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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neoplasm Malignant
• Intervention / Treatment: Behavioral: Multimodal Lifestyle Program

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Justin C Brown, PhD, Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: PBRC 2021-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No