Exercise and Nutrition for Cancer Survivorship

(VITALITY Trial)

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different exercise and diet programs can improve mental and physical health in cancer survivors. Participants will either join a virtually supervised exercise and diet program or follow a self-guided plan at home. The trial aims to determine which approach better enhances cognitive and physical function. It suits older adults who have survived breast, lung, prostate, or colorectal cancer, completed treatment in the last year, and currently lead a sedentary lifestyle. Participants should also have a supportive person to join them in the study.

As an unphased trial, it offers a unique opportunity for participants to contribute to research that could enhance the quality of life for cancer survivors.

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 prior data suggests that these exercise and diet programs are safe for cancer survivors?

Research has shown that both guided and self-directed exercise and diet programs can be safe for cancer survivors. Studies have found that the guided program can enhance overall health and quality of life. Participants reported experiencing less pain and fatigue, common issues for cancer survivors.

For the self-directed program, evidence indicates that exercising at home is generally safe and feasible. Minor side effects are the most common issues, suggesting the program is well-tolerated.

Both methods are under study to assess their impact on physical and mental abilities. Current research supports their safety, making them a promising option for cancer survivors seeking to improve their health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these cancer survivorship programs because they emphasize a holistic approach, combining regular exercise and nutrition guidance, which is a shift from the traditional focus on medication and surgical interventions. The virtually supervised care arm offers personalized support through live virtual exercise sessions and weekly coaching on the Mediterranean diet, potentially enhancing adherence and motivation. Meanwhile, the unsupervised care arm provides flexibility and autonomy with recorded videos, supportive text messages, and comprehensive resources, making it easier for survivors to integrate healthy habits into daily life. These programs aim to empower cancer survivors with sustainable lifestyle changes, which could lead to improved overall well-being and long-term health outcomes.

What evidence suggests that this trial's exercise and diet programs could be effective for cancer survivors?

Research has shown that regular exercise and good nutrition greatly benefit cancer survivors. One study found that those who followed a regular exercise program had an 80% chance of remaining cancer-free for five years, compared to 74% for those who only received health education materials. Exercise has also been proven to reduce fatigue and enhance overall well-being. In this trial, participants will join either a virtually supervised exercise and diet program or an unsupervised program. Even without supervision, exercise programs can increase physical activity and aid in weight loss, though results may vary. Overall, both supervised and unsupervised exercise programs have shown promise in improving health for cancer survivors. ^{1 3 6 7 8}

Who Is on the Research Team?

Christina M Dieli-Conwright, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

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2. asco.org asco.org/about-asco/press-center/news-releases/movement-medicine-structured-exercise-program-challenge

Structured Exercise Program May Lower Risk of Cancer ... At five years, the disease-free survival rate was 80% in the structured exercise program and 74% in the health education materials group.

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Exercise and Nutrition for Older Cancer Survivors ... This research study will compare the impact of virtually supervised and unsupervised home-based exercise and diet programs on cognitive and physical ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388914001008

Effects of supervised exercise on motivational outcomes in ... To date, the longest follow-up of motivational outcomes following a supervised exercise trial among cancer survivors is 6 months (Courneya et al., 2012, Milne ...

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Supervised, structured and individualized exercise in ... Our results indicate that the exercise intervention not only had a positive effect on physical fatigue and HRQOL but also on pain and dyspnea.

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Community-based exercise program effectiveness and ... Participants reported improvements in overall health-related quality of life (P< 0.001), social support (P=0.019), body pain (P=0.016), fatigue (P<0.001), ...

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Effects of a prescribed, supervised exercise programme on ... Conclusion. Supervised exercise programmes have the potential to significantly improve outcomes in cancer patients due to an effect on tumour progression.

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Exercise Changes Cancer Survivors Lives for the Better Current research shows that regular exercise improves health outcomes and decreases the risk of cancer returning for cancer survivors. Sylvester ...