1528 Participants Needed

Exercise and Nutrition for Cancer Survivorship

(VITALITY Trial)

JL
CD
Overseen ByChristina Dieli-Conwright, PhD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Dana-Farber Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Supervised Exercise and Diet Program, Unsupervised Exercise and Diet Program for cancer survivors?

Research shows that combining exercise and a healthy diet can help cancer survivors maintain muscle mass, reduce body fat, and improve overall health. These benefits are seen in both supervised and unsupervised programs, suggesting that such interventions can be effective in improving quality of life and reducing the risk of cancer recurrence.12345

Is the Exercise and Nutrition for Cancer Survivorship program safe for humans?

Research indicates that exercise and nutrition programs for cancer survivors are generally safe and beneficial, improving quality of life and reducing risks of complications. These programs are designed to be individualized and are often supervised by trained professionals to ensure safety.24567

How does the Exercise and Nutrition for Cancer Survivorship treatment differ from other treatments for cancer survivors?

This treatment is unique because it combines supervised and unsupervised exercise with a diet program specifically tailored for cancer survivors, focusing on improving body composition and overall health, which is not a standard approach for this condition.12348

What is the purpose of this trial?

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.The names of the study interventions involved in this study are:* Virtually supervised exercise and healthy diet care* Unsupervised exercise and healthy diet care

Research Team

Christina M. Dieli-Conwright, PhD, MPH ...

Christina M Dieli-Conwright, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for older cancer survivors and their support persons. Participants should be interested in improving cognitive and physical functions through exercise and diet. Specific eligibility details are not provided, but typically include health status requirements.

Inclusion Criteria

Willing to travel to the respective site for necessary data collection
No detection of limiting cognitive impairment as measured by scoring ≥20 on the MoCA; moderate or severe cognitive impairment could impact ability to complete testing and intervention safely
Ability to understand and the willingness to sign informed consent prior to any study-related procedures
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Exclusion Criteria

Support persons with unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise
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
Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants engage in a 6-month home-based exercise and diet intervention, either virtually supervised or unsupervised

6 months
Weekly virtual sessions or self-guided activities

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Periodic assessments (virtual or in-person)

Treatment Details

Interventions

  • Supervised Exercise and Diet Program
  • Unsupervised Exercise and Diet Program
Trial Overview The study compares two home-based programs: one where participants follow an exercise and diet plan with virtual supervision, and another where they do it on their own without supervision. The goal is to see which method better improves mental sharpness and physical ability over six months.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm 2: Unsupervised CareExperimental Treatment1 Intervention
* 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
Group II: Arm 1: Virtually Supervised Care ComparatorExperimental Treatment1 Intervention
* Complete virtually supervised exercise sessions 3x weekly with their study partner. * Complete Mediterranean eating program coaching session 1x weekly.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Findings from Research

The Flinders Living Well Self-Management Program™ (FLW Program) is a feasible and acceptable intervention for Australian cancer survivors, showing promise in maintaining muscle mass and improving exercise capacity during and after treatment.
Participants in the program experienced small but positive changes in body composition and significant improvements in global health status, particularly in those who were post-treatment, suggesting that early implementation during chemotherapy could be beneficial.
A Pilot Study of Self-Management-based Nutrition and Physical Activity Intervention in Cancer Survivors.Miller, M., Zrim, S., Lawn, S., et al.[2018]
The simultaneous stage-matched exercise and diet (SSED) intervention was found to be feasible and well-accepted among 45 breast cancer survivors, with 91% completing the trial and 100% receiving intervention calls.
Participants in the SSED group showed significant improvements in motivational readiness for exercise and diet, as well as better emotional functioning, reduced fatigue, and lower depression compared to the control group.
Randomized pilot test of a simultaneous stage-matched exercise and diet intervention for breast cancer survivors.Kim, SH., Shin, MS., Lee, HS., et al.[2022]
A consensus was reached among 82 stakeholders, including healthcare professionals and consumers, on 24 essential elements for optimal dietary and exercise referral practices for cancer survivors, indicating a strong agreement on their importance (mean rating of 4.28 or higher).
The study highlights the need for future research to implement and evaluate these essential elements to enhance dietary and exercise care for cancer survivors, ensuring that health professionals have clear guidance in their practices.
Essential elements of optimal dietary and exercise referral practices for cancer survivors: expert consensus for medical and nursing health professionals.Joseph, R., Hart, NH., Bradford, N., et al.[2022]

References

A Pilot Study of Self-Management-based Nutrition and Physical Activity Intervention in Cancer Survivors. [2018]
Randomized pilot test of a simultaneous stage-matched exercise and diet intervention for breast cancer survivors. [2022]
A randomized trial of exercise and diet on body composition in survivors of breast cancer with overweight or obesity. [2022]
Essential elements of optimal dietary and exercise referral practices for cancer survivors: expert consensus for medical and nursing health professionals. [2022]
[Nutrition and physical activity (PA) during and after cancer treatment: Therapeutic benefits, pathophysiology, recommendations, clinical management]. [2022]
Examining Contributors to Intent to Continue Exercising in Patients With Cancer in Rehabilitation. [2022]
Design and implementation of a community-based exercise program for breast cancer patients. [2022]
Effect of a diet and physical activity intervention on body weight and nutritional patterns in overweight and obese breast cancer survivors. [2021]
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