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Symptom burden remains a critical concern for individuals with non-small cell lung cancer (NSCLC) following the completion of treatment. Of those, symptom clusters such as dyspnea (shortness of breath) and fatigue, contribute to physical decline, reductions in quality of life, and a higher risk of comorbidities and mortality. It has been proposed that dyspnea is a primary limiter of exercise capacity in individuals with lung cancer, resulting in exercise avoidance and an accelerated physical decline. As such, specifically designing resistance exercise programs with cluster sets, to mitigate feelings of dyspnea and fatigue may result in improved exercise tolerance, resulting in the maintenance of physical function and quality of life.
The purpose of this project is to investigate the feasibility and preliminary efficacy of a hybrid-delivery of home-based cluster-set resistance exercise in individuals with NSCLC. Methods: Individuals with NSCLC (n=15), within 12-months of completion of treatment will be recruited to participate in this single arm feasibility trial. Participants will complete 8-weeks of home-based resistance training (RT) designed to target dyspnea and fatigue. The hybrid-delivery of the program will include supervised sessions in the participants home, and virtual supervision via video conferencing. The primary outcome of feasibility will be measured via recruitment rates, retention, acceptability and intervention fidelity. Exploratory outcomes (dyspnea, fatigue, quality of life, physical function and body composition) will be assessed pre- and post- intervention.
Analysis plan. Descriptive statistics (percentages and means (with standard deviations)) will be used to report on feasibility outcomes (recruitment, retention, fidelity etc.). Unless explicitly stated, means and standard deviations will be reported for assessments of exploratory outcomes at baseline and follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistance Exercise | Behavioral | This is an 8-week exercise program, delivered using a hybrid approach of in-person, in-home supervised exercise, and virtual delivery of exercise via zoom. Individuals will participate in resistance exercise 3 days per week for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | The recruitment goal of n=15 is reached | Through study completion, an average of 1 year |
| Retention | If ≥75% of the sample recruited to participate return for follow up testing | Through study completion, an average of 1 year |
| Intervention Fidelity | Exercise fidelity will be reported using metrics previously outlines by Fairman et al (2019). Specifically, volume load will be calculated as a function of sets x reps for each exercise and summed to give total volume for each session. We will report the proportion of volume achieved relevant to what was prescribed to give a "relative-dose intensity" (RDI) for each person. RDI will then be averaged and used to determine fidelity to the RT intervention. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | 10-item scale adapted from McDonnell et al (PMID: 33118443). Questions assessing the acceptability of the intervention will be scored on a 4-point Likert-Type scale from "Strongly disagree" to "Strongly Agree". Questions will ask about the utility of virtual exercise sessions, use of technology and level of tailoring the intervention | At post intervention (8-weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina | Columbia | South Carolina | 29201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37848969 | Derived | Fairman CM, Owens OL, Kendall KL, Steele J, Schumpp AR, Latella C, Jones MT, Marcotte L, Dawson JM, Peddle-McIntyre CMJ, McDonnell KK. Hybrid delivery of cluster-set resistance training for individuals previously treated for lung cancer: the results of a single-arm feasibility trial. Pilot Feasibility Stud. 2023 Oct 17;9(1):177. doi: 10.1186/s40814-023-01405-z. |
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All de-identified data and code for analyses will be made available as soon as possible with publication of the primary outcome paper. The dataset will include demographic information, and physiological and psychosocial measures outlined in the proposal.
All de-identified data and code for analyses will be made available as soon as possible with publication of the primary outcome paper.
We will make the de-identified data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed.
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009043 | Motor Activity |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Single-arm feasibility trial
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| Dyspnea | Functional Assessment of Chronic Illness Therapy-Dyspnea (FACIT-D) 10-Item short form (parts 1 and 2). Part 1 assesses Dyspnea and Part 2 assesses dyspnea-associated functional limitations. Min score for each part: 0; max score for each part: 30. Higher scores indicate worse dyspnea/burden | Baseline and post intervention (8-weeks) |
| Fatigue | Functional Assessment of Chronic Illness Therapy-Fatigue scale 13-item scale. Min score: 0 Max score: 52 Higher scores mean higher quality of life. | Baseline and post intervention (8-weeks) |
| Lung Cancer Related Quality of Life | Functional Assessment of Cancer Therapy - Lung Cancer Subscale (LCS). Min score: 0; max score: 28. Higher scores indicate better quality of life. | Baseline and post intervention (8-weeks) |
| Upper Body Muscular Strength | Chest Press five repetition maximum | Baseline and post intervention (8-weeks) |
| Lower Body Muscular Strength | Leg Press five repetition maximum | Baseline and post intervention (8-weeks) |
| Physical Function STS | 5 times sit-to-stand (in seconds) | Baseline and post intervention (8-weeks) |
| Physical Function 6MWT | 6-minute Walk Test (distance in meters) | Baseline and post intervention (8-weeks) |
| Fat Mass | Fat mass (kg) Dual Energy X-Ray Absorptiometry | Baseline and post intervention (8-weeks) |
| Fat Free Mass | Fat Free Mass (kg) Dual Energy X-Ray Absorptiometry | Baseline and post intervention (8-weeks) |
| Total Mass | Total Mass (kg) Dual Energy X-Ray Absorptiometry | Baseline and post intervention (8-weeks) |
| Body Fat Percentage | Dual Energy X-Ray Absorptiometry | Baseline and post intervention (8-weeks) |
| Appendicular Lean Mass | Sum of Arm and Leg Fat Free Mass | Baseline and post intervention (8-weeks) |
| Bone Mineral Density | Total z-score Dual X-ray Absorptiometry | Baseline and post intervention (8-weeks) |
| Acceptability | Qualitative interview with participants regarding the acceptability, likes, dislikes about the intervention and potential barriers for future participation. | Post-Intervention (8-weeks) |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |