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

Neoplasm Malignant Clinical Trial

— Small Steps  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04987359
• Other study ID #: PBRC 2021-013
• Status: Recruiting
• Phase: N/A
• Start date: August 19, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Pennington Biomedical Research Center
• Contact: Tamara Green
• Phone: 225-763-2733
• Email: Tamara.Green[@]pbrc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Malignant
• Neoplasms

Intervention

Behavioral:
• Multimodal Lifestyle Program
The multimodal lifestyle program will utilize intensive behavioral therapy with structured exercise training and nutritional counseling.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cardiorespiratory fitness capacity (co-primary)	Cardiorespiratory fitness (VO2peak) assessed by a symptom-limited cardiopulmonary exercise test.	Baseline, Week 10
Primary	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	Change in waist Circumference	Measured midway between the lower rib margin and the iliac crest.	Baseline, Week 10
Secondary	Change in fat Mass	Measured by dual-energy x-ray absorptiometry	Baseline, Week 10
Secondary	Change in systolic blood pressure	Seating, resting for 5 minutes before the measure is taken	Baseline, Week 10
Secondary	Change in diastolic blood pressure	Seating, resting for 5 minutes before the measure is taken	Baseline, Week 10
Secondary	Change in medication use	Medications related to cholesterol, diabetes, and blood pressure	Baseline, Week 10
Secondary	Change in physical and mental quality-of-life	Assessed using the 36-Item Short Form Survey (SF-36)	Baseline, Week 10