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

Part of paid clinical trials in Miami, Florida.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06623097
Status
Recruiting
Apply to this trial

Conditions

  • Cancer Survivorship

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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

Key Dates

Start date
Jul 23, 2025
Status verified
Jan 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2030

Study Design

Enrollment
1,528 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm 1: Virtually Supervised Care Comparator
    * Complete virtually supervised exercise sessions 3x weekly with their study partner. * Complete Mediterranean eating program coaching session 1x weekly.
  • Experimental: Arm 2: Unsupervised Care
    * 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

Primary Outcome Measure

Change in Global Cognition [ Time Frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33136
Tracy Crane, PhD, RDN
[email protected]
305-243-8255
Loren Yavelberg, PhD
[email protected]
Dana-Farber Cancer InstituteBostonMassachusetts02215
Christina Dieli-Conwright, PhD, MPH
[email protected]
617-632-3800
Christina Dieli-Conwright, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
University of Miami Sylvester Comprehensive Cancer Center· Miami, FLDana-Farber Cancer Institute· Boston, MA

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