Lifestyle Program for Endometrial Cancer Survivors

Overseen By Kathryn Dryer, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Pregnancy, Prisoners, Blindness

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

Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

23 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to help endometrial cancer survivors lead healthier lives through a group-based program called the Anticancer Learning Circle. Participants will use web-based learning modules and join weekly group sessions to discuss ways to reduce the risk of other health issues like heart disease and diabetes. The program emphasizes holistic lifestyle changes. This trial is for individuals who have completed their cancer treatment, are in surveillance, and show no current evidence of cancer. Participants need a smartphone or computer with internet access and should be comfortable using these devices.

As an unphased trial, this study offers a unique opportunity to explore lifestyle changes that could enhance well-being after cancer treatment.

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

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on lifestyle changes rather than medication changes.

What prior data suggests that the Anticancer Learning Circle is safe for endometrial cancer survivors?

Research has shown that the Anticancer Learning Circle is a comprehensive lifestyle program for endometrial cancer survivors. This program encourages healthy lifestyle changes through online learning and group discussions.

Specific information on side effects or safety concerns is not available because this is not a medical treatment but a lifestyle change. However, past research on similar programs suggests they are generally safe and well-received by participants. These programs typically include activities like dietary changes, exercise, and stress management, which are safe for most people.

Prospective participants should consult their doctor to ensure the program suits their health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Anticancer Learning Circle is unique because it focuses on lifestyle changes rather than medication or surgery, which are typical treatments for endometrial cancer survivors. Researchers are excited about this approach because it empowers patients with knowledge and support, potentially improving their quality of life and long-term health. Unlike traditional treatments that directly target cancer cells, this program aims to harness the power of community and education to promote healthier living and reduce the risk of cancer recurrence.

What evidence suggests that the Anticancer Learning Circle is effective for endometrial cancer survivors?

Studies have shown that endometrial cancer survivors often face risks such as heart disease, diabetes, and other cancers. In this trial, participants will engage in the Anticancer Lifestyle program, designed to lower these risks through healthy lifestyle changes. Research indicates that these changes can enhance overall health and quality of life for survivors. More than 70% of survivors remain overweight, which can worsen health outcomes. The program provides online learning and group sessions to help participants develop healthier habits. This approach may lead to better long-term health by supporting participants in adopting and maintaining a healthier lifestyle. ^{1 2 3 5 6}

Who Is on the Research Team?

Kari L. Ring

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for endometrial cancer survivors over 18, with no current evidence of cancer. Participants must be able to read and communicate in English, have access to a smartphone or computer with internet, and be willing to follow the study procedures for its duration.

Inclusion Criteria

Be able to read and communicate in English

Must have technological competency/proficiency to use their Smartphone and/or computer, as self-reported by potential subject

Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria

Prisoners

Pregnant women

I am legally blind.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Anticancer Lifestyle program, which includes web-based learning modules and weekly group sessions

7 weeks

Weekly group sessions (virtual)

Follow-up

Participants are monitored for changes in cancer worry, anxiety, dietary patterns, and physical activity

32 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Anticancer Learning Circle

Trial Overview The Anticancer Learning Circle Lifestyle Program is being tested. It's a holistic approach that combines web-based learning modules with weekly group discussions aimed at promoting healthier lifestyles among endometrial cancer survivors.

How Is the Trial Designed?

Group I: Anticancer Learning Circle Participant Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

A 6-month lifestyle intervention program for obese endometrial cancer survivors led to a significant weight loss of 3.5 kg, while the control group experienced a weight gain of 1.4 kg, demonstrating the program's efficacy in promoting weight management.

Participants in the intervention group also showed a notable increase in physical activity, as measured by the Leisure Score Index, with an improvement of 16.4 compared to a decline in the control group, indicating positive changes in lifestyle behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and effectiveness of a lifestyle intervention program in obese endometrial cancer patients: a randomized trial. von Gruenigen, VE., Courneya, KS., Gibbons, HE., et al.[2008]

The pilot trial involving 60 endometrial cancer survivors demonstrated that a behavioral lifestyle program, 'Shape-Up following cancer treatment', was feasible, with 77% adherence and no reported adverse events, indicating safety in the intervention.

Despite the feasibility of the trial, recruitment was challenging, with inconvenience being the main barrier for 78% of eligible survivors who declined participation, suggesting that future studies need to address convenience to improve participation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruitment, adherence, and retention of endometrial cancer survivors in a behavioural lifestyle programme: the Diet and Exercise in Uterine Cancer Survivors (DEUS) parallel randomised pilot trial. Koutoukidis, DA., Beeken, RJ., Manchanda, R., et al.[2022]

An 8-week behavioral lifestyle intervention for endometrial cancer survivors led to significant improvements in dietary habits compared to usual care, with a notable increase in the Alternative Healthy Eating Index score.

