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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coping Skills Training combined with Exercise (CSTEX) | Experimental | 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. |
|
| Standard of Care plus Education (SOC-ED) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coping Skills Training combined with Exercise (CSTEX) | Behavioral | 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. |
| 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. 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). | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40180232 | Derived | Blumenthal JA, Mabe S, Arthur D, Frankel C, McKee DC, Morrison S, Sherwood A, Snyder LD, Palmer SM; INSPIRE III Investigators. Telehealth interventions to improve outcomes in lung transplant recipients: Primary results of the INSPIRE-III randomized clinical trial. J Heart Lung Transplant. 2025 Sep;44(9):1449-1459. doi: 10.1016/j.healun.2025.03.017. Epub 2025 Apr 1. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 3 participants were excluded because they had missing values for at least one of the instruments that contributed to the composite distress score. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 weeks |
|
Baseline through post-intervention assessments, approximately 12 weeks
The only Adverse Events collected were hospitalization and death.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie K. Mabe, MS | Duke University | 919-668-3555 | stephanie.mabe@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2024 | Dec 4, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 19, 2022 | Nov 1, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D059039 | Standard of Care |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Standard of Care plus Education (SOC-ED) | Behavioral | 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 | 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). | Baseline to 12 weeks |
| 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). | Baseline to 12 weeks |
| 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). | Baseline to 12 weeks |
| 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). | Baseline to 12 weeks |
| 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). | Baseline to 12 weeks |
| 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). | Baseline to 12 weeks |
| 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). | Baseline to 12 weeks |
| 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). | Baseline to 12 weeks |
| Chronic Lung Allograft Dysfunction (CLAD) Free Survival | Up to 3 years post-treatment |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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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. |
| OG001 | 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. |
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| 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). | 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. | Posted | Mean | Standard Deviation | feet | Baseline to 12 weeks |
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| 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). | 5 participants had missing data for the baseline and/or post-intervention physical activity (steps) measurement. | Posted | Mean | Standard Deviation | steps per day | Baseline to 12 weeks |
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| 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). | 8 participants were missing a PSQI score at baseline and/or post-intervention. | Posted | Mean | Standard Deviation | minutes per night | Baseline to 12 weeks |
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| 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). | Two participants were missing a QOL score at baseline and/or post-intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks |
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| 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). | Two participants were missing a Brief COPE score at baseline and/or post-intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks |
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| 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). | Two participants were missing a Brief COPE score at baseline and/or post-intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks |
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| 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). | Two participants were missing a Brief COPE score at baseline and/or post-intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks |
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| 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). | 5 participants were missing a GSE score at baseline and/or post-intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks |
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| Secondary | Chronic Lung Allograft Dysfunction (CLAD) Free Survival | Not Posted | Up to 3 years post-treatment | Participants |
| 0 |
| 90 |
| 0 |
| 90 |
| 0 |
| 90 |
| EG001 | 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. | 1 | 90 | 0 | 90 | 0 | 90 |
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| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |