Evaluating the Anticancer Learning Circle Lifestyle Program in Endometrial Cancer Survivors

A Prospective Feasibility Study Evaluating the Implementation of the Anticancer Lifestyle Program in Endometrial Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Neoplasm, Uterine
• Intervention / Treatment: Behavioral: Anticancer Learning Circle

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• History of stage I-IV endometrial cancer, any histologic subtype
• Completed cancer treatment, and in surveillance
• Have no evidence of endometrial cancer as determined by primary oncologist
• Be at least 18 years of age
• Be able to read and communicate in English
• Have a smartphone with access to cellular service or computer access with internet service
• 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:

• Pregnant women
• Prisoners
• Subject is blind

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Anticancer Learning Circle Participant

Behavioral: Anticancer Learning Circle; All participants will partake in the Anticancer Learning Circle, a lifestyle modification program. All participants will complete web-based learning modules focused on improving diet, lowering stress, increasing fitness, and reducing exposure to toxins in the home environment. Each week, all participants will meet as a group to discuss the learning topic of the web-based learning module for the week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that complete the program	The proportion of participants completing the program as defined by the number of those who participated in at least 75% of online sessions.	Week 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Week 0 of the Automated Self-administered 24-hour Dietary Assessment (ASA24) at Week 7	The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool is a free, web-based tool created by the National Cancer Institute to assess nutritional intake. ASA24 enables multiple, automatically coded, self-administered 24-hour diet recalls and/or single or multi-day food records, also known as food diaries. Overall nutrition will be assessed at week 0 and week 7 to compare and evaluate changes in dietary patterns of participants.	7 weeks
Change from Week 0 of Generalized Anxiety Disorder (GAD-7) Survey from Baseline at Week 32	The GAD-7 is a validated, self-reported survey assessing feelings of anxiety. Possible scores range from 0 (minimal anxiety) to 21 (severe anxiety). Scores will be evaluated at weeks 0, 4, 7, and 32 with overall primary endpoint evaluating change between week 0 and week 32. Change = (Week 32 Score - Week 0 score)	32 weeks
Change from Week 0 of the Godin Leisure-Time Exercise Questionnaire (GLTEQ) from Baseline at Week 32	The GLTEQ is a validated, self-reported scale assessing physical activity. Participants self-report the number of times per week they engage in strenuous, moderate, and mild/light physical activity. The self-reported number is multiplied by 9 for strenuous exercise, 5 for moderate exercise, and 3 for mild/light exercise. Scores can range from less than 14 units (insufficiently Active/Sedentary) to 24 units of more (Active). Scores will be evaluated at weeks 0, 4, 7, and 32 with overall primary endpoint evaluating change between week 0 and week 32. Change = (Week 32 score - Week 0 score)	32 weeks
Change from Week 0 of the Cancer Worry Scale (CWS) to Week 32	The CWS scale is a validated, self-reported scale assessing participants worries about developing or reoccurring cancer. Scores can range from 8 (seldom or never worried) to 32 (worried a lot/almost all the time). Scores will be evaluated at weeks 0, 4, 7, and 32 with overall primary endpoint evaluating change between week 0 and week 32. Change = (Week 32 score - Week 0 score)	32 weeks
Change from Week 0 of the Patient Health Questionnaire (PHQ-9) to Week 32	The PHQ-9 is a validated, self-reported scale to assess symptoms of major depressive disorder. Scores can range from 0 (none-Minimal) to 27 (severe). Scores will be evaluated at weeks 0, 4, 7, and 32 with overall primary endpoint evaluating change between week 0 and week 32. Change = (Week 32 score - Week 0 score)	Baseline and Week 32
Assess Attitudes Toward Group-Based Lifestyle Therapy Program Utilizing Internal Scale at Week 7 and Week 32	Internal survey built to evaluate participants' satisfaction with the Anticancer Lifestyle Foundation's lifestyle program. Quantitative measures are gathered utilizing a scale of Strongly Disagree to Strongly Agree to assess participant attitudes towards program satisfaction, usefulness of information learned, and to gauge if the participant feels they were able to make positive lifestyle changes through participation in the program. Additional questions assess feelings towards preferences of group size, platform used, number of sessions, and length of program. Qualitive measure allows participants to share any thoughts/concerns/or feedback regarding the program.	Week 7 and Week 32

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Kari Ring, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Actual): March 24, 2025
• Study Completion (Actual): September 28, 2025

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: August 12, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Estimated): October 24, 2025
• Last Update Submitted That Met QC Criteria: October 22, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Endometrial Cancer; Lifestyle Change; Holistic Cancer Treatment
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Endometrial Neoplasms; Uterine Neoplasms
• Other Study ID Numbers: HSR230435

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No