Half of the patients will receive CSTEX and half will receive the standard of care plus transplant education (SOC-ED).

Detailed Description
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The study will aim to evaluate the effectiveness of the CSTEX intervention in (i) reducing distress and (ii) improving functional capacity. It is hypothesized that compared to SOC-ED, the CSTEX intervention will result in 1) greater reductions in global distress measured by an established psychometric test battery; and 2) greater improvements in functional capacity assessed by distance walked on a standard Six Minute Walk test (6MWT).

Official Title
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Improving Lung Transplant Outcomes With Coping Skills and Physical Activity

Conditions
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Post-Lung Transplantation

Intervention / Treatment
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* Behavioral: Coping Skills Training combined with Exercise (CSTEX)
* Behavioral: Standard of Care plus Education (SOC-ED)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single or bilateral first lung transplant recipient; discharged from the hospital and at least 6 weeks post-transplant; completed post-transplant pulmonary rehabilitation within the past 18 months; on stable medication regimen; proficient in the English language Exclusion Criteria: Illness such as malignancies that are associated with a life-expectancy of < 12 months; current pregnancy; inability to read or to provide informed consent; multi-organ transplant recipient or repeat lung transplant.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coping Skills Training combined with Exercise (CSTEX)<br>The CSTEX intervention will consist of 12, 30 minute weekly sessions conducted by a respiratory therapist knowledgeable about lung transplantation and trained in motivational interviewing, Cognitive Behavioral Therapy (CBT), and exercise therapy. | Behavioral: Coping Skills Training combined with Exercise (CSTEX)<br>* The CSTEX condition has two integrated components: the CST component will systematically train patients in the use of coping skills for stress reduction and promote key transplant-specific health behaviors. The exercise component of the intervention will progressively increase participants exercise and promote daily physical activity through motivational interviewing strategies.<br>|
| Experimental: Standard of Care plus Education (SOC-ED)<br>The SOC-ED intervention will consist of 12, 30 minute weekly sessions conducted by a health educator knowledgeable about transplantation and skilled in educational instruction. | Behavioral: Standard of Care plus Education (SOC-ED)<br>* The SOC-ED condition provides support and enhanced post-transplant education. Participants will be given detailed educational information about post-transplant care, the importance of medication adherence, and maintenance of physical activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Global Psychological Distress | A composite distress score will assess change from baseline to 12 weeks (post-intervention) and combine the following instruments: General Health Questionnaire, Perceived Stress Scale, Beck Depression Inventory-II, State Trait Anxiety Inventory, and PROMIS Anger | Baseline; 12 weeks | 
| Changes in Functional Capacity | Functional capacity will be measured by distance walked on a standard Six Minute Walk Test (6MWT) at baseline and again post-intervention at 12 weeks. | Baseline; 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Physical Activity | Daily physical activity will be assessed via a wrist-worn activity monitor (Actigraph GT9X Link) for 7 consecutive days at baseline and again post-intervention at 12 weeks. | Baseline; 12 weeks | 
| Changes in Sleep Quality | Sleep quality will be assessed via the Pittsburgh Sleep Quality Index at baseline and again post-intervention at 12 weeks. | Baseline; 12 weeks | 
| Changes in Quality of Life | Quality of Life will be assessed via the Lung Transplant Quality of Life Survey, which is comprised of 10 scales that measure symptoms, health perceptions, functioning, and well being at baseline and again post-intervention at 12 weeks. | Baseline; 12 weeks | 
| Clinical Outcomes | The main clinical/medical endpoint will be a measure of chronic lung allograft dysfunction (CLAD) free survival. | Up to 3 years post-treatment |