Health TrialsbyHealthPanel

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

ConditionCancer Survivorship
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,528 Participants
are divided into 2 treatment groups
Group A: Arm 1: Virtually Supervised Care ComparatorExperimental treatment 1 intervention
Group B: Arm 2: Unsupervised CareExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change 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)
2

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)
3

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)
4

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)

Secondary outcomes

1

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\&#39;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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dana-Farber Cancer Institute

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov
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