Trial Outcomes & Findings for Improving Lung Transplant Outcomes With Coping Skills and Physical Activity (NCT NCT04093869)

NCT ID: NCT04093869

Last Updated: 2025-03-04

Results Overview

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. The composite distress score is the average of the participant's rank for change (from baseline to 12 weeks) on each of the 5 scales. A lower rank represents more improvement (decrease in global distress) and higher ranks represent less improvement (or worsening of distress). Scoring is based on the number of participants analyzed; in this case the possible score range is 1-180. The change value is calculated as T2 (12 weeks) - T1 (baseline).

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 180 participants
• Primary outcome timeframe: Baseline to 12 weeks
• Results posted on: 2025-03-04

Participant Flow

Participants were randomly assigned in a 1:1 ratio to either CSTEX condition delivered over the telephone or to a standard of care plus transplant education (SoC-ED) control condition.

Participant milestones

Measure	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. Coping Skills Training combined with Exercise (CSTEX): 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.	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. Standard of Care plus Education (SOC-ED): 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.
Overall Study STARTED	90	90
Overall Study COMPLETED	89	89
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	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. Coping Skills Training combined with Exercise (CSTEX): 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.	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. Standard of Care plus Education (SOC-ED): 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.
Overall Study Death	0	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Improving Lung Transplant Outcomes With Coping Skills and Physical Activity

Baseline characteristics by cohort

Measure	Coping Skills Training Combined With Exercise (CSTEX) n=90 Participants 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. Coping Skills Training combined with Exercise (CSTEX): 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.	Standard of Care Plus Education (SOC-ED) n=90 Participants 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. Standard of Care plus Education (SOC-ED): 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.	Total n=180 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 12 • n=5 Participants	60 years STANDARD_DEVIATION 12 • n=7 Participants	60 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	37 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	53 Participants n=7 Participants	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	89 Participants n=5 Participants	88 Participants n=7 Participants	177 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) White	77 Participants n=5 Participants	74 Participants n=7 Participants	151 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	90 Participants n=5 Participants	90 Participants n=7 Participants	180 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: 3 participants were excluded because they had missing values for at least one of the instruments that contributed to the composite distress score.

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. The composite distress score is the average of the participant's rank for change (from baseline to 12 weeks) on each of the 5 scales. A lower rank represents more improvement (decrease in global distress) and higher ranks represent less improvement (or worsening of distress). Scoring is based on the number of participants analyzed; in this case the possible score range is 1-180. The change value is calculated as T2 (12 weeks) - T1 (baseline).

Outcome measures

Measure	Coping Skills Training Combined With Exercise (CSTEX) n=88 Participants 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. Coping Skills Training combined with Exercise (CSTEX): 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.	Standard of Care Plus Education (SOC-ED) n=89 Participants 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. Standard of Care plus Education (SOC-ED): 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.
Change in Global Psychological Distress	91 units on a scale Standard Deviation 40	87 units on a scale Standard Deviation 33

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Assessment of functional capacity was limited due to the inability of participants to attend in person visits during COVID-19. Seventy-one participants were unable to complete the 6MWT at baseline and/or post-intervention.

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. Distance measured in feet. Greater distance represents better functional capacity. The change value is calculated as T2 (12 weeks) - T1 (baseline).

Outcome measures

Measure	Coping Skills Training Combined With Exercise (CSTEX) n=52 Participants 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. Coping Skills Training combined with Exercise (CSTEX): 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.	Standard of Care Plus Education (SOC-ED) n=57 Participants 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. Standard of Care plus Education (SOC-ED): 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.
Change in Functional Capacity	1451 feet Standard Deviation 332	1472 feet Standard Deviation 262

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 5 participants had missing data for the baseline and/or post-intervention physical activity (steps) measurement.

Daily physical activity (average steps per day) 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. The change value is calculated as T2 (12 weeks) - T1 (baseline).

Outcome measures

Measure	Coping Skills Training Combined With Exercise (CSTEX) n=87 Participants 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. Coping Skills Training combined with Exercise (CSTEX): 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.	Standard of Care Plus Education (SOC-ED) n=88 Participants 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. Standard of Care plus Education (SOC-ED): 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.
Change in Physical Activity	8037 steps per day Standard Deviation 3103	8612 steps per day Standard Deviation 3161

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 8 participants were missing a PSQI score at baseline and/or post-intervention.

Sleep quality (average total minutes of sleep per night) will be assessed via the Pittsburgh Sleep Quality Index at baseline and again post-intervention at 12 weeks. The change value is calculated as T2 (12 weeks) - T1 (baseline).

