Home-Based Exercise Program for Gynecologic Cancer Survivors

Recruiting at 3 trial locations

Overseen By Zahra Barandouzi, Ph.D., RN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Metastatic cancer, Serious mental health, Muscular-skeletal diseases, Uncontrolled diabetes, others

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

Compensation: Varies

Number of Visits: 25

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a personalized online exercise program can help women who have survived gynecologic cancer improve their quality of life. It examines how exercise affects the gut microbiome (the bacteria living in the digestive system) and reduces symptoms like pain, fatigue, and depression. Participants will use Zoom to follow an exercise plan tailored to their needs and abilities. Women who have completed cancer treatment and find it challenging to meet exercise guidelines may be a good fit.

As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance post-cancer 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. It focuses on an exercise program and does not mention medication changes.

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

Research has shown that home exercise programs are generally safe for cancer survivors. In one study, participants engaged in personalized exercises either in person or through telehealth, and both methods were well-received without major safety issues. Another study found that exercise and physical activity reduced the risk of death and improved the quality of life for cancer survivors. These findings suggest that an online home exercise program is likely safe and beneficial for survivors of gynecologic cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Home-Based Exercise Program for gynecologic cancer survivors because it offers a personalized, flexible approach to rehabilitation. Unlike standard care options that might require in-person visits, this program uses an individualized online format, allowing participants to engage in moderate-intensity exercise from home. This method not only makes it more accessible but also provides ongoing social support via Zoom, which can enhance motivation and adherence. By focusing on functional capacity and incorporating social elements, this program could significantly improve the quality of life for survivors, offering a novel way to support recovery and well-being.

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

Research has shown that personalized exercise programs done at home can improve symptoms and quality of life for cancer survivors. In this trial, participants will engage in an individualized online home-based exercise program. One study found these programs safe and feasible for patients with endometrial cancer. Another study demonstrated that exercise programs conducted through telemedicine can be as effective as traditional methods. A small study also found that endometrial cancer survivors who completed a 12-week home exercise program experienced better well-being and improved quality of life. These findings suggest that home exercise programs might help manage symptoms like pain, fatigue, and depression in women who have had gynecologic cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Zahra A Barandouzi, Ph.D.,MSN,RN

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

This trial is for disadvantaged survivors of gynecologic cancers like ovarian cancer who are experiencing symptoms such as pain, fatigue, sleep issues, depression, and cognitive problems. Participants should have access to an online platform for the exercise program.

Inclusion Criteria

Enrolled in Medicaid (as a factor to determine a low SES)

Do not meet recommended exercise levels as defined by The American College of Sports Medicine

I am a woman aged 18 or older.

Exclusion Criteria

Serious mental health conditions (e.g., bipolar disorder, schizophrenia, major depression)

I had surgery less than 6 weeks ago.

I have had cancer that spread or another type of cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Functional Capacity Assessment

Participants meet with a certified exercise trainer and complete a functional capacity assessment using a treadmill or 6-minute walk test

1 week

1 visit (in-person or virtual)

Treatment

Participants complete an individualized online home-based exercise intervention via Zoom consisting of progressive, moderate-intensity walking and receive social support

12 weeks

24 sessions (virtual, twice a week)

Follow-up

Participants are monitored for changes in psychoneurological symptoms, gut microbiome, and quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Individualized Online Home-Based Exercise Program

Trial Overview The study tests a personalized home-based exercise routine delivered via online platforms aimed at improving gut health and reducing symptoms that affect quality of life in gynecologic cancer survivors with low socioeconomic status (SES).

How Is the Trial Designed?

Group I: Supportive Care (individualized online home-based exercise) Experimental Treatment 5 Interventions

Participants meet with a certified exercise trainer and complete a functional capacity assessment using a treadmill or 6-minute walk test. Participants then complete an individualized online home-based exercise intervention via Zoom consisting of progressive, moderate-intensity walking corresponding to the RPE scale and receive social support over 30 minutes BIW for 12 weeks.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A six-month aerobic exercise program helped ovarian cancer survivors maintain their weight, while those in the control group gained weight, suggesting that exercise may be beneficial for weight management in this population.

However, the study did not find significant changes in body fat percentage, bone mineral density, or lean body mass, indicating that more precise measurement methods may be needed to assess body composition changes effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of exercise on body composition among women with ovarian cancer. Cao, A., Cartmel, B., Li, FY., et al.[2023]

A survey of 239 gynecologic cancer survivors revealed a strong interest in physical activity (PA) programs, indicating a desire for structured support in their recovery.

Interviews with 16 participants emphasized the need for PA counseling that includes information on the benefits, appropriate levels of activity, and available opportunities, highlighting the role of oncology nurses in facilitating these discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The physical activity preferences of gynecologic cancer survivors. Tyrrell, A., Keats, M., Blanchard, C.[2015]

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]

A 12-week physical activity intervention for obese endometrial cancer survivors showed significant improvements in physical function, waist circumference, and quality of life, with large effect sizes compared to a control group.

