Cancer SurvivorshipVITALITYNCT06623097
Exercise and Nutrition for Older Cancer Survivors and Their Support Person: The Vitality Study
A study testing Supervised Exercise and Diet Program and Unsupervised Exercise and Diet Program in people with Cancer Survivorship, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivorship
- What is being tested?
- Supervised Exercise and Diet Program and Unsupervised Exercise and Diet Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,528 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jul 2025to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- Not actively on chemotherapy or radiation; said treatment exposure negatively impacts cognitive and physical function. Eligible patients can still be on maintenance-type therapies (i.e., immunotherapy, hormonal therapy, targeted therapy).
- 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
- 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.
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- No history of disordered eating; to avoid triggering of past eating disorders with a diet intervention program.
- Has an informal support person (>18 years of age) 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.
- 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.
Who cannot join
- Adult cancer survivors less than 65 years of age.
- Survivors with a TICS score ≤ 22/41
- 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.
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- 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 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Christina Dieli-Conwright, PhD, MPH, 617-632-3800, ChristinaM_Dieli-Conwright@dfci.harvard.edu
Christina Dieli-Conwright, PhD
- Recruiting
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Tracy Crane, PhD, RDN, 305-243-8255, tecrane@med.miami.edu
Loren Yavelberg, PhD, l.yavelberg@med.miami.edu
About this study
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
Read the 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
- Being tested
- Supervised Exercise and Diet Program, Unsupervised Exercise and Diet Program
- Keywords
- Cancer Survivorship
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Exercise and Diet ProgramBehavioural
A home-based, virtually supervised, moderate-to-vigorous aerobic and resistance exercise intervention with an 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.
Unsupervised Exercise and Diet ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Virtually Supervised Care Comparator | Experimental | * Complete virtually supervised exercise sessions 3x weekly with their study partner.
* Complete Mediterranean eating program coaching session 1x weekly. Receives: Behavioral: Supervised Exercise and Diet Program |
| Arm 2: Unsupervised Care | Experimental | * Receives exercise and diet intervention recommendations including 3x weekly workouts and healthy eating goals
* Weekly recorded informative videos
* 4x weekly supportive text messages
* Study website access and interventional booklet Receives: Behavioral: Unsupervised Exercise and Diet Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Global Cognition
The Montreal Cognitive Assessment (MOCA) will also be used to assess global cognition.
Measured: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Change in Cognitive Function
Cognitive function will be measured using the National Institutes of Health (NIH) toolbox (www.nihtoolbox.org). Within the NIH toolbox, executive function, immediate recall, memory, attention, working memory, and processing speed will be measured.
Measured: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Change in Physical Function (6-minute walk test)
The 6-minute walk test is also conducted to assess aerobic endurance and capacity. Distance achieved during the 6-minute walk test is recorded in meters.
Measured: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Change Physical Function (Short Physical Performance Battery [SPPB])
The SPPB is comprised of three sections: 1) balance with feet together, semi tandem, and full tandem is held for up to 10 seconds with no support (seconds); 2) usual gait speed over four meters is timed (seconds); and 3) chair stand where the time(s) to complete five chair sit-to-stands is recorded.
Measured: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Change in Physical Function (Timed-Up-And-Go (TUG) Test)
The TUG test times how fast it takes a participant to stand up from a chair, walk around a cone placed three meters away from a chair where they start, and end in a seated position (seconds).
Measured: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Change in Physical Function (Gait Speed)
Gait speed is assessed over a six-meter course with a flat surface, where the time to walk the 15 foot course at a usual and fast pace is recorded (seconds).
Measured: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Change in Physical Function (Sit-to-Stand Test)
The sit-to-stand test involves participants completing as many sit-to-stands from a seated chair position to a standing position with full hip extension in 30 seconds.
Measured: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Change in Physical Function (Grip Strength)
Grip strength is assessed using a hand-held dynamometer on the participant's dominant hand.
Measured: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Change in Physical Function (Frailty)
Overall frailty will be assessed using the Rockwood model, a 42-item questionnaire, and the Fried model, a 5-item questionnaire.
Measured: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Change in Physical Function (Cardiorespiratory Fitness)
Cardiorespiratory fitness will be assessed as VO2peak by a graded maximal bicycle exercise stress test.
Measured: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Change in Physical Function (Muscular Strength)
Muscular strength will be assessed using 1-Repetition Maximum (RM) and will be estimated from 10-RM muscular strength tests.
Measured: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Secondary outcomes (6)
Accelerometer-Captured Physical Activity
Physical activity will be recorded for a week with ActiGraph accelerometer sensor. Physical activity also will be measured by self-report using the modified Godin Leisure-Time Exercise Questionnaire (GLTEQ), a 3-item measure with a score range of less than 14 units to 24 units or more. The higher the weekly total score represents the greater a participant\'s physical activity. The GLTEQ assesses current participation in any structured exercise and asks the participant how much time they spend exercising in a typical 7-day period.
Measured: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Patient-Reported Outcome: PROMIS-29 Quality of Life Questionnaire
Assessed by the PROMIS-29 Profile v2.0 Questionnaire, a 29-item measure graded on a 5 point Likert scale with answers ranging from 5 (without difficulty/never/not at all) to 1 (unable to do/always/very much) with a total score range of 29 to 140 points. A higher score reflects better quality of life.
Measured: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Patient-Report Outcome: PROMIS Cognitive Function Questionnaire
Assessed by the PROMIS- Cognitive Function - Short Form 4a, a 4-item measure graded on a 5-point Likert scale with answers ranging from 5 (never) to 1 (very often) for a total score range of 4 to 20 points. A higher score reflects better cognitive function.
