A Trial of a Multimodal Lifestyle Intervention to Optimize Survivorship After Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Trial of a Multimodal Lifestyle Intervention to Optimize Survivorship After Cancer

Conditions
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Neoplasm Malignant

Intervention / Treatment
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* Behavioral: Multimodal Lifestyle Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide informed consent before any trial-related activities History of any malignancy 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) No evidence of residual or recurrent cancer under active treatment Age ≥18 years Body mass index (BMI) ≥30 kg/m2 or BMI ≥27 kg/m2 with one or more treated or untreated weight-related coexisting conditions Willing to be randomized Allow the collection and storage of biospecimens and data for future use Exclusion Criteria: Engaging in ≥3 purposeful exercise sessions per week, on average, over the past 12 weeks Significant purposeful weight loss (>11 kg) within the past 12 weeks Current use of medications or devices for the purpose of weight loss Metabolic or bariatric surgery within the last year Cardiovascular, respiratory, or musculoskeletal disease that would prohibit participation in an exercise and weight loss program Currently pregnant, breastfeeding, or planning to become pregnant with the next 12 weeks Psychiatric disorders or conditions that would preclude participation in the study intervention 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimodal Lifestyle Program<br>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<br>* The multimodal lifestyle program will utilize intensive behavioral therapy with structured exercise training and nutritional counseling.<br>|
| No Intervention: Waitlist Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |