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To examine the efficacy of a 10-week multimodal lifestyle program, versus waitlist control, on cardiorespiratory fitness capacity and body weight in survivors of cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal Lifestyle Program | Experimental | The multimodal lifestyle program will utilize intensive behavioral therapy with structured exercise training and nutritional counseling. The main objective of the structured exercise training is to improve cardiorespiratory fitness. |
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| Waitlist Control | No Intervention | The waitlist control group will be asked to maintain their current exercise and dietary habits for the 10-week study period. Upon providing study endpoint data at week 10, control group participants will be offered a 4-week multimodal lifestyle program that is similar to the intervention group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal Lifestyle Program | Behavioral | The multimodal lifestyle program will utilize intensive behavioral therapy with structured exercise training and nutritional counseling. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiorespiratory fitness capacity (co-primary) | Cardiorespiratory fitness (VO2peak) assessed by a symptom-limited cardiopulmonary exercise test. | Baseline, Week 10 |
| Change in body weight (co-primary) | Bodyweight assessed using a digital scale in a fasting state with an empty bladder, without shoes, and only wearing light clothing. | Baseline, Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in waist Circumference | Measured midway between the lower rib margin and the iliac crest. | Baseline, Week 10 |
| Change in fat Mass | Measured by dual-energy x-ray absorptiometry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin C Brown, PhD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41114371 | Derived | Brown JC, Nauta P, Whitehead D, Dubin BR, Nash R, Blumberg K, Green T, Brown J, Compton SLE, Miletello GP. A randomized trial of a multimodal lifestyle intervention in cancer survivors. Front Oncol. 2025 Oct 2;15:1682244. doi: 10.3389/fonc.2025.1682244. eCollection 2025. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Baseline, Week 10 |
| Change in systolic blood pressure | Seating, resting for 5 minutes before the measure is taken | Baseline, Week 10 |
| Change in diastolic blood pressure | Seating, resting for 5 minutes before the measure is taken | Baseline, Week 10 |
| Change in medication use | Medications related to cholesterol, diabetes, and blood pressure | Baseline, Week 10 |
| Change in physical and mental quality-of-life | Assessed using the 36-Item Short Form Survey (SF-36) | Baseline, Week 10 |