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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1,528
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.
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.
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGChange in Global Cognition
The Montreal Cognitive Assessment (MOCA) will also be used to assess global cognition.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)