Physical Activity Program for Endometrial Cancer Survivors

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Unmanaged lymphedema, Recurrent disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

15 Participants Needed

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment for endometrial cancer survivors?

Research shows that physical activity, including strength training, can improve strength and agility in endometrial cancer survivors, and is associated with better quality of life and potentially lower mortality risk. ^{1 2 3 4 5}

Is physical activity safe for endometrial cancer survivors?

Research suggests that physical activity, including strength training and aerobic exercise, is generally safe for endometrial cancer survivors and can offer health benefits such as improved fitness and reduced risk of cardiovascular disease. ^{1 2 3 6 7}

How does the physical activity treatment for endometrial cancer survivors differ from other treatments?

This treatment is unique because it focuses on home-based aerobic and resistance exercises, which can improve strength, agility, and quality of life without the need for weight loss. Unlike traditional medical treatments, it empowers survivors to engage in physical activity at home, potentially reducing mortality risk and enhancing overall well-being. ^{1 2 3 8 9}

What is the purpose of this trial?

The goal of this research study is to learn if a home-based physical activity program is feasible and can help endometrial cancer survivors lose weight.

Research Team

Karen M. Basen-Engquist

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for Stage I-II endometrial cancer survivors with a BMI of 30-<45, who are 6-36 months post-treatment, over 18 years old, and have access to a phone and internet. Participants must be able to visit the campus twice, speak English, consent to the study, and not be doing much exercise or in another weight loss program.

Inclusion Criteria

Your body mass index (BMI) is between 30 and less than 45 kg/m2.

Diagnosed with Stage I-II endometrial cancer

Six to 36 months post treatment

Exclusion Criteria

You have medical conditions that make it unsafe for you to do exercise at home or follow a low-fat, high fruit and vegetable diet.

Functional limitations requiring a walker/scooter/wheelchair for daily activities

You participate in strength training exercises for at least 30 minutes, on 2 or more days every week.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants complete questionnaires, physical assessments, and provide blood samples

1 week

1 visit (in-person)

Treatment

Participants follow a home-based physical activity program with or without resistance training

6 months

Monthly calls (virtual), ongoing self-monitoring

Midpoint Assessment

Participants complete online questionnaires about physical activity, safety, and quality of life

3 months

Online

Follow-up

Participants are monitored for changes in lean body mass and overall satisfaction with the program

6 months

1 visit (in-person)

Treatment Details

Interventions

• Aerobic Exercise
• Resistance Training

Trial Overview The study tests if a home-based physical activity program can help these survivors lose weight. It includes using an accelerometer (like Fitbit), answering questionnaires, resistance training through video chats, fitness testing, and receiving telephone coaching.

Participant Groups

Group I: NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART) Experimental Treatment 6 Interventions

Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit. Participants placed into an exercise plan focused on physical activity and resistance training. Physical activity guidelines workbook distributed along with activity monitor. Participants receive phone calls and text messages for support in reaching exercise and diet goals. Participants receive resistance bands to perform resistance exercises. Exercise handouts and an iPad mini with training videos used to video chat with a research team member. Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.

Group II: NEXT-Steps- Aerobic Exercise (NS-A) Experimental Treatment 5 Interventions

Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit. Participants placed into an exercise plan focused on physical activity only. Physical activity guidelines workbook distributed along with activity monitor. Participants receive phone calls and text messages for support in reaching exercise and diet goals. Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.

Group III: Standard Care Control Group (CG) Active Control 4 Interventions

Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit. Participants receive standard of care consisting of phone calls asking about their health and self-help materials. Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.

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+

Findings from Research

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 10-week home-based strength training program for 40 post-treatment endometrial cancer survivors resulted in significant improvements in physical function, particularly in chair sit-to-stand, arm curls, and mobility tests.

Despite these functional gains, there were no significant changes in body composition or blood biomarkers, indicating that strength training can enhance physical capabilities without necessarily affecting weight or metabolic markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in strength and agility measures of functional fitness following a telehealth-delivered home-based exercise intervention in endometrial cancer survivors. Gorzelitz, JS., Stoller, S., Costanzo, E., et al.[2023]

In a study of 386 endometrial cancer survivors, those who met public health exercise guidelines and maintained a healthy body weight reported significantly better quality of life (QoL) compared to those who did not, highlighting the importance of physical activity and weight management.

Both exercise and body mass index (BMI) were found to be independently associated with QoL, suggesting that interventions aimed at increasing exercise and reducing excess weight could improve the well-being of endometrial cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations among exercise, body weight, and quality of life in a population-based sample of endometrial cancer survivors. Courneya, KS., Karvinen, KH., Campbell, KL., et al.[2006]

In a study of 425 endometrial cancer survivors over a median follow-up of 14.5 years, higher levels of recreational physical activity after diagnosis were strongly linked to improved overall and disease-free survival, with hazard ratios of 0.33 for both outcomes.

Maintaining high levels of recreational physical activity from before to after diagnosis also correlated with better survival rates, indicating that consistent physical activity may play a crucial role in enhancing outcomes for endometrial cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Cohort Study of Pre- and Postdiagnosis Physical Activity and Endometrial Cancer Survival. Friedenreich, CM., Cook, LS., Wang, Q., et al.[2021]

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]

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]

References

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

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

2. Germany pubmed.ncbi.nlm.nih.gov

Improvements in strength and agility measures of functional fitness following a telehealth-delivered home-based exercise intervention in endometrial cancer survivors. [2023]

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

Mortality risk and physical activity across the lifespan in endometrial cancer survivors. [2022]

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

Associations among exercise, body weight, and quality of life in a population-based sample of endometrial cancer survivors. [2006]

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

Prospective Cohort Study of Pre- and Postdiagnosis Physical Activity and Endometrial Cancer Survival. [2021]

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

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

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

Physical activity and obesity in endometrial cancer survivors: associations with pain, fatigue, and physical functioning. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Change in physical activity and quality of life in endometrial cancer survivors receiving a physical activity intervention. [2020]

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

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