Exercise and nutrition program for older cancer survivors and their support person

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

This study will see if a 6-month virtually supervised versus unsupervised home exercise and healthy diet program helps older cancer survivors and their support person improve thinking and physical function.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1528 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dana-Farber Cancer Institute (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Miami, Florida and 1 other locations)
• Trial ID: NCT06623097 on ClinicalTrials.gov

What this trial studies

This multi-center, randomized, parallel-arm comparative effectiveness trial will assign older cancer survivors and a designated support person to either a virtually supervised or an unsupervised 6-month home-based exercise and healthy diet program. Participants will complete screening and in-clinic visits for fitness, physical health, diet assessment, and standardized cognitive testing, along with regular surveys and remote monitoring during the intervention. The study plans to enroll about 1,528 participants and includes follow-up out to 12 months to measure changes in cognitive and physical function.

Who should consider this trial

Good fit: Ideal candidates are cancer survivors aged 65 or older who completed chemotherapy or targeted therapy within the past 36 months, were diagnosed with breast, lung, prostate, or colorectal cancer, can provide informed consent and participate with a support person, and do not have dementia.

Not a fit: People with dementia, those who cannot safely exercise, those without access to the required virtual technology, or those with cancers outside the listed types may not be eligible or likely to benefit.

Why it matters

Potential benefit: If successful, this could offer an accessible home-based approach to help preserve or improve thinking skills and physical function for older cancer survivors.

How similar studies have performed: Prior research shows exercise and dietary interventions can improve physical function and sometimes cognition in older adults and cancer survivors, while fully virtual supervised programs are promising but less extensively tested.

Eligibility criteria

Inclusion Criteria for Survivor Participants:

* Ability to understand and the willingness to sign informed consent prior to any study- related procedures.
* Older adults (≥65 years of age); cancer survivors who are at higher risk for developing comorbid conditions related to physical and cognitive function due to age declines.
* Completed chemotherapy and/or targeted therapy in the previous 36 months; said treatment exposure negatively impacts cognitive and physical function.
* Diagnosed with breast, lung, prostate, or colorectal cancer which are obesity-related cancers with higher risk for developing comorbid conditions related to physical and cognitive function.
* No detection of dementia as measured by scoring ≥ 23/41 on the Telephone Interview for Cognitive Status (TICS); it may be unsafe for individuals with dementia to participate in the intervention, and they may not be able to experience measurable cognitive improvement. Additionally, scores on cognitive measures could reflect task comprehension failure - not actual cognitive ability - as individuals with dementia may not be able to comprehend or follow the test instructions
* Overweight/obese: BMI ≥25 kg/m2 (calculated using height and weight) or body fat \>35% for people assigned female at birth and \>25% for people assigned male at birth (estimated by bioelectrical impedance); higher body weight negatively impacts cognitive and physical function.
* Currently participating in \<60 minutes of structured moderate-to-vigorous exercise per week (determined by screening questionnaire); sedentary cancer survivors have a higher need and are more likely to benefit from exercise exposure.
* No history of disordered eating; to avoid triggering of past eating disorders with a diet intervention program.
* Reside with an (≥18 years of age) informal support person willing to participate; survivor/support person dyads will participate in the trial together per the goals of the trial and finding mechanism.
* Speak English or Spanish; the study teams will only be able to accommodate for these two languages at this time.
* Willing to travel to the respective site for necessary data collection.

Inclusion Criteria for Support Person:

* Adults ≥18 years of age; the intervention is not designed for adolescent and pediatric populations.
* No detection of dementia as measured by scoring ≥ 23/41 on the Telephone Interview for Cognitive Status (TICS); it may be unsafe for individuals with dementia to participate in the intervention, and they may not be able to experience measurable cognitive improvement. Additionally, scores on cognitive measures could reflect task comprehension failure - not actual cognitive ability - as individuals with dementia may not be able to comprehend or follow the test instructions
* No history of disordered eating; to avoid triggering of past eating disorders with a diet intervention program.
* Speak English or Spanish; the study teams will only be able to accommodate for these two languages at this time.

Exclusion Criteria for Survivor Participants:

* Adult cancer survivors less than 65 years of age.
* Survivors with a TICS score ≤ 22/41
* Survivors with a BMI \<25 kg/m2 and body fat \<35% for people assigned female at birth and \<25% for people assigned male at birth.
* Survivors currently consuming a Mediterranean Diet or meeting 2 or more out of the following 3 Mediterranean eating pattern goals in the prior 6 weeks: ≥3 servings of vegetables per day, ≥ 3 servings of beans and legumes per week, or ≥ 1 serving of nuts per day.
* Survivors with unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Persons with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of participant safety, as well as because this study involves remote, home-based exercise where close supervision is not possible, participants with unstable medical conditions will be excluded. This will be evaluated through the PAR- Q.
* Subjects with severe psychiatric conditions such as Active Major Depression, Bipolar Disorder, significant Suicidal ideation, and an active substance use and/or substance abuse disorder; these conditions can 1) adversely affect important cognitive test measures and 2) the ability to complete certain circumscribed interventions in the study.
* Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
* Survivors receiving treatment for an active malignancy (exceptions are treatment for basal cell carcinoma. They may receive long term treatments for their diagnosed breast, lung, prostate or colorectal cancer including hormone therapy). This study is exclusively targeting survivors post-primary cancer treatment.

Exclusion Criteria for Support Person:

* Support persons less than 18 years of age.
* Support persons with a TICS score ≤ 22/41
* Given the age range of support persons include those in childbearing years, people who are pregnant, or plan to become pregnant during study duration will be excluded due to the unknown nature of exercise on developing fetuses.
* Support persons with unstable comorbidities that prevent participation in moderate-to- vigorous intensity exercise. Persons with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of participant safety, as well as because this study involves remote, home-based exercise where close supervision is not possible, participants with unstable medical conditions are excluded.
* Support persons with severe psychiatric conditions such as Active Major Depression, Bipolar Disorder, significant Suicidal ideation, and an active substance use and/or substance abuse disorder; these conditions can 1) adversely affect important cognitive test measures and 2) the ability to complete certain circumscribed interventions in the study.
* Support persons receiving treatment for an active malignancy or are less than 10 years from the completion of any cancer treatment (exceptions are treatment for basal cell carcinoma). This is to preserve the "role" of the cancer survivor in the dyad.

Where this trial is running

Miami, Florida and 1 other locations

• University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States (Recruiting)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Christina Dieli-Conwright, PhD, MPH — Dana-Farber Cancer Institute
• Study coordinator: Christina Dieli-Conwright, PhD, MPH

Conditions Cancer Survivorship