Evaluating the Anticancer Learning Circle Lifestyle Program in Endometrial Cancer Survivors
NCT Number: NCT06550791
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neoplasm, Uterine
Interventions: BEHAVIORAL: Anticancer Learning Circle
Sponsor: University of Virginia
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2025-03

Summary:
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.

Primary Outcome Measures: 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: 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