Small Steps: A Trial of a Multimodal Lifestyle Intervention to Optimize Survivorship After Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Multimodal Lifestyle Program 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. |
Behavioral: Multimodal Lifestyle Program
The multimodal lifestyle program will utilize intensive behavioral therapy with structured exercise training and nutritional counseling.
|
| No Intervention: Waitlist Control 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. |
Outcome Measures
Primary Outcome Measures
- Change in cardiorespiratory fitness capacity (co-primary) [Baseline, Week 10]
Cardiorespiratory fitness (VO2peak) assessed by a symptom-limited cardiopulmonary exercise test.
- Change in body weight (co-primary) [Baseline, Week 10]
Bodyweight assessed using a digital scale in a fasting state with an empty bladder, without shoes, and only wearing light clothing.
Secondary Outcome Measures
- Change in waist Circumference [Baseline, Week 10]
Measured midway between the lower rib margin and the iliac crest.
- Change in fat Mass [Baseline, Week 10]
Measured by dual-energy x-ray absorptiometry
- Change in systolic blood pressure [Baseline, Week 10]
Seating, resting for 5 minutes before the measure is taken
- Change in diastolic blood pressure [Baseline, Week 10]
Seating, resting for 5 minutes before the measure is taken
- Change in medication use [Baseline, Week 10]
Medications related to cholesterol, diabetes, and blood pressure
- Change in physical and mental quality-of-life [Baseline, Week 10]
Assessed using the 36-Item Short Form Survey (SF-36)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ability to provide informed consent before any trial-related activities
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History of any malignancy
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Completion of cancer-directed therapy (e.g., surgery, chemotherapy, and radiotherapy) prior to enrollment (patients receiving ongoing endocrine or targeted therapy are eligible to participate)
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No evidence of residual or recurrent cancer under active treatment
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Age ≥18 years
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Body mass index (BMI) ≥30 kg/m2 or BMI ≥27 kg/m2 with one or more treated or untreated weight-related coexisting conditions
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Willing to be randomized
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Allow the collection and storage of biospecimens and data for future use
Exclusion Criteria:
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Engaging in ≥3 purposeful exercise sessions per week, on average, over the past 12 weeks
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Significant purposeful weight loss (>11 kg) within the past 12 weeks
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Current use of medications or devices for the purpose of weight loss
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Metabolic or bariatric surgery within the last year
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Cardiovascular, respiratory, or musculoskeletal disease that would prohibit participation in an exercise and weight loss program
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Currently pregnant, breastfeeding, or planning to become pregnant with the next 12 weeks
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Psychiatric disorders or conditions that would preclude participation in the study intervention
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Any other condition which, in the opinion of the investigator, may impede testing of the study hypothesis or make it unsafe to engage in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pennington Biomedical Research Center | Baton Rouge | Louisiana | United States | 70808 |
Sponsors and Collaborators
- Pennington Biomedical Research Center
Investigators
- Principal Investigator: Justin C Brown, PhD, Pennington Biomedical Research Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-013