Episodic Future Thinking: An Interventional Pilot Study to Promote Weight Loss in Breast Cancer Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Feasibility measured by Adherence
Study Overview
Brief Summary
This clinical trial evaluates the use of an Episodic Future thinking Intervention to promote weight loss in breast cancer survivors. Obesity is associated with multiple negative health sequelae in breast cancer survivors. This includes an increased risk of cancer recurrence and mortality, multiple quality of life issues, and increased risk of co-morbidities.
Delay Discounting is a behavioral health economic target that refers to the "discounting" of a larger benefit in the future for a smaller, more immediate reward in the present. A high delay discounting rate is correlated with poor dietary choices and sedentary lifestyle. Episodic Future Thinking (EFT) simulates positive events that may occur in one's future, engaging the science of prospection. EFT decreases delay discounting rate, resulting in healthier diet choices and weight reduction. However, valuation of the future may impact cancer survivors differently due to adjusted mortality perception and cancer-related stress.
This study will determine the feasibility and preliminary efficacy of remotely delivered (smartphone application) EFT as a behavioral intervention for weight loss in breast cancer survivors. Implementation of EFT as a complementary approach to standard lifestyle interventions could lead to improvement in weight loss, food choice, and quality of life, thereby positively impacting overall health and longevity in cancer survivors.
Detailed Description
PRIMARY OBJECTIVE:
