Exercise Program for Breast Cancer Survivors

Not currently recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Herceptin, Non-hormonal cancer treatments

Disqualifiers: Recent myocardial infarction, Unstable angina, others

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

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an exercise program specifically designed for Hispanic breast cancer survivors. Researchers aim to identify the best methods to encourage regular exercise among participants. Participants will receive either culturally adapted exercise materials or standard ones, with progress monitored through regular check-ins and follow-up questionnaires. The trial seeks Mexican-American or Puerto Rican women who have had breast cancer, are not currently meeting exercise guidelines, and live in specific areas of Texas or Puerto Rico. As an unphased trial, participants contribute to valuable research that may enhance exercise programs for breast cancer survivors.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently receiving Herceptin or non-hormonal cancer treatments, but hormonal treatments are allowed.

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

Research shows that personalized exercise programs can be safe and beneficial for breast cancer survivors. Studies have found that these programs reduce tiredness and improve overall well-being. Participants reported less pain and fewer breathing problems. Specifically, one study discovered that three months of customized exercise improved heart health and reduced depression symptoms in breast cancer survivors. Overall, evidence suggests that these exercise programs are well-received and offer several health benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Exercise Program for Breast Cancer Survivors because it offers a personalized approach to improving the quality of life for survivors, which is not commonly addressed by standard cancer treatments like chemotherapy or radiation. This program is unique because it provides individualized exercise plans based on fitness tests and cultural considerations, ensuring that the activities are both effective and relatable for participants. Additionally, the program includes regular follow-ups and materials to keep participants engaged, which could lead to better adherence and more significant long-term health benefits compared to traditional exercise recommendations.

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

Research has shown that exercise programs can greatly benefit breast cancer survivors. In this trial, researchers will divide participants into groups to assess the effectiveness of culturally adapted versus non-culturally adapted exercise materials. One study found that a 12-week home exercise program improved physical fitness in breast cancer patients. Another study demonstrated that survivors became significantly stronger after a three-month exercise program, with benefits persisting a year later. Additionally, combining exercises that enhance heart and lung health with strength training improved survivors' quality of life. Exercise programs have also been linked to reduced physical fatigue and pain. Overall, these findings suggest that exercise plays a crucial role in recovery and enhancing life quality for breast cancer survivors. ^{2 6 7 8 9}

Who Is on the Research Team?

Karen M. Basen-Engquist

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for Hispanic female breast cancer survivors over 21 years old, who are not currently meeting physical activity guidelines and are at least 3 months post treatment. They must be able to consent, read/write in English or Spanish, and live in Harris County, Texas or nearby areas. Those on Herceptin or with conditions that make exercise dangerous can't join.

Inclusion Criteria

Be able to provide informed consent. (Pilot Test and PreTest Criteria)

I am aware of who I am, where I am, and the current time.

I am a woman aged 21 or older.

Exclusion Criteria

I am currently on Herceptin or non-hormonal cancer treatment.

You have recently experienced a heart attack, unstable angina, uncontrolled heart rhythm issues, severe aortic stenosis, uncontrolled heart failure, acute pulmonary embolism or infarction, acute myocarditis or pericarditis, or acute systemic infection with fever and body aches.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants complete fitness testing and questionnaires at the Behavioral Research Treatment Center

1 week

2 visits (in-person)

Treatment

Participants engage in a home-based exercise program for 16 weeks, with monthly group sessions

16 weeks

Monthly group sessions (in-person)

Follow-up

Participants complete follow-up fitness tests and questionnaires, and provide feedback on the program

4 weeks

1 visit (in-person)

Extended Follow-up

Participants complete follow-up questionnaires about physical activity and quality of life

6 months

Questionnaires mailed or given over the phone

What Are the Treatments Tested in This Trial?

Interventions

• Baseline Fitness Test
• Individualized Exercise Program
• Questionnaires
• Written Materials

Trial Overview

The study tests an individualized exercise program tailored for Hispanic breast cancer survivors. It includes a baseline fitness test, questionnaires to track progress, and educational materials aimed at promoting regular exercise habits.

How Is the Trial Designed?

Group I: Non-Cultural Related Material Group Experimental Treatment 4 Interventions

Patients will be randomized to receive either culturally adapted AI materials or non-culturally adapted SI materials. Intervention materials will be mailed to patients every 2 weeks. Based on the results of the fitness tests, a specific exercise program will be presented. The research staff will call about every 2 weeks to check that materials were received and have been sent back whatever materials are due. The phone call should take no more than 15 minutes. At 6 months after the follow-up visit, a packet of follow-up questionnaires about physical activity and quality of life will be mailed or given over the phone. The questionnaire packet will be mailed with a postage-paid return envelope. It should take about 10 minutes to complete the questionnaires.

Group II: Cultural Related Material Group Experimental Treatment 4 Interventions

Patients will be randomized to receive either culturally adapted AI materials or non-culturally adapted SI materials. Intervention materials will be mailed to patients every 2 weeks. Based on the results of the fitness tests, a specific exercise program will be presented. The research staff will call about every 2 weeks to check that materials were received and have been sent back whatever materials are due. The phone call should take no more than 15 minutes. At 6 months after the follow-up visit, a packet of follow-up questionnaires about physical activity and quality of life will be mailed or given over the phone. The questionnaire packet will be mailed with a postage-paid return envelope. It should take about 10 minutes to complete the questionnaires.