Despite low recruitment rates, the intervention was feasible, with a majority of participants attending most sessions and reporting increased physical activity, indicating potential for further research in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a physical activity intervention for obese, socioculturally diverse endometrial cancer survivors. Rossi, A., Garber, CE., Ortiz, M., et al.[2017]

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]

Ovarian cancer survivors often experience treatment-related symptoms and comorbidities that negatively impact their physical health, including high rates of overweight and obesity, malnutrition, and low muscle density, which can lead to worse survival outcomes.

There is a significant need for tailored physical activity and exercise interventions for ovarian cancer survivors, as many are insufficiently active or sedentary, but current knowledge gaps hinder the development of specific exercise guidelines for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Physiological Profile of Ovarian Cancer Survivors to Inform Tailored Exercise Interventions and the Development of Exercise Oncology Guidelines. Schofield, C., Newton, RU., Galvão, DA., et al.[2018]

A home-based muscle strengthening program for endometrial cancer survivors was found to be feasible, with 75% of participants adhering to the twice-weekly exercise schedule over 10 weeks and high satisfaction reported.

The program was safe, with no injuries or adverse events reported, indicating that such interventions can be effectively implemented for cancer survivors to promote physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of home-based strength training in endometrial cancer survivors. Gorzelitz, J., Costanzo, E., Gangnon, R., et al.[2023]

This pilot study will assess the feasibility of personalized virtual exercise training for 20 breast and prostate cancer survivors over 24 weeks, which includes 12 weeks of one-on-one training followed by 12 weeks of independent exercise using recorded sessions.

The study aims to evaluate the preliminary effects of this virtual program on various health metrics, such as body composition and exercise self-efficacy, potentially addressing barriers to physical activity in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Streaming Web-Based Exercise at Home Study for Breast and Prostate Cancer Survivors: A Feasibility Study Protocol. Shirazipour, CH., Ruggieri-Bacani, RM., Lockshon, L., et al.[2023]

Exercise interventions for women during or after treatment for gynaecological cancer show significant improvements in physical outcomes such as aerobic capacity, muscular strength, and agility, based on a review of 11 studies including randomized controlled trials and cohort studies.

There was no evidence that exercise worsened any outcomes, suggesting that exercise is a safe and beneficial intervention for this population, although the effects on quality of life and other measures were inconsistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of exercise interventions for women during and after gynaecological cancer treatment - a systematic scoping review. Rose, GL., Stewart, EM., Clifford, BK., et al.[2023]

The 12-week home-based aerobic exercise and nutrition counseling program for obese endometrial cancer survivors showed a high adherence rate of 83.3%, indicating that such interventions can be feasible for this population.

Participants experienced significant reductions in fat mass and BMI, along with improved immune response as indicated by increased T-cell activity, although there were no significant changes in cardiorespiratory fitness or cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Home-Based Exercise and Personalized Nutrition Counseling Intervention in Endometrial Cancer Survivors. Schwartz, AR., Bartlett, DB., Johnson, JL., et al.[2022]

Citations

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An Individualized Online Home-Based Exercise Program ... This clinical trial tests an individualized online home-based exercise program in gynecologic cancer survivors and its impact on gut microbiome (the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9688636/

Feasibility and Effectiveness of the Exercise Program in ... An individualized one-to-one exercise intervention in endometrial cancer patients is feasible in terms of recruitment, adherence and safety.

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Telemedicine-based exercise intervention in cancer survivors This two-armed, non-randomized, controlled intervention study for CS aims to investigate whether a telemedicine-based exercise intervention is as effective as ...

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2021.669961/full

A Pilot Study of Home-Based Exercise and Personalized ... A longitudinal pilot study assessed a 12-week home-based aerobic exercise and nutrition counseling intervention in obese endometrial cancer survivors.

5. ancora.ai ancora.ai/es/details/NCT06709534

An Individualized Online Home-Based Exercise Program ... An individualized online home-based exercise program may be feasible, and may improve symptoms and quality of life in gynecologic cancer survivors. Mostrar ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12346299/

A Secondary Data Analysis - PMC - PubMed Central This study compared the effectiveness of a personalized 12-week exercise program delivered in-person versus via telehealth among cancer ...

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Attitudes, beliefs and preferences surrounding home ... Exercise and physical activity are associated with reduced risk of death, higher quality of life and better functioning in cancer survivors including ...

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Digital home-based post-treatment exercise interventions ... This study aimed to describe existing digital home-based exercises and to assess their effectiveness at improving physical health in female cancer survivors ...

9. withpower.com withpower.com/trial/phase-malignant-female-reproductive-system-neoplasm-11-2024-c155f

Home-Based Exercise Program for Gynecologic Cancer ... This clinical trial tests an individualized online home-based exercise program in gynecologic cancer survivors and its impact on gut microbiome (the ...