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

Not Applicable

Active, not recruiting

• Conditions: Neoplasm Malignant
• Interventions: Behavioral: Multimodal Lifestyle Program

• Registration Number: NCT04987359
• Lead Sponsor: Pennington Biomedical Research Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-03
• Study Start: 2021-08-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimodal Lifestyle Program	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in systolic 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 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 diastolic blood pressure	Baseline, Week 10	Seating, resting for 5 minutes before the measure is taken
Change in physical and mental quality-of-life	Baseline, Week 10	Assessed using the 36-Item Short Form Survey (SF-36)

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States