NCT06623097

Exercise and Nutrition for Older Cancer Survivors and Their Support Person: The Vitality Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,528 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study will compare the impact of virtually supervised and unsupervised home-based exercise and diet programs on cognitive and physical function among cancer survivors and support persons. This study will involve a 6-month home-based virtually supervised or unsupervised exercise and diet intervention. The names of the study interventions involved in this study are: * Virtually supervised exercise and healthy diet care * Unsupervised exercise and healthy diet care

Detailed description

This is a multi-center, parallel arm, comparative effectiveness trial to compare the impact of supervised and unsupervised home-based exercise and diet programs on cognitive function and physical function among cancer survivors and support persons. Participants and support persons in this study will be randomly assigned to one of two groups: Group A: Virtually Supervised Care or Group B: Unsupervised Care. Randomization means a participant is placed into a study group by chance. The research study procedures include screening for eligibility, in-clinic visits, evaluations of fitness, physical health, diet, and cognitive function, surveys, and questionnaires. Participation in this study is expected to last 12 months. It is expected about 1528 people will participate in this research study. Patient Centered Outcomes Research Institute (PCORI) is supporting this research study by providing funding for the study.

Conditions

• Cancer Survivorship

Interventions

Type	Name	Description
BEHAVIORAL	Supervised Exercise and Diet Program	A home-based, virtually supervised, moderate-to-vigorous aerobic and resistance exercise intervention with a certified cancer exercise trainer. The exercise sessions will include aerobic exercise on a stationary bicycle and total-body resistance training using resistance bands. Stationary bicycle, resistance bands, activity tracking watch, and Wi-Fi enabled tablet (if needed) will be provided to participants. Dyads will receive remotely delivered nutrition coaching sessions (via telephone or video conferencing) with a health coach each week. Mediterranean eating pattern goals will be tracked using the journal feature of the My Wellness Research platform website.
BEHAVIORAL	Unsupervised Exercise and Diet Program	A home-based, unsupervised moderate-to-vigorous aerobic and resistance exercise intervention. The exercise sessions will include aerobic exercise on a stationary bicycle and total-body resistance training using resistance bands. Stationary bicycle, resistance bands, activity tracking watch will be provided to participants. Dyads will receive Mediterranean eating pattern goals, with an introductory session conducted by research staff. Diet intake will be tracked using the journal feature My Wellness Research platform website.

Timeline

• Start date: 2025-07-23
• Primary completion: 2029-04-30
• Completion: 2030-04-30
• First posted: 2024-10-02
• Last updated: 2026-03-02

Locations

2 sites across 1 country: United States