Exercise and Nutrition for Cancer Survivorship

(VITALITY Trial)

Overseen By Christina Dieli-Conwright, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Age, Cognitive impairment, BMI, Psychiatric conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

1528 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 4 5 6 7}

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. ^{1 2 3 4 8}

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

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

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

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

Group I: Arm 2: Unsupervised Care Experimental Treatment 1 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 Comparator Experimental Treatment 1 Intervention

* Complete virtually supervised exercise sessions 3x weekly with their study partner. * Complete Mediterranean eating program coaching session 1x weekly.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Incorporating lifestyle changes, such as diet and physical activity, during and after cancer treatment can significantly improve patients' quality of life and reduce the risk of sarcopenia, which is the loss of muscle mass and strength.

Specifically, a combination of physical activity and the APA-diet can lower the risk of cancer relapse in remission, especially for overweight patients, highlighting the importance of personalized interventions by trained professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nutrition and physical activity (PA) during and after cancer treatment: Therapeutic benefits, pathophysiology, recommendations, clinical management]. Gouez, M., Raynard, B., Marijnen, P., et al.[2022]

The Breast Cancer Patients Engaging in Activity and Undergoing Treatment (BEAUTY) program is a 12-week evidence-based exercise initiative designed to improve the physical and psychological well-being of women undergoing chemotherapy or radiation for breast cancer, offered at no cost to participants.

The program aims to bridge the gap between research on the benefits of exercise for breast cancer recovery and practical community implementation, ensuring safety and adherence while enhancing quality of life for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and implementation of a community-based exercise program for breast cancer patients. Leach, HJ., Danyluk, JM., Culos-Reed, SN.[2022]

A lifestyle intervention involving diet and physical activity led to significant weight loss (5.6 kg) and improvements in body composition among 37 overweight and obese breast cancer survivors who completed the program.

Participants showed substantial reductions in energy and fat intake, along with improvements in quality of life and cardiorespiratory fitness, indicating the intervention's effectiveness in promoting healthier lifestyles post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a diet and physical activity intervention on body weight and nutritional patterns in overweight and obese breast cancer survivors. Travier, N., Fonseca-Nunes, A., Javierre, C., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Pilot Study of Self-Management-based Nutrition and Physical Activity Intervention in Cancer Survivors. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized pilot test of a simultaneous stage-matched exercise and diet intervention for breast cancer survivors. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized trial of exercise and diet on body composition in survivors of breast cancer with overweight or obesity. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Essential elements of optimal dietary and exercise referral practices for cancer survivors: expert consensus for medical and nursing health professionals. [2022]

5. France pubmed.ncbi.nlm.nih.gov

[Nutrition and physical activity (PA) during and after cancer treatment: Therapeutic benefits, pathophysiology, recommendations, clinical management]. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Examining Contributors to Intent to Continue Exercising in Patients With Cancer in Rehabilitation. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Design and implementation of a community-based exercise program for breast cancer patients. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of a diet and physical activity intervention on body weight and nutritional patterns in overweight and obese breast cancer survivors. [2021]