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

Not Applicable

Not yet recruiting

• Conditions: Cancer Survivorship
• Interventions: Behavioral: Supervised Exercise and Diet Program; Behavioral: Unsupervised Exercise and Diet Program

• Registration Number: NCT06623097
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

This research study will compare the impact of virtually supervised and unsupervised home-based exercise and diet programs on cognitive function 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.
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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.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-30
• Study First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-09-30
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02
• Study Start: 2025-03
• Primary Completion: 2029-04-30
• Study Completion: 2030-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1528

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Virtually Supervised Care Comparator	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	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

Primary Outcome Measures

Name	Time	Method
Change in Global Cognition	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	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)	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])	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)	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)	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)	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)	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)	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)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Accelerometer-Captured Physical Activity	From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)	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\&#...
Patient-Reported Outcome: PROMIS-29 Quality of Life Questionnaire	From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)	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.
Patient-Report Outcome: PROMIS Cognitive Function Questionnaire	From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)	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.
Mediterranean Eating Pattern	From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)	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.
Alternate Mediterranean Diet Score (aMED)	From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)	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.
Carotenoid Scan	From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)	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 v...

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States