Outcome measures

Measure	Coping Skills Training Combined With Exercise (CSTEX) n=86 Participants 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. Coping Skills Training combined with Exercise (CSTEX): 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.	Standard of Care Plus Education (SOC-ED) n=86 Participants 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. Standard of Care plus Education (SOC-ED): 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.
Change in Sleep Quality	421 minutes per night Standard Deviation 92	401 minutes per night Standard Deviation 66

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Two participants were missing a QOL score at baseline and/or post-intervention.

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. The QOL overall score ranges from 1 to 5, with a higher score indicating worse health. The change value is calculated as T2 (12 weeks) - T1 (baseline).

Outcome measures

Measure	Coping Skills Training Combined With Exercise (CSTEX) n=89 Participants 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. Coping Skills Training combined with Exercise (CSTEX): 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.	Standard of Care Plus Education (SOC-ED) n=89 Participants 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. Standard of Care plus Education (SOC-ED): 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.
Change in Quality of Life	1.78 score on a scale Standard Deviation 0.49	1.78 score on a scale Standard Deviation 0.56

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Assessment of frailty was limited due to the inability of participants to attend in person visits during COVID-19. Sixty-eight participants were missing the Fried Frailty Index measurement at baseline and/or post-intervention.

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 range from 0 to 5, with lower scores indicating less frailty. The change value is calculated as T2 (12 weeks) - T1 (baseline).

Outcome measures

Measure	Coping Skills Training Combined With Exercise (CSTEX) n=54 Participants 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. Coping Skills Training combined with Exercise (CSTEX): 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.	Standard of Care Plus Education (SOC-ED) n=58 Participants 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. Standard of Care plus Education (SOC-ED): 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.
Change in Frailty	0.62 score on a scale Standard Deviation 0.74	0.52 score on a scale Standard Deviation 0.73

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Two participants were missing a Brief COPE score at baseline and/or post-intervention.

Coping was 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 average score within the problem-focused subscale indicates better coping strategies. The change value is calculated as T2 (12 weeks) - T1 (baseline).

Outcome measures

Measure	Coping Skills Training Combined With Exercise (CSTEX) n=89 Participants 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. Coping Skills Training combined with Exercise (CSTEX): 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.	Standard of Care Plus Education (SOC-ED) n=89 Participants 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. Standard of Care plus Education (SOC-ED): 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.
Change in Problem-Focused Coping	2.64 score on a scale Standard Deviation 0.79	2.73 score on a scale Standard Deviation 0.79

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Two participants were missing a Brief COPE score at baseline and/or post-intervention.

Coping was 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 emotion-focused coping subscale indicates better coping strategies. The change value is calculated as T2 (12 weeks) - T1 (baseline).

Outcome measures

Measure	Coping Skills Training Combined With Exercise (CSTEX) n=89 Participants 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. Coping Skills Training combined with Exercise (CSTEX): 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.	Standard of Care Plus Education (SOC-ED) n=89 Participants 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. Standard of Care plus Education (SOC-ED): 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.
Change in Emotion-Focused Coping	2.26 score on a scale Standard Deviation 0.51	2.25 score on a scale Standard Deviation 0.49

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Two participants were missing a Brief COPE score at baseline and/or post-intervention.

Coping was 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 lower score within the avoidant coping subscale indicates a more useful coping strategy. The change value is calculated as T2 (12 weeks) - T1 (baseline).

Outcome measures

Measure	Coping Skills Training Combined With Exercise (CSTEX) n=89 Participants 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. Coping Skills Training combined with Exercise (CSTEX): 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.	Standard of Care Plus Education (SOC-ED) n=89 Participants 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. Standard of Care plus Education (SOC-ED): 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.
Change in Avoidant Coping	1.45 score on a scale Standard Deviation 0.36	1.46 score on a scale Standard Deviation 0.34

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 5 participants were missing a GSE score at baseline and/or post-intervention.

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. The change value is calculated as T2 (12 weeks) - T1 (baseline).

Outcome measures

Measure	Coping Skills Training Combined With Exercise (CSTEX) n=89 Participants 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. Coping Skills Training combined with Exercise (CSTEX): 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.	Standard of Care Plus Education (SOC-ED) n=86 Participants 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. Standard of Care plus Education (SOC-ED): 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.
Change in Self-Efficacy	33.3 score on a scale Standard Deviation 5.1	33.1 score on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: Up to 3 years post-treatment

Outcome measures

Outcome data not reported

Adverse Events

Coping Skills Training Combined With Exercise (CSTEX)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care Plus Education (SOC-ED)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephanie K. Mabe, MS

Duke University

Phone: 919-668-3555

Email: stephanie.mabe@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place