Exercise and Nutrition Program for Cancer Survivors

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Must not be taking: Steroids

Disqualifiers: Infection, Heart failure, Angina, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a community exercise and nutrition program can help cancer survivors feel more confident about staying active and eating well. It aims to determine if these activities can improve fitness, heart health, and quality of life after cancer treatment. Cancer survivors who have completed their therapy or caregivers of such patients might be suitable for this study. Participants will join a supervised exercise program and receive nutrition education over several weeks.

As an unphased trial, this study provides a unique opportunity for participants to contribute to research that could enhance post-treatment recovery and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently on steroids, you would not be eligible to participate.

What prior data suggests that this exercise and nutrition program is safe for cancer survivors?

Research has shown that exercise and nutrition programs in the community are generally safe for cancer survivors. One study involved 221 survivors participating in these programs at various YMCA locations. The results indicated that the programs were effective and well-tolerated. Participants reported no major negative effects, suggesting these activities are safe for most people.

These programs typically include aerobic and resistance exercises, along with nutrition education, to enhance physical fitness and quality of life. While individual experiences may vary, evidence supports that these supervised activities provide a safe way to improve health after cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it offers a holistic approach to cancer recovery by combining exercise and nutrition, which are not typically the focus of standard treatments like chemotherapy and radiation. This program is unique because it is community-based, allowing cancer survivors to engage in supervised exercise and nutrition education in a supportive environment, which can enhance adherence and motivation. By including both aerobic and resistance exercises along with personalized nutrition training, this approach aims to improve overall health and quality of life for survivors, potentially reducing the risk of cancer recurrence. Additionally, the use of activity trackers provides real-time feedback, helping participants stay engaged and track their progress effectively.

What evidence suggests that this exercise and nutrition program is effective for cancer survivors?

Studies have shown that community exercise programs can greatly improve the quality of life for cancer survivors. Participants have reported feeling healthier overall, experiencing less body pain, and having more energy. Research also shows that these programs can enhance heart health, which is crucial for survivors with heart and lung issues. Additionally, combining exercise with good nutrition can boost physical fitness and emotional well-being. This trial will evaluate a structured exercise and nutrition program designed to help cancer survivors lead a healthier lifestyle. ^{1 3 6 7 8}

Who Is on the Research Team?

Andrew D. Ray

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for cancer survivors who have completed treatment and are looking to improve their physical activity, nutrition, and overall quality of life. Specific eligibility criteria details were not provided.

Inclusion Criteria

I had cancer before and have finished all my treatments.

Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related interventions

Exclusion Criteria

Are pregnant or nursing

I have a condition like arthritis that stops me from exercising.

I have had a stem cell transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a supervised community-based exercise program with aerobic and resistance exercises twice a week for 12 weeks, and receive nutrition education and training once a week for 10 weeks.

12 weeks

2 visits per week (in-person) for exercise, 1 visit per week (in-person) for nutrition education

Follow-up

Participants are monitored for changes in exercise self-efficacy, functional performance, and quality of life after the intervention.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Community-Based Exercise and Nutrition Training and Education Program

Trial Overview The study tests a community-based program combining exercise and nutritional education aimed at boosting fitness, heart health, and well-being in cancer survivors. It involves physical performance testing, medical device assessments, exercise routines, dietary plans, and questionnaires.

How Is the Trial Designed?

Group I: Supportive Care (exercise/nutrition program) Experimental Treatment 5 Interventions

Patients participate in a supervised, community-based exercise program consisting of aerobic and resistance exercise over 45-60 minutes BIW for 12 weeks. Beginning at week 2, patients also receive nutrition education and training QW for 10 weeks. Patients also wear an activity tracker throughout the study.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Published Research Related to This Trial

The ENRICH study is a randomized controlled trial involving adult cancer survivors and their carers, aiming to improve physical activity and dietary behaviors through a structured lifestyle intervention consisting of six group sessions over eight weeks.

The intervention, co-facilitated by an exercise physiologist and dietician, includes education on healthy eating and a home-based exercise program, with outcomes measured through pedometry and self-reported health metrics, highlighting its potential to enhance health behaviors in cancer survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and nutrition routine improving cancer health (ENRICH): the protocol for a randomized efficacy trial of a nutrition and physical activity program for adult cancer survivors and carers. James, EL., Stacey, F., Chapman, K., et al.[2022]

Community-based exercise programs for cancer survivors have been shown to significantly improve quality of life, reduce fatigue, and enhance overall well-being.

Engaging in regular physical activity may also lower the risk of recurrence for certain cancers, such as breast and colon cancer, highlighting the importance of exercise in cancer recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Based Exercise Programs for Cancer Survivors. Musanti, R., Murley, B.[2018]

Exercise programs significantly improve various health indicators in adult cancer patients after completing their main treatment, particularly in areas like muscle strength, fatigue, depression, and quality of life, based on a review of 34 studies.

