Improving Lung Transplant Outcomes With Coping Skills and Physical Activity

Not Applicable

Active, not recruiting

• Conditions: Post-Lung Transplantation
• Interventions: Behavioral: Standard of Care plus Education (SOC-ED); Behavioral: Coping Skills Training combined with Exercise (CSTEX)

• Registration Number: NCT04093869
• Lead Sponsor: Duke University

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2019-09-06
• Study First Submitted QC: 2019-09-17
• Study First Posted: 2019-09-18
• Study Start: 2019-11-06
• Primary Completion: 2024-02-21
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-14
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 180

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care plus Education (SOC-ED)	Standard of Care plus Education (SOC-ED)	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.
Coping Skills Training combined with Exercise (CSTEX)	Coping Skills Training combined with Exercise (CSTEX)	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.

Primary Outcome Measures

Name	Time	Method
Change in Global Psychological Distress	Baseline; 12 weeks	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

Secondary Outcome Measures

Name	Time	Method
Changes in Coping	Baseline; 12 weeks	Coping will be assessed via the Brief COPE Inventory, which is composed of scales that measure problem-focused coping, emotion-focused coping, and avoidant coping responses at baseline and again post-intervention at 12 weeks. Items are scored on a 4-point Likert scale, with 1 indicating a coping mechanism that the participant has not been doing at all, to 4 indicating a coping mechanism in which the participant has been doing a lot. A higher score within the problem-focused and emotion-focused coping subscales indicate better coping strategies, a lower score within the avoidant coping subscale indicates a more useful coping strategy.
Changes in Functional Capacity	Baseline; 12 weeks	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.
Changes in Physical Activity	Baseline; 12 weeks	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.
Changes in Sleep Quality	Baseline; 12 weeks	Sleep quality will be assessed via the Pittsburgh Sleep Quality Index at baseline and again post-intervention at 12 weeks.
Changes in Quality of Life	Baseline; 12 weeks	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.
Changes in Frailty	Baseline; 12 weeks	Frailty will be measured by performance on the Fried Frailty Index. This assessment includes measures on patient's weight, exhaustion level, physical activity, walking speed, and hand grip strength at baseline and again post-intervention at 12 weeks. Scores are based on the participants performance with lower scores indicating less frailty.
Changes in Self-Efficacy	Baseline; 12 weeks	Self-efficacy will be assessed via the General Self-Efficacy Scale, which is a 10-item scale that measures emotional distress at baseline and again post-intervention at 12 weeks. Scores range from 10-40 with a higher score indicating better self-efficacy.
Clinical Outcomes	Up to 3 years post-treatment	The main clinical/medical endpoint will be a measure of chronic lung allograft dysfunction (CLAD) free survival.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States