Participants in the intervention group reported improved quality of life at the 24-week follow-up, with no adverse events related to the intervention, suggesting it is a safe and beneficial approach for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet, physical activity, and health-related outcomes of endometrial cancer survivors in a behavioral lifestyle program: the Diet and Exercise in Uterine Cancer Survivors (DEUS) parallel randomized controlled pilot trial. Koutoukidis, DA., Beeken, RJ., Manchanda, R., et al.[2021]

A 6-month lifestyle intervention for overweight and obese endometrial cancer survivors resulted in a significant weight loss of approximately 4.6 kg compared to usual care, demonstrating the efficacy of structured lifestyle changes.

Participants in the intervention also increased their physical activity and improved their diet by consuming more fruits and vegetables, indicating that behavior change is achievable in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivors of uterine cancer empowered by exercise and healthy diet (SUCCEED): a randomized controlled trial. von Gruenigen, V., Frasure, H., Kavanagh, MB., et al.[2022]

This pilot clinical trial involves 64 adult endometrial cancer survivors and aims to test an 8-week group-based behavior change program focused on healthy eating and physical activity, compared to usual care.

The study will assess the feasibility of the program by measuring recruitment, adherence, and retention rates, which will help inform a larger trial to evaluate its effectiveness in improving health and quality of life for these survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial. Koutoukidis, DA., Beeken, RJ., Manchanda, R., et al.[2022]

A systematic approach was used to adapt a behavior change program specifically for endometrial cancer survivors, involving 16 participants in focus groups to ensure the intervention met their needs.

The program includes eight group sessions focused on improving healthy eating and physical activity, addressing unique challenges faced by survivors, and has been evaluated through a randomized controlled trial, indicating a structured method for enhancing lifestyle behaviors in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of intervention mapping to adapt a health behavior change intervention for endometrial cancer survivors: the shape-up following cancer treatment program. Koutoukidis, DA., Lopes, S., Atkins, L., et al.[2021]

A study involving 70 endometrial cancer survivors revealed that common barriers to participating in lifestyle interventions included time constraints, resource costs, and doubts about maintaining weight loss, while facilitators included the chance to connect with other survivors and a focus on health rather than just weight loss.

Post-COVID-19, 67% of survivors reported worsening physical activity, dietary choices, and mental health, highlighting the need for targeted interventions to improve their overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mixed-method approach to informing a lifestyle intervention to improve the survivorship of patients with endometrial cancer. Armbruster, SD., Brow, K., Locklear, T., et al.[2023]

A systematic review of nine studies found that lifestyle interventions, including diet and physical activity, as well as surgical weight loss and hormonal treatments, can positively impact biomarkers related to endometrial cancer risk.

These interventions were associated with reduced endometrial proliferation and changes in hormone levels, suggesting potential strategies for lowering the risk of endometrial cancer, although more research is needed in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of endometrial cancer through lifestyle Interventions: A systematic review and synthesis. Rundle-Thiele, D., Shrestha, S., Janda, M.[2022]

A 6-month lifestyle intervention for overweight and obese endometrial cancer survivors improved self-efficacy related to social pressure and restraint, indicating positive changes in their confidence to manage eating behaviors.

While the intervention did not significantly affect overall quality of life or depression levels, weight loss during the study was associated with improvements in emotional well-being and self-efficacy related to negative emotions and physical discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of a lifestyle intervention in obese endometrial cancer survivors: quality of life outcomes and mediators of behavior change. von Gruenigen, VE., Gibbons, HE., Kavanagh, MB., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06550791

Evaluating the Anticancer Learning Circle Lifestyle ... The purpose of this study is to promote positive lifestyle change among endometrial cancer survivors by using a group-based intervention. Endometrial cancer ...

2. ctv.veeva.com ctv.veeva.com/study/evaluating-the-anticancer-learning-circle-lifestyle-program-in-endometrial-cancer-survivors

Evaluating the Anticancer Learning Circle Lifestyle Program in ... The purpose of this study is to promote positive lifestyle change among endometrial cancer survivors by using a group-based intervention. Endometrial cancer ...

3. clin.larvol.com clin.larvol.com/trial-detail/NCT06550791

Evaluating the Anticancer Learning Circle Lifestyle ... Evaluating the Anticancer Learning Circle Lifestyle Program in Endometrial Cancer Survivors ... Download Trial Data.

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-08790

Anticancer Lifestyle Program to Promote Positive ... The Anticancer Lifestyle program may improve survivorship and quality of life in patients with a history of endometrial cancer. Eligibility Criteria ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10977604/

Mixed-method approach to informing a lifestyle intervention ... After diagnosis and treatment, over 70% of endometrial cancer survivors (ECS) remain overweight or obese resulting in poorer clinical outcomes and increased ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4915365/

The Prescription or Proscription of Exercise in Endometrial ... Our study found 14.2%-20.5% of endometrial cancer patients can be safely prescribed community/home based unsupervised exercise at the dose ...