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

NCT04987359 | Active Not Recruiting

• 1 other identifier: PBRC 2021-013
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasm Malignant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change in waist Circumference

  Baseline, Week 10

• Change in fat Mass

  Baseline, Week 10

• Change in systolic blood pressure

  Baseline, Week 10

• Change in diastolic blood pressure

  Baseline, Week 10

• Change in medication use

  Baseline, Week 10

Study Arms (2)

Multimodal Lifestyle Program

EXPERIMENTAL

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

Waitlist Control

NO INTERVENTION

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.

Interventions

Multimodal Lifestyle Program BEHAVIORAL

The multimodal lifestyle program will utilize intensive behavioral therapy with structured exercise training and nutritional counseling.

Multimodal Lifestyle Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

• Brown JC, Nauta P, Whitehead D, Dubin BR, Nash R, Blumberg K, Green T, Brown J, Compton SLE, Miletello GP. A randomized trial of a multimodal lifestyle intervention in cancer survivors. Front Oncol. 2025 Oct 2;15:1682244. doi: 10.3389/fonc.2025.1682244. eCollection 2025.

  PMID: 41114371 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Justin C Brown, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: August 3, 2021
• Study Start: August 19, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)