Post-Lung Transplantation
Conditions
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).
Interventions
BEHAVIORALCoping 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.
BEHAVIORALStandard 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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Global Psychological Distress | Baseline to 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. 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Capacity | Baseline to 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. Distance measured in feet. Greater distance represents better functional capacity. The change value is calculated as T2 (12 weeks) - T1 (baseline). |
| Change in Physical Activity | Baseline to 12 weeks | 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). |
| Change in Sleep Quality | Baseline to 12 weeks | 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). |
| Change in Quality of Life | Baseline to 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. 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). |
| Change in Frailty | Baseline to 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 range from 0 to 5, with lower scores indicating less frailty. The change value is calculated as T2 (12 weeks) - T1 (baseline). |
| Change in Problem-Focused Coping | Baseline to 12 weeks | 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). |
| Change in Emotion-Focused Coping | Baseline to 12 weeks | 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). |
| Change in Avoidant Coping | Baseline to 12 weeks | 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). |
| Change in Self-Efficacy | Baseline to 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. The change value is calculated as T2 (12 weeks) - T1 (baseline). |
| Chronic Lung Allograft Dysfunction (CLAD) Free Survival | Up to 3 years post-treatment | — |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 90 |
| 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. | 90 |
| Total | 180 |
Baseline characteristics
| Characteristic | Standard of Care Plus Education (SOC-ED) | Total | Coping Skills Training Combined With Exercise (CSTEX) |
|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 12 | 60 years STANDARD_DEVIATION 12 | 60 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 88 Participants | 177 Participants | 89 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 25 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 74 Participants | 151 Participants | 77 Participants |
| Region of Enrollment United States | 90 Participants | 180 Participants | 90 Participants |
| Sex: Female, Male Female | 37 Participants | 72 Participants | 35 Participants |
| Sex: Female, Male Male | 53 Participants | 108 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 1 / 90 |
| other Total, other adverse events | 0 / 90 | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 | 0 / 90 |
Outcome results
Primary
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. 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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Skills Training Combined With Exercise (CSTEX) | Change in Global Psychological Distress | 91 units on a scale | Standard Deviation 40 |
| Standard of Care Plus Education (SOC-ED) | Change in Global Psychological Distress | 87 units on a scale | Standard Deviation 33 |
p-value: 0.495% CI: [-6, 14]Regression, Linear
Secondary
Change in Avoidant Coping
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).
Time frame: Baseline to 12 weeks
Population: Two participants were missing a Brief COPE score at baseline and/or post-intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Skills Training Combined With Exercise (CSTEX) | Change in Avoidant Coping | 1.45 score on a scale | Standard Deviation 0.36 |
| Standard of Care Plus Education (SOC-ED) | Change in Avoidant Coping | 1.46 score on a scale | Standard Deviation 0.34 |
95% CI: [-0.12, 0.07]
Secondary
Change in Emotion-Focused Coping
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).
Time frame: Baseline to 12 weeks
Population: Two participants were missing a Brief COPE score at baseline and/or post-intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Skills Training Combined With Exercise (CSTEX) | Change in Emotion-Focused Coping | 2.26 score on a scale | Standard Deviation 0.51 |
| Standard of Care Plus Education (SOC-ED) | Change in Emotion-Focused Coping | 2.25 score on a scale | Standard Deviation 0.49 |
95% CI: [-0.13, 0.1]
Secondary
Change in Frailty
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Skills Training Combined With Exercise (CSTEX) | Change in Frailty | 0.62 score on a scale | Standard Deviation 0.74 |
| Standard of Care Plus Education (SOC-ED) | Change in Frailty | 0.52 score on a scale | Standard Deviation 0.73 |
95% CI: [-0.22, 0.3]
Secondary
Change 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. Distance measured in feet. Greater distance represents better functional capacity. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Skills Training Combined With Exercise (CSTEX) | Change in Functional Capacity | 1451 feet | Standard Deviation 332 |
| Standard of Care Plus Education (SOC-ED) | Change in Functional Capacity | 1472 feet | Standard Deviation 262 |
95% CI: [-44, 85]
Secondary
Change in Physical Activity
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).
Time frame: Baseline to 12 weeks
Population: 5 participants had missing data for the baseline and/or post-intervention physical activity (steps) measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Skills Training Combined With Exercise (CSTEX) | Change in Physical Activity | 8037 steps per day | Standard Deviation 3103 |
| Standard of Care Plus Education (SOC-ED) | Change in Physical Activity | 8612 steps per day | Standard Deviation 3161 |
95% CI: [-979, 346]
Secondary
Change in Problem-Focused Coping
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).
Time frame: Baseline to 12 weeks
Population: Two participants were missing a Brief COPE score at baseline and/or post-intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Skills Training Combined With Exercise (CSTEX) | Change in Problem-Focused Coping | 2.64 score on a scale | Standard Deviation 0.79 |
| Standard of Care Plus Education (SOC-ED) | Change in Problem-Focused Coping | 2.73 score on a scale | Standard Deviation 0.79 |
95% CI: [-0.2, 0.17]
Secondary
Change 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. 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).
Time frame: Baseline to 12 weeks
Population: Two participants were missing a QOL score at baseline and/or post-intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Skills Training Combined With Exercise (CSTEX) | Change in Quality of Life | 1.78 score on a scale | Standard Deviation 0.49 |
| Standard of Care Plus Education (SOC-ED) | Change in Quality of Life | 1.78 score on a scale | Standard Deviation 0.56 |
95% CI: [-0.1, 0.11]
Secondary
Change in Self-Efficacy
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).
Time frame: Baseline to 12 weeks
Population: 5 participants were missing a GSE score at baseline and/or post-intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Skills Training Combined With Exercise (CSTEX) | Change in Self-Efficacy | 33.3 score on a scale | Standard Deviation 5.1 |
| Standard of Care Plus Education (SOC-ED) | Change in Self-Efficacy | 33.1 score on a scale | Standard Deviation 4.7 |
95% CI: [-0.83, 1.6]
Secondary
Change in Sleep Quality
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).
Time frame: Baseline to 12 weeks
Population: 8 participants were missing a PSQI score at baseline and/or post-intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Skills Training Combined With Exercise (CSTEX) | Change in Sleep Quality | 421 minutes per night | Standard Deviation 92 |
| Standard of Care Plus Education (SOC-ED) | Change in Sleep Quality | 401 minutes per night | Standard Deviation 66 |
95% CI: [-5, 34]
Secondary
Chronic Lung Allograft Dysfunction (CLAD) Free Survival
Time frame: Up to 3 years post-treatment