An Unsupervised Exercise and Healthy Diet Intervention for the Improvement of Brain and Physical Health in Older Cancer Survivors and their Support Person, Vitality Trial
This clinical trial compares an unsupervised exercise and healthy diet intervention to a supervised exercise and healthy diet intervention for improving brain and physical health in older cancer survivors and their support person. Older adults with cancer are the largest and fastest growing population of cancer survivors. Cancer-related treatment contributes to a large decline in brain and physical health in cancer survivors, which can impact overall health. Support persons are people within the cancer survivors network related by blood or emotional attachment who provide informational, emotional, and/or instrumental support. Support persons can provide involved care activities for an average of 14 months. This can lead them to experience poorer brain and physical health than the general population. Healthy lifestyle behaviors, such as exercise and a healthy diet, can lessen the decline in both brain and physical health. The unsupervised exercise and healthy diet intervention in this study consists of moderate-to-vigorous (moderate-vigorous) aerobic and resistance exercises the individuals complete at home, unsupervised. The individuals also follow healthy diet recommendations that follow the Mediterranean diet eating pattern, which encourages increased fruit and vegetable, whole grain, and healthy fat intake while limiting processed foods and red meat. Participating in an unsupervised exercise and healthy diet intervention may be more effective in improving brain and physical health in older cancer survivors and their support person.
Inclusion Criteria
- CANCER SURVIVORS: Ability to understand and the willingness to sign informed consent prior to any study-related procedures
- CANCER SURVIVORS: 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
- CANCER SURVIVORS: Completed chemotherapy and/or targeted therapy in the previous 36 months; said treatment exposure negatively impacts cognitive and physical function
- CANCER SURVIVORS: 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
- CANCER SURVIVORS: 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
- CANCER SURVIVORS: Overweight/obese: Body mass index (BMI) >= 25 kg/m^2 (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
- CANCER SURVIVORS: 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
- CANCER SURVIVORS: No history of disordered eating; to avoid triggering past eating disorders with a diet intervention program
- CANCER SURVIVORS: 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
- CANCER SURVIVORS: Speak English or Spanish; the study teams will only be able to accommodate for these two languages at this time
- CANCER SURVIVORS: Willing to travel to the respective site for necessary data collection
- SUPPORT PERSONS: Adults >= 18 years of age; the intervention is not designed for adolescent and pediatric populations
- SUPPORT PERSONS: 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
- SUPPORT PERSONS: No history of disordered eating; to avoid triggering past eating disorders with a diet intervention program
- SUPPORT PERSONS: Speak English or Spanish; the study teams will only be able to accommodate for these two languages at this time
Exclusion Criteria
- CANCER SURVIVORS: Adult cancer survivors less than 65 years of age
- CANCER SURVIVORS: Survivors with a TICS score ≤ 22/41
- CANCER SURVIVORS: Survivors with a BMI < 25 kg/m^2 and body fat < 35% for people assigned female at birth and < 25% for people assigned male at birth
- CANCER SURVIVORS: 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
- CANCER SURVIVORS: Have unstable bone lesions. In general patients with severely symptomatic/unstable bone lesions due to bone metastases are at a higher risk of fractures
- CANCER SURVIVORS: 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 Physical Activity Readiness Questionnaire (PAR-Q)
- CANCER SURVIVORS: Subjects with untreated 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
- CANCER SURVIVORS: Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study
- CANCER SURVIVORS: 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
- SUPPORT PERSONS: Support persons less than 18 years of age
- SUPPORT PERSONS: Support persons with a TICS score ≤ 22/41
- SUPPORT PERSONS: 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: 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: Support persons with untreated 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: Support persons receiving treatment for an active malignancy or are < 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06623097.
Locations matching your search criteria
United States
Florida
Aventura
Coral Gables
Coral Springs
Deerfield Beach
Doral
Hollywood
Miami
Plantation
Massachusetts
Boston
PRIMARY OBJECTIVES:
I. Executive function will be measured using the National Institutes of Health (NIH) toolbox. (Cognitive function)
II. Physical function will be assessed using the 6-minute walk test, short physical performance battery (SPPB), timed up and go (TUG), gait speed, sit-to-stand, grip strength, frailty, and muscular strength tests. (Physical function)
SECONDARY OBJECTIVES:
I. Physical activity will be recorded for a week (with a minimum of 4 days) with ActiGraph accelerometer sensor (Fort Walton, FL). (Accelerometer-captured physical activity)
II. Will use the Patient Reported Outcomes Measurement Information System (PROMIS)-29 to assess quality of life and the PROMIS– Cognitive Function – Short Form 4a to measure relevant cognitive function. (Patient-reported outcomes)
III. A trained professional will conduct two interviewer-assisted in-person, telephone, or video-based dietary recalls, aiming for a nonconsecutive weekday and weekend day based on participant availability, using the National Cancer Institute (NCI)-developed Automated Self-Administered 24-hour (ASA24) dietary recall, a web-based tool. (Mediterranean eating pattern)
IV. The Veggie Meter® will be used to noninvasively assess dermal carotenoids as a biomarker of fruit and vegetable intake. (Carotenoid scan)
TERTIARY OBJECTIVES:
I. Process evaluation will be conducted to assess social support, preferences, barriers, self-efficacy, and satisfaction of exercise and diet intervention components from the survivors and support persons. (Theoretical construct measures)
II. Exercise adherence for the virtually supervised group will be assessed based on attendance rate to virtually supervised exercise sessions. (Exercise adherence, virtually supervised group)
III. Diet adherence for the virtually supervised group will be assessed based on attendance rate to virtually supervised nutrition coaching sessions. (Diet adherence, virtually supervised group)
IV. Daily exercise logs completed in the My Wellness Research Platform and response to ‘cue response’ exercise-related text messages. (Exercise adherence, unsupervised group)
V. Daily diet logs completed in the My Wellness Research Platform and response to ‘cue response’ diet-related text messages. (Diet adherence, unsupervised group)
EXPLORATORY OBJECTIVES:
I. Covariates will be assessed by:
Ia. Electronic medical records (EMR) or self-report for sex and ethnicity;
Ib. Body composition;
Ic. Comorbidities.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants attend remote nutrition coaching sessions over 30 minutes once a week (QW) and virtually supervised moderate-vigorous aerobic and resistance exercise sessions over 45-60 minutes three times a week (TIW) for 24 weeks in the absence of unacceptable toxicity. Participants also receive a stationary bicycle, resistance bands, and accelerometer on study. Additionally, participants receive a booklet outlining goals for program maintenance and tips on continuing exercise and the Mediterranean eating pattern during follow-up.
ARM II: Participants follow Mediterranean diet eating pattern recommendations and complete unsupervised moderate-vigorous aerobic and resistance exercise sessions over 45-60 minutes TIW for 24 weeks in the absence of unacceptable toxicity. Participants also view recorded information sessions on the Mediterranean eating pattern and exercise plan QW and receive supportive and engaging text messages four times a week on study. Participants also receive a stationary bicycle, resistance bands, and accelerometer as well as a link to the study website and an intervention booklet on study. Additionally, participants receive a booklet outlining goals for program maintenance and tips on continuing exercise and the Mediterranean eating pattern during follow-up.
After completion of study intervention, participants are followed up at 6 and 12 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorChristina Dieli-Conwright
- Primary ID23-697
- Secondary IDsNCI-2025-05943
- ClinicalTrials.gov IDNCT06623097