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

Trial Summary

What is the purpose of this trial?

This clinical trial evaluates whether a supervised community-based exercise and nutrition program is usable and effective for improving cancer survivors' confidence for maintaining their physical activity and nutrition. Cancer survivors often experience problems with the musculoskeletal system (bones, joints, muscles, connective tissue), the cardiopulmonary system (heart, blood vessels and lungs) and the metabolic system (how the body's cells change food into energy) following treatment. There is substantial evidence that physical activity, diet, and weight management can improve quality of life (emotional and physical well-being) and physical fitness. Information gathered from this study may help researchers determine whether participating in a community-based exercise/nutrition training and education program may improve levels of fitness, cardiovascular health, and quality of life for cancer survivors.

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 data supports the effectiveness of the treatment Community-Based Exercise and Nutrition Training and Education Program for cancer survivors?

Research shows that exercise programs for cancer survivors can improve physical functioning and quality of life. Additionally, combining exercise with nutritional support is emerging as beneficial, suggesting that community-based programs like this one could be effective. ^{1 2 3 4 5}

Is the Exercise and Nutrition Program for Cancer Survivors safe for participants?

Research shows that community-based exercise programs for cancer survivors are generally safe, as clinical trials have demonstrated their safety and benefits for those who have completed cancer treatment. ^{2 3 6 7 8}

How is the Community-Based Exercise and Nutrition Training and Education Program different from other treatments for cancer survivors?

This program is unique because it focuses on improving the health behaviors of cancer survivors through community-based exercise and nutrition education, rather than traditional medical treatments. It emphasizes lifestyle changes, such as increased physical activity and better dietary habits, delivered in group settings to support social interaction and motivation. ^{2 3 7 8 9}

Research Team

Andrew D. Ray

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

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

I am 18 years old or older.

Exclusion Criteria

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

Are pregnant or nursing

I have had a stem cell transplant.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Cancer survivors' experiences of a community-based cancer-specific exercise programme: results of an exploratory survey. [2019]

2. United States 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. [2022]

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

Community-Based Exercise Programs for Cancer Survivors. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

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

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

Community-based exercise program effectiveness and safety for cancer survivors. [2021]

7. England pubmed.ncbi.nlm.nih.gov

CanWell: meeting the psychosocial and exercise needs of cancer survivors by translating evidence into practice. [2015]

8. England 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. [2022]

9. England 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. [2023]