Actively Recruiting
Exercise and Nutrition for Older Cancer Survivors and Their Support Person: The Vitality Study
Led by Dana-Farber Cancer Institute · Updated on 2026-03-02
1528
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of virtually supervised versus unsupervised home-based exercise and diet programs on cognitive and physical function in older cancer survivors and their support persons. This study focuses on survivors of breast, lung, prostate, or colorectal cancer who have completed chemotherapy or targeted therapy within the past 36 months and are at higher risk for physical and cognitive declines due to age and obesity-related factors. The trial is funded by the Patient Centered Outcomes Research Institute and aims to enroll about 1528 participants. Participants will be randomly assigned to one of two groups: one receiving virtually supervised exercise sessions three times a week along with weekly Mediterranean diet coaching, and the other receiving unsupervised exercise recommendations with educational videos, supportive texts, and access to diet resources. Both groups will use stationary bicycles, resistance bands, activity trackers, and diet tracking tools. The intervention lasts for six months, followed by additional monitoring. Throughout the 12-month participation, individuals will undergo fitness and health evaluations including cognitive tests, physical function assessments (such as the 6-minute walk test and grip strength), diet assessments, surveys, and questionnaires. These measures are taken at baseline, after the 6-month intervention, and at 12 months to assess changes over time. The study also involves safety monitoring and requires participants to attend in-clinic visits and complete various assessments to track their progress.
CONDITIONS
Brief Title
Exercise and Nutrition for Older Cancer Survivors and Their Support Person: The Vitality Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability and willingness to sign informed consent before any study procedures
- Adults aged 65 years or older who survived breast, lung, prostate, or colorectal cancer
- Completed chemotherapy and/or targeted therapy within the last 36 months
- No signs of dementia as measured by a cognitive test (score 23 or higher)
- Overweight or obese with BMI 25 kg/m2 or higher or elevated body fat percentage
- Currently exercising less than 60 minutes per week at moderate or vigorous intensity
- No history of disordered eating
- Living with an informal support person aged 18 or older willing to participate
- Speak English or Spanish
- Willing to travel to study site for data collection
- Support persons must be adults aged 18 or older
- Support persons must have no signs of dementia (score 23 or higher)
- Support persons must have no history of disordered eating
- Support persons must speak English or Spanish
You will not qualify if you...
- Cancer survivors younger than 65 years old
- Cognitive test score 22 or lower indicating possible dementia
- BMI less than 25 kg/m2 or low body fat percentage
- Currently following a Mediterranean diet meeting 2 or more specific goals
- Unstable medical conditions preventing moderate-to-vigorous exercise
- Severe psychiatric conditions such as major depression, bipolar disorder, or active substance use disorder
- Unable to comply with safety monitoring requirements
- Receiving treatment for active cancer except certain exceptions
- Support persons younger than 18 years old
- Support persons who are pregnant or planning pregnancy during the study
- Support persons with unstable medical conditions preventing exercise
- Support persons with severe psychiatric conditions
- Support persons currently receiving active cancer treatment or less than 10 years from cancer treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants engage in either a virtually supervised or unsupervised home-based exercise and diet program, including aerobic and resistance exercises and Mediterranean eating pattern coaching or guidance.
Weekly virtual coaching sessions or instructional videos with regular exercise sessions 3 times per week
Duration - 6 months
Participants are monitored after completing the 6-month intervention to assess cognitive and physical function changes.
Visits at month 12 for assessments
Trial Site Locations
Total: 2 locations
1
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
C
Christina Dieli-Conwright, PhD, MPH
J
Jordan Lane, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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