Group III: Waitlist Group Active Control 2 Interventions

Patients may choose to participate in the exercise program after 16-week assessment. After 4 months of exercise, all the follow-up tests repeated. Exercise recommendation then given, and all of the intervention materials.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Exercise significantly benefits breast cancer survivors, with recommendations for moderate-intensity aerobic activity 3 to 5 days a week for 20 to 60 minutes, along with resistance training.

Psychological health improves with enjoyable exercise that includes social interaction and skill development, while modifications may be needed for conditions like fatigue or lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for breast cancer survivors: research evidence and clinical guidelines. Courneya, KS., Mackey, JR., McKenzie, DC.[2010]

The study involved 63 breast cancer survivors across 66 group exercise counseling sessions, revealing that while a breast cancer diagnosis creates a common bond, factors like age and expectations can hinder group cohesion.

Key barriers to adherence included feelings of risk for cancer recurrence and people-pleasing behavior, highlighting the need for mental health referrals and effective behavioral modification techniques in group settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned in the trenches: facilitating exercise adherence among breast cancer survivors in a group setting. Rogers, LQ., Vicari, S., Courneya, KS.[2021]

The HEALTh program, a customized cardiac rehabilitation model for female breast cancer survivors, significantly improved cardiorespiratory fitness by 14% and enhanced quality of life and reduced depressive symptoms after 22 sessions.

With a program adherence rate of 66.6%, the study involved 152 breast cancer survivors, demonstrating that structured exercise and education can effectively support physical and mental health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cardiac Rehabilitation Model Improves Fitness, Quality of Life, and Depression in Breast Cancer Survivors. Dolan, LB., Barry, D., Petrella, T., et al.[2019]

The Active Living After Cancer program, designed for breast cancer survivors, effectively improved physical activity levels and quality of life among 127 participants, demonstrating significant enhancements in both mental and physical well-being after 12 weeks of community-based sessions.

Participants showed measurable improvements in physical functioning, with increased sit-to-stand repetitions and longer distances walked in a 6-minute test, indicating that the program successfully promoted better physical capabilities in minority and medically underserved survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active Living After Cancer: Adaptation and evaluation of a community-based physical activity program for minority and medically underserved breast cancer survivors. Tami-Maury, IM., Liao, Y., Rangel, ML., et al.[2022]

In a study involving breast cancer survivors at risk for lymphedema, weightlifting showed a higher rate of musculoskeletal injuries compared to standard care, with injury rates of 2.3 per 1,000 bouts for the weightlifting group.

Despite the efficacy of weightlifting as a rehabilitative exercise, 20.9% of participants required medical attention that led to modifications in their exercise regimen, highlighting the need for well-trained health and fitness professionals to safely implement such programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of weightlifting among women with or at risk for breast cancer-related lymphedema: musculoskeletal injuries and health care use in a weightlifting rehabilitation trial. Brown, JC., Troxel, AB., Schmitz, KH.[2021]

Engaging in at least 3 hours of aerobic exercise per week can significantly improve health outcomes for breast cancer survivors, potentially reducing mortality and morbidity rates.

To help survivors adhere to this exercise regimen, a supportive infrastructure is needed to address common side effects of cancer treatment, such as fatigue and joint pain, and to integrate exercise into their ongoing clinical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for secondary prevention of breast cancer: moving from evidence to changing clinical practice. Schmitz, KH.[2022]

A systematic review of nine randomized controlled trials found that aerobic exercise, often combined with resistance training, significantly improves the quality of life for breast cancer patients and survivors.

The most effective exercise programs typically involved three sessions per week at a moderate intensity (50% to 80% of maximum heart rate) for over 30 minutes, all supervised by a physiotherapist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise parameters in the management of breast cancer: a systematic review of randomized controlled trials. Pastakia, K., Kumar, S.[2022]

A supervised exercise program for breast cancer survivors showed significant improvements in motivational factors related to exercise, particularly in autonomy, with a notable increase in the immediate exercise group compared to the delayed group.

The study involved 60 participants and achieved a 61.3% adherence rate, suggesting that early engagement in exercise can foster a positive attitude towards physical activity, potentially leading to better long-term adherence post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a combined resistance and aerobic exercise program on motivational variables in breast cancer survivors: a randomized controlled trial. Milne, HM., Wallman, KE., Gordon, S., et al.[2018]

Exercise significantly improves quality of life for women with breast cancer, as shown by positive outcomes in 14 randomized controlled trials, despite some variability in results.

In addition to enhancing quality of life, exercise also boosts physical functioning and cardiorespiratory fitness while reducing fatigue symptoms in breast cancer patients and survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise on breast cancer patients and survivors: a systematic review and meta-analysis. McNeely, ML., Campbell, KL., Rowe, BH., et al.[2022]

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