Patients with breast cancer showed notable benefits from aerobic exercise, with improvements in physical functions such as a 29-meter increase in 6-minute walk distance, highlighting the efficacy of exercise in enhancing recovery and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise programs for patients with cancer improve physical functioning and quality of life. McClellan, R.[2013]

Participants in a cancer-specific community exercise program reported higher self-reported exercise levels compared to before their diagnosis, indicating that such programs can effectively encourage physical activity during treatment.

The program provided significant physical, psychological, and social benefits, with many participants expressing intentions to continue or increase their exercise levels, highlighting the importance of community support in cancer recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer survivors' experiences of a community-based cancer-specific exercise programme: results of an exploratory survey. Catt, S., Sheward, J., Sheward, E., et al.[2019]

A systematic review of 58 publications identified 34 exercise programs for cancer survivors conducted in home or community settings, highlighting the diversity of interventions available.

The review revealed significant gaps in reporting on the implementation processes and contextual factors affecting these programs, indicating a need for more detailed studies to enhance future community-based exercise interventions for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Based Exercise Programs for Cancer Survivors: A Scoping Review of Program Characteristics Using the Consolidated Framework for Implementation Research. Neil-Sztramko, SE., Smith-Turchyn, J., Fong, A., et al.[2022]

The CanWell program, a 12-week community-based exercise and education initiative for cancer survivors, led to significant improvements in health-related quality of life and physical fitness, as evidenced by enhanced performance in a 6-minute walk test and treadmill exercise protocol.

Importantly, the program was safe, with no reported increases in disease burden or exercise-related injuries among participants, highlighting its potential as a standard care practice for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CanWell: meeting the psychosocial and exercise needs of cancer survivors by translating evidence into practice. Cheifetz, O., Park Dorsay, J., Hladysh, G., et al.[2015]

Exercise and physical activity are crucial for cancer survivors, as they help combat reduced physical function and improve overall health during and after treatment.

Combining aerobic and resistance training is especially beneficial for patients experiencing cachexia, and emerging evidence suggests that nutritional support alongside exercise can enhance these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and exercise training in cancer patients. Maddocks, M.[2021]

The AMPLIFI study is testing web-based diet and exercise interventions for middle-aged and older cancer survivors, focusing on improving health behaviors and reducing obesity-related risks through three randomized controlled trials involving multiple behavior change strategies.

The study will assess the efficacy of sequential versus simultaneous interventions over a 2-year period, measuring various health outcomes such as body mass index, physical activity, and muscle mass, using remote technologies for recruitment and assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) cancer survivor health: program project protocols for remote lifestyle intervention and assessment in 3 inter-related randomized controlled trials among survivors of obesity-related cancers. Pekmezi, D., Fontaine, K., Rogers, LQ., et al.[2023]

A community-based exercise program for cancer survivors, involving 221 participants over 12 weeks, showed significant improvements in physical health, including lower blood pressure, increased strength, and better flexibility.

Participants also reported enhanced quality of life, reduced fatigue, and fewer musculoskeletal symptoms, with very few injuries, indicating that such programs are both effective and safe for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based exercise program effectiveness and safety for cancer survivors. Rajotte, EJ., Yi, JC., Baker, KS., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4821160/

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), ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0003999321013484

Community-Based Exercise Programs for Cancer Survivors Evidence from randomized controlled trials conducted within research settings has shown the efficacy of exercise in reducing fatigue, improving cardiovascular ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-06518

Community-Based Exercise and Nutrition Training ... This clinical trial evaluates whether a supervised community-based exercise and nutrition program is usable and effective for improving cancer survivors' ...

4. roswellpark.org roswellpark.org/clinical-trials/list/5517

Community-Based Exercise and Nutrition Training ... This clinical trial evaluates whether a supervised community-based exercise and nutrition program is usable and effective for improving cancer survivors' ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT131388

Effectiveness trial of a community-based supervised ... Conclusions: A community-based exercise program of just 3 months in duration resulted in significant and sustained improvements in the physical, mental and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06565260

Community-Based Exercise and Nutrition Training ... To assess the feasibility and acceptability of a 12-week supervised community-based exercise/nutrition training and education program for cancer survivors.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22246463/

Community-based exercise program effectiveness and safety ... Community-based exercise program effectiveness and safety for cancer ... Results: Data were collected from 221 survivors from 13 YMCA sites and 36 separate ...

8. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21719

American Cancer Society nutrition and physical activity ... The overall 5-year relative survival rate for all cancers combined is now 68%, and there are over 16.9 million survivors in the United ...