A Trial of a Multimodal Lifestyle Intervention to Optimize Survivorship After Cancer (Small Steps)

Pennington Biomedical Research Center

Status: Active, not recruiting

Conditions: Neoplasm Malignant

Treatments: Behavioral: Multimodal Lifestyle Program

Study type: Interventional

Funder types: Other

Identifiers

NCT04987359

PBRC 2021-013

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

Multimodal Lifestyle Program

Experimental group

Description:

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.

Treatment:

Behavioral: Multimodal Lifestyle Program

Waitlist Control

No Intervention group

Description:

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.