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

Trial Summary

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 data supports the effectiveness of the treatment Individualized Online Home-Based Exercise Program for gynecologic cancer survivors?

Research shows that physical activity can improve physical functioning, reduce cancer-related symptoms, and enhance quality of life for cancer survivors. Virtual exercise programs, like the one being studied, can help overcome barriers such as lack of time and reluctance to visit treatment facilities, making it easier for survivors to stay active. ^{1 2 3 4 5}

Is a home-based exercise program safe for cancer survivors?

Home-based exercise programs have been studied in cancer survivors, including those with breast, ovarian, and endometrial cancer, and are generally considered safe. These programs are designed to be feasible and acceptable, promoting long-term health benefits without significant safety concerns. ^{6 7 8 9 10}

How is the Home-Based Exercise Program for Gynecologic Cancer Survivors different from other treatments?

This treatment is unique because it offers a personalized exercise program that can be done at home, which helps overcome barriers like lack of time and reluctance to visit treatment facilities. It focuses on improving physical activity and quality of life for cancer survivors, unlike traditional treatments that may not address these aspects. ^{2 3 6 11 12}

What is the purpose of this trial?

This clinical trial tests an individualized online home-based exercise program in disadvantaged gynecologic cancer survivors and its impact on gut microbiome (the bacteria and microorganisms that live in the digestive system) and symptoms such as pain, fatigue, sleep disturbance, depression, and cognitive impairment. These symptoms can significantly reduce the quality of life (QoL) and survival rate in this cancer population. Thus, promoting physical activity among cancer survivors with low SES may help mitigate these severe symptoms. Using online platforms such as Zoom can help participants access an individualized exercise program that meets their specific needs to engage in physical activity and decrease their symptom burden. Home-based exercise, by providing self-chosen time and location and low costs, can address some barriers to physical activity for cancer survivors with low SES. An individualized online home-based exercise program may be feasible, and may improve symptoms and quality of life in disadvantaged gynecologic cancer survivors.

Research Team

Zahra A Barandouzi, Ph.D., RN

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

References

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

The physical activity preferences of gynecologic cancer survivors. [2015]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Streaming Web-Based Exercise at Home Study for Breast and Prostate Cancer Survivors: A Feasibility Study Protocol. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Perceptions of a comprehensive physical activity behavior intervention among endometrial cancer survivors with obesity. A qualitative study. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of exercise interventions for women during and after gynaecological cancer treatment - a systematic scoping review. [2023]

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

The role of physical activity in breast and gynecologic cancer survivorship. [2018]

6. 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]

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

Effect of exercise on body composition among women with ovarian cancer. [2023]

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]

9. England pubmed.ncbi.nlm.nih.gov

A Physiological Profile of Ovarian Cancer Survivors to Inform Tailored Exercise Interventions and the Development of Exercise Oncology Guidelines. [2018]

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

Feasibility and acceptability of home-based strength training in endometrial cancer survivors. [2023]

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

Feasibility of a physical activity intervention for obese, socioculturally diverse endometrial cancer survivors. [2017]

12. Switzerland pubmed.ncbi.nlm.nih.gov

A Pilot Study of Home-Based Exercise and Personalized Nutrition Counseling Intervention in Endometrial Cancer Survivors. [2022]