A Prospective Feasibility Study Evaluating the Implementation of the Anticancer Lifestyle Program in Endometrial Cancer Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Virginia
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Number of participants that complete the program
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of participants that complete the program
Time Frame: Week 7
The proportion of participants completing the program as defined by the number of those who participated in at least 75% of online sessions.
Secondary Outcomes
- Change from Week 0 of the Automated Self-administered 24-hour Dietary Assessment (ASA24) at Week 7(7 weeks)
- Assess Attitudes Toward Group-Based Lifestyle Therapy Program Utilizing Internal Scale at Week 7 and Week 32(Week 7 and Week 32)
- Change from Week 0 of Generalized Anxiety Disorder (GAD-7) Survey from Baseline at Week 32(32 weeks)
- Change from Week 0 of the Godin Leisure-Time Exercise Questionnaire (GLTEQ) from Baseline at Week 32(32 weeks)
- Change from Week 0 of the Cancer Worry Scale (CWS) to Week 32(32 weeks)
- Change from Week 0 of the Patient Health Questionnaire (PHQ-9) to Week 32(Baseline and Week 32)
Investigators
Kari Ring, MD
Assistant Professor
University of Virginia