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

NCT06623097 | Recruiting DMC

• 1 other identifier: 23-697
• Study Type: interventional
• Target: 1,528
• Locations: 1 country
• Sites: 2

Brief 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. The names of the study interventions involved in this study are:

• Virtually supervised exercise and healthy diet care
• Unsupervised exercise and healthy diet care

Conditions

Cancer Survivorship

Keywords

Cancer Survivorship

Outcome Measures

Primary Outcomes (11)

• Change in Global Cognition

  The Montreal Cognitive Assessment (MOCA) will also be used to assess global cognition.

  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.

  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.

  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.

  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).

  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).

  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.

  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.

  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.

  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.

  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.

  From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)

Secondary Outcomes (6)

• Accelerometer-Captured Physical Activity

  From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)

• Patient-Reported Outcome: PROMIS-29 Quality of Life Questionnaire

  From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)

• Patient-Report Outcome: PROMIS Cognitive Function Questionnaire

  From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)

• Mediterranean Eating Pattern

  From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)

• Alternate Mediterranean Diet Score (aMED)

  From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)

Study Arms (2)

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.

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

Behavioral: Unsupervised Exercise and Diet Program

Interventions

Unsupervised Exercise and Diet Program BEHAVIORAL

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.

Arm 2: Unsupervised Care

Supervised Exercise and Diet Program BEHAVIORAL

A home-based, virtually supervised, moderate-to-vigorous aerobic and resistance exercise intervention with a certified cancer 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.

Arm 1: Virtually Supervised Care Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute: collaborator
• Dana-Farber Cancer Institute: lead

Study Sites (2)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Study Officials

• Christina Dieli-Conwright, PhD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Dieli-Conwright, PhD, MPH

CONTACT

617-632-3800; christinam_dieli-conwright@dfci.harvard.edu

Jordan Lane, MSc

CONTACT

617-582-7494; jordan_lane@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: July 23, 2025
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2030
• Last Updated: March 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (2)