Measured: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Mediterranean Eating Pattern
A trained health coach will conduct virtual or telephone-based dietary recalls of a non-consecutive weekday and weekend day using the NCI-developed Automated Self-Administered 24-hour (ASA24) recall dietary assessment web-based tool. Calorie intake and nutrient density will be averaged over the two days for each time point.
Measured: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Alternate Mediterranean Diet Score (aMED)
The Alternate Mediterranean Diet Score (aMED) will be calculate by comparing an individual's diet to a traditional Mediterranean eating pattern. The total score for the aMED ranges from 0-9, with a higher score indicating greater adherence to aMED dietary pattern.
Measured: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Carotenoid Scan
The Carotenoid Scan will be assessed by a reflection spectroscopy device, Veggie Meter®, to noninvasively assess dermal carotenoids as a biomarker of fruit and vegetable intake. Participants will be instructed to take 3 readings (20 seconds per reading), and an average score will be taken.20 Scores range from 0-800, and higher are associated with fruit and vegetable intake in diverse samples of adults.
Measured: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start23 Jul 2025
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorshipStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute
- Investigators
- Christina Dieli-Conwright, PhD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623097
- Sponsor's protocol ID
- 23-697
- Acronym
- VITALITY
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Nutrition for Older Cancer Survivors and Their Support Person: The Vitality Study
- ClinicalTrials.gov ID
- NCT06623097
- Acronym / sponsor ID
- VITALITY / 23-697
- Conditions
- Cancer Survivorship
- Keywords
- Cancer Survivorship
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,528 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Virtually Supervised Care Comparator | Experimental | Behavioral: Supervised Exercise and Diet Program* Complete virtually supervised exercise sessions 3x weekly with their study partner. * Complete Mediterranean eating program coaching session 1x weekly. |
| Arm 2: Unsupervised Care | Experimental | Behavioral: Unsupervised Exercise and Diet Program* Receives exercise and diet intervention recommendations including 3x weekly workouts and healthy eating goals * Weekly recorded informative videos * 4x weekly supportive text messages * Study website access and interventional booklet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
- 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.
- Not actively on chemotherapy or radiation; said treatment exposure negatively impacts cognitive and physical function. Eligible patients can still be on maintenance-type therapies (i.e., immunotherapy, hormonal therapy, targeted therapy).
- 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
Key exclusion criteria (13 listed)
- Adult cancer survivors less than 65 years of age.
- Survivors with a TICS score ≤ 22/41
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Exercise and Diet ProgramA home-based, virtually supervised, moderate-to-vigorous aerobic and resistance exercise intervention with an 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. | Behavioural | Arm 1: Virtually Supervised Care Comparator |
| Unsupervised Exercise and Diet ProgramA 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. | Behavioural | Arm 2: Unsupervised Care |
Primary outcome
Change in Global Cognition
Time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
The Montreal Cognitive Assessment (MOCA) will also be used to assess global cognition.
Change in Cognitive Function
Time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Cognitive function will be measured using the National Institutes of Health (NIH) toolbox (www.nihtoolbox.org). Within the NIH toolbox, executive function, immediate recall, memory, attention, working memory, and processing speed will be measured.
Change in Physical Function (6-minute walk test)
Time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
The 6-minute walk test is also conducted to assess aerobic endurance and capacity. Distance achieved during the 6-minute walk test is recorded in meters.
Change Physical Function (Short Physical Performance Battery [SPPB])
Time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
The SPPB is comprised of three sections: 1) balance with feet together, semi tandem, and full tandem is held for up to 10 seconds with no support (seconds); 2) usual gait speed over four meters is timed (seconds); and 3) chair stand where the time(s) to complete five chair sit-to-stands is recorded.
Change in Physical Function (Timed-Up-And-Go (TUG) Test)
Time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
The TUG test times how fast it takes a participant to stand up from a chair, walk around a cone placed three meters away from a chair where they start, and end in a seated position (seconds).
Change in Physical Function (Gait Speed)
Time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Gait speed is assessed over a six-meter course with a flat surface, where the time to walk the 15 foot course at a usual and fast pace is recorded (seconds).
Change in Physical Function (Sit-to-Stand Test)
Time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
The sit-to-stand test involves participants completing as many sit-to-stands from a seated chair position to a standing position with full hip extension in 30 seconds.
Change in Physical Function (Grip Strength)
Time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Grip strength is assessed using a hand-held dynamometer on the participant's dominant hand.
Change in Physical Function (Frailty)
Time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Overall frailty will be assessed using the Rockwood model, a 42-item questionnaire, and the Fried model, a 5-item questionnaire.
Change in Physical Function (Cardiorespiratory Fitness)
Time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Cardiorespiratory fitness will be assessed as VO2peak by a graded maximal bicycle exercise stress test.
Change in Physical Function (Muscular Strength)
Time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Muscular strength will be assessed using 1-Repetition Maximum (RM) and will be estimated from 10-RM muscular strength tests.
6 secondary outcomes
Accelerometer-Captured Physical Activity
Time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Patient-Reported Outcome: PROMIS-29 Quality of Life Questionnaire
Time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Patient-Report Outcome: PROMIS Cognitive Function Questionnaire
Time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Mediterranean Eating Pattern
Time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Alternate Mediterranean Diet Score (aMED)
Time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Carotenoid Scan
Time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina Dieli-Conwright, PhD, MPH principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Exercise and Diet Program and Unsupervised Exercise and Diet Program in people with Cancer Survivorship, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Dieli-Conwright, PhD, MPH (617-632-3800, christinam_dieli-conwright@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Global Cognition (time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.