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| Name | Class |
|---|---|
| American Lung Association | OTHER |
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This is a pilot randomized study to investigate the feasibility, acceptability, safety, and effects of a novel tele-rehabilitation intervention for stage I-IIIA lung cancer survivors following curative intent therapy.
The specific aims and hypotheses are:
Specific Aim 1: Conduct a pilot, phase IIb, parallel randomized (1:1) study to investigate the feasibility, acceptability, and safety of inspiratory muscle training and behavioral support to promote walking in tele-rehabilitation with stage I-IIIA lung cancer survivors following curative intent therapy (N=40).
Hypothesis 1a: ≥ 20% eligible patients will enroll; ≥75% of participants will achieve ≥75% adherence to the tele-rehabilitation program.
Hypothesis 1b: ≥75% of participants will perceive tele-rehabilitation as acceptable (Telemedicine Satisfaction and Usefulness Questionnaire ≥4). There will be 0 intervention adverse events.
Specific Aim 2: Explore the effects of the tele-rehabilitation program (N=40).
Hypothesis 2: At 12 weeks, participants in the tele-rehabilitation (experimental) arm, compared to education only (control) arm, will have a trend of greater improvements in outcomes, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tele-rehabilitation | Experimental | Participants in the tele-rehabilitation arm will receive a home-based, remotely delivered rehabilitation program. |
|
| Education only | Active Comparator | Participants in the education arm will receive educational materials only, delivered through telecommunication messages. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-rehabilitation | Behavioral | The tele-rehabilitation intervention will include education, inspiratory muscle training, and behavioral support to promote walking. |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference in change in accelerometry-measured physical activity between baseline and week 12 | Physical activity will be measured by the activPAL4 device (PAL Technologies, Ltd). | Baseline, mid study (week 6), and end of study (week 12). |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in change in functional capacity between baseline and week 12 | Functional capacity will be measured using the mobile six-minute walk test. | Baseline, mid study (week 6), and end of study (week 12) |
| Difference in change in self-reported physical activity between baseline and week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Colorado | Aurora | Colorado | 80014 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37656252 | Result | Ha DM, Comer A, Dollar B, Bedoy R, Ford M, Gozansky WS, Zeng C, Arch JJ, Leach HJ, Malhotra A, Prochazka AV, Keith RL, Boxer RS. Telemedicine-based inspiratory muscle training and walking promotion with lung cancer survivors following curative intent therapy: a parallel-group pilot randomized trial. Support Care Cancer. 2023 Sep 1;31(9):546. doi: 10.1007/s00520-023-07999-7. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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This is a pilot, parallel randomized study of an exercise + behavioral support intervention to reduce dyspnea and improve walking behavior among lung cancer survivors following curative intent therapy. Forty participants will be randomized 1:1 to the intervention or control arm, with assessments of feasibility, acceptability, safety, and patient-centered outcomes. The intervention period is 12 weeks.
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| Education only | Other | The education only arm will receive information on the importance of general exercise following lung cancer treatment. |
|
Self-reported physical activity will be measured using the International Physical Activity Questionnaire - Short Form |
| Baseline, mid study (week 6), and end of study (week 12) |
| Difference in change in control of dyspnea between baseline and week 12 | Dyspnea control will be measured using the the University of California, San Diego Shortness of Breath Questionnaire. | Baseline, mid study (week 6), and end of study (week 12) |
| Difference in change in anxiety symptoms between baseline and week 12 | Anxiety symptoms will be measured using the General Anxiety Disorder-7 | Baseline, mid study (week 6), and end of study (week 12) |
| Difference in change in sleep quality between baseline and week 12 | Sleep quality will be measured using the Pittsburgh Sleep Quality Index | Baseline, mid study (week 6), and end of study (week 12) |
| Difference in change in quality of life between baseline and week 12 | Quality of life will be measured using the St. George's Respiratory Questionnaire | Baseline, mid study (week 6), and end of study (week 12) |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |