Home workouts and diet plans aim to sharpen minds and strengthen bodies after cancer
NCT ID NCT06623097
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a 6-month home exercise and nutrition program can improve thinking and physical abilities in cancer survivors aged 65 and older, along with their support person. About 1,500 participants will be assigned to either a virtually supervised or unsupervised program. The goal is to find a practical way to help older survivors stay sharp and active.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 1,528 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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University of Miami Sylvester Comprehensive Cancer Center
RECRUITINGMiami, Florida, 33136, United States
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