Lifestyle Program for Endometrial Cancer Survivors

Overseen By Kathryn Dryer, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Virginia

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to promote positive lifestyle change among endometrial cancer survivors by using a group-based intervention. Endometrial cancer survivors are at an increased risk of other health conditions like heart disease, diabetes, and other cancers. The study team at the University of Virginia wants to explore new ways to lower these risks. This study will be evaluating the Anticancer Lifestyle program, which takes a more holistic approach and uses web-based learning modules along with weekly group sessions to discuss each topic of the web-based learning modules.

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 data supports the idea that Lifestyle Program for Endometrial Cancer Survivors is an effective treatment?

The available research shows that the Lifestyle Program for Endometrial Cancer Survivors is effective in helping participants lose weight, improve their eating habits, and increase physical activity. Studies also indicate improvements in quality of life and reductions in depression among participants. These positive changes suggest that the program is beneficial for endometrial cancer survivors, especially those who are overweight or obese. ^{1 2 3 4 5}

What safety data exists for the Lifestyle Program for Endometrial Cancer Survivors?

The provided research does not directly address safety data for the Lifestyle Program for Endometrial Cancer Survivors or its alternative names. However, the studies focus on the feasibility, effectiveness, and potential health benefits of lifestyle interventions, such as diet and exercise, for endometrial cancer survivors. These interventions are generally considered safe and beneficial for improving health outcomes, but specific safety data for the named program is not detailed in the abstracts. ^{2 5 6 7 8}

Is the treatment Anticancer Learning Circle a promising treatment for endometrial cancer survivors?

Yes, the Anticancer Learning Circle is a promising treatment for endometrial cancer survivors. It focuses on promoting a healthy lifestyle, including weight loss, better eating habits, and more physical activity, which can improve their quality of life and reduce health risks. ^{2 4 5 8 9}

Research Team

Kari L. Ring

Principal Investigator

University of Virginia

Eligibility Criteria

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.

Treatment Details

Interventions

• Anticancer Learning Circle (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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 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]

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]

References

1. England 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. [2021]

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

Survivors of uterine cancer empowered by exercise and healthy diet (SUCCEED): a randomized controlled trial. [2022]

3. England 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. [2021]

4. England 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. [2021]

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

Feasibility and effectiveness of a lifestyle intervention program in obese endometrial cancer patients: a randomized trial. [2008]

6. England 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. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Prevention of endometrial cancer through lifestyle Interventions: A systematic review and synthesis. [2022]

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

Mixed-method approach to informing a lifestyle intervention to improve the survivorship of patients with endometrial cancer. [2023]

9. England 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. [2022]