Home-Based Exercise for Cancer Patients

Recruiting at 1 trial location

Overseen By Christina M Dieli-Conwright, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Musculoskeletal, Cardiorespiratory, Diabetes, Hypertension, others

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

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

135 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research is to determine whether a 16 week, home-based, aerobic and resistance exercise intervention will increase physical activity levels in Black and Hispanic breast, colorectal, or prostate cancer patients. The names of the study interventions involved in this study are: * Supervised aerobic and resistance exercise (SUP) - virtually supervised 16- week aerobic and resistance exercise performed at home via Zoom. * Unsupervised aerobic and resistance exercise (UNSUP) - home-based 16- week aerobic and resistance exercise. * Attention control (AC) - 16-week home-based stretching.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is home-based exercise safe for cancer patients?

Research suggests that home-based exercise programs, including aerobic and resistance exercises, are generally safe for cancer survivors and may offer physical and psychological benefits. However, the studies emphasize the need for more rigorous research to confirm these findings. ^{1 2 3 4 5}

How does the home-based exercise treatment for cancer patients differ from other treatments?

This treatment is unique because it allows cancer patients to perform aerobic and resistance exercises at home, either supervised or unsupervised, which can improve their quality of life and physical fitness. Unlike traditional supervised programs, this approach offers flexibility and accessibility, making it easier for patients to adhere to their exercise regimen. ^{1 3 4 6 7}

What data supports the effectiveness of the treatment Home-Based Exercise for Cancer Patients?

Research shows that home-based exercise, including aerobic and resistance exercises, can improve the quality of life and physical fitness in cancer survivors. Supervised and personalized programs tend to yield better results, but even unsupervised home-based exercise has shown promising outcomes in improving physical fitness. ^{1 3 4 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 Black and Hispanic adults over 18 with stage I-III breast, colorectal, or prostate cancer who are overweight/obese. They must be starting chemotherapy soon, speak English/Spanish, do less than 90 minutes of exercise per week, and can visit Dana-Farber Cancer Institute for data collection.

Inclusion Criteria

Willing to travel to Dana-Farber Cancer Institute for necessary data collection

I started chemotherapy less than 4 weeks ago.

You are overweight or obese, which means you have too much body fat.

Exclusion Criteria

Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

You are required to do structured exercise for more than 90 minutes per week.

I do not have any uncontrolled illnesses like infections or diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 16-week home-based exercise intervention, including supervised and unsupervised aerobic and resistance exercises, or stretching exercises.

16 weeks

3x weekly at home sessions, 1x weekly telehealth call

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of cardiovascular and metabolic health, physical fitness, and quality of life.

16 weeks

1 post-intervention visit, 1 follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control
• Supervised Home-Based Exercise
• Unsupervised Home-Based Exercise

Trial Overview The THRIVE Study tests if a 16-week home-based exercise program (either supervised via Zoom or unsupervised) improves physical activity in minority cancer patients compared to a control group doing stretching exercises.

How Is the Trial Designed?

Group I: Unsupervised aerobic and resistance exercise (UNSUP) Experimental Treatment 1 Intervention

Participants will be randomly assigned to receive 3x weekly at home, unsupervised aerobic and resistance exercise sessions with a 1x weekly telehealth call with a certified exercise trainer for 16 weeks. Participants will also have a baseline test, mid intervention cardiovascular and strength tests and one postintervention and one follow up visit.

Group II: Supervised aerobic and resistance exercise (SUP) Experimental Treatment 1 Intervention

Participants will be randomly assigned to receive 3x weekly at home, virtually supervised aerobic and resistance exercise sessions with a certified exercise trainer for 16 weeks. Participants will also have a baseline test, mid intervention cardiovascular and strength tests and one postintervention and one follow up visit.

Group III: Attention Control (AC) Active Control 1 Intervention

Participants will be randomly assigned to receive 3x weekly at home stretching exercise for 16 weeks. Participants will also have a baseline test, mid intervention cardiovascular and strength tests and one postintervention and one follow up visit.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

University of Massachusetts, Boston

Collaborator

Trials

42

Recruited

17,800+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A 12-month home-based exercise program for 33 cancer survivors led to significant reductions in waist circumference and improvements in body composition and lower body muscle strength, indicating positive physical changes.

The exercise intervention was found to be safe and cost-effective, with no adverse effects on cardiac function, suggesting that unsupervised exercise can be beneficial for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a home-based exercise rehabilitation program for cancer survivors. Stefani, L., Klika, R., Mascherini, G., et al.[2019]

Only 14.2% of endometrial cancer patients were found to be suitable for unsupervised exercise programs based on their health status at diagnosis, which increased to 20.5% when excluding common comorbidities like hypertension and diabetes.

The study indicates that a significant majority (approximately 80%) of endometrial cancer patients may require referral to medically-supervised exercise programs due to health issues that could hinder their ability to safely engage in unsupervised exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prescription or proscription of exercise in endometrial cancer care. Zhang, X., Haggerty, AF., Brown, JC., et al.[2018]

A study involving 119 cancer patients found that a home-based exercise program did not significantly reduce cancer-related fatigue or related symptoms compared to usual care, indicating that the timing and effectiveness of such interventions need further investigation.

Despite the lack of significant differences in fatigue and related symptoms, the study suggests that any physical activity during cancer treatment is beneficial and poses no harm, highlighting the importance of exercise adherence and regular assessments of patient symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of home-based exercise for cancer-related fatigue in women during and after chemotherapy with or without radiation therapy. Dodd, MJ., Cho, MH., Miaskowski, C., et al.[2022]

A systematic review of 11 studies involving 437 patients with non-small cell lung cancer (NSCLC) found that most rehabilitation programs, particularly those with supervision and personalized training, significantly improved physical fitness.

While home-based rehabilitation showed promise, adherence to exercise varied widely, and more robust studies are needed to fully understand the effectiveness and safety of home-based (pre)rehabilitation for NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of prehabilitation and rehabilitation including a home-based component on physical fitness, adherence, treatment tolerance, and recovery in patients with non-small cell lung cancer: A systematic review. Driessen, EJ., Peeters, ME., Bongers, BC., et al.[2018]

Breast cancer patients participating in a 12-week home-based exercise program showed significant improvements in both the minutes of exercise and the number of steps taken during planned activities, indicating effective adherence to the intervention.

Higher levels of exercise self-efficacy at the start of the program were linked to better adherence outcomes, suggesting that confidence in one's ability to exercise plays a crucial role in maintaining participation over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based exercise among cancer survivors: adherence and its predictors. Pinto, BM., Rabin, C., Dunsiger, S.[2021]

Home-based exercise interventions for cancer survivors show promise in improving cardiorespiratory fitness, physical activity levels, fatigue, health-related quality of life, and body composition, based on a review of nine randomized controlled trials.

Despite the positive findings, the studies had methodological limitations, highlighting the need for more rigorous research designs to better understand the benefits of home-based exercise in cancer rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Aerobic and Resistance Exercise Interventions in Cancer Patients and Survivors: A Systematic Review. Batalik, L., Winnige, P., Dosbaba, F., et al.[2021]

A six-month home-based physical activity intervention for 32 breast cancer survivors resulted in likely modest improvements in cardiorespiratory fitness, with effect sizes indicating beneficial changes in both absolute and relative V̇O2 max.

Participants also reported increased levels of physical activity, suggesting that this intervention could be a practical approach to enhance recovery and fitness in breast cancer survivors post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a home-based physical activity intervention on cardiorespiratory fitness in breast cancer survivors; a randomised controlled trial. Lahart, IM., Carmichael, AR., Nevill, AM., et al.[2018]

A home-based exercise program for breast cancer survivors significantly improved upper body strength and shoulder range of motion after 16 weeks, involving 89 women aged around 55 years.

However, the intervention did not lead to significant changes in overall physical fitness, sedentary behavior, or disability measures, suggesting that additional strategies may be needed to enhance broader health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Home-Based Exercise Intervention in the Fitness Profile of Hispanic Survivors of Breast Cancer. Ortiz, A., Hughes, DC., Mama, SK., et al.[2022]

Citations

1. Italy pubmed.ncbi.nlm.nih.gov

Effects of a home-based exercise rehabilitation program for cancer survivors. [2019]

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

The prescription or proscription of exercise in endometrial cancer care. [2018]

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

A randomized controlled trial of home-based exercise for cancer-related fatigue in women during and after chemotherapy with or without radiation therapy. [2022]

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

Effects of prehabilitation and rehabilitation including a home-based component on physical fitness, adherence, treatment tolerance, and recovery in patients with non-small cell lung cancer: A systematic review. [2018]

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

Home-based exercise among cancer survivors: adherence and its predictors. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Home-Based Aerobic and Resistance Exercise Interventions in Cancer Patients and Survivors: A Systematic Review. [2021]

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

The effects of a home-based physical activity intervention on cardiorespiratory fitness in breast cancer survivors; a randomised controlled trial. [2018]

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

Effectiveness of a Home-Based Exercise Intervention in the Fitness Profile of Hispanic Survivors of Breast Cancer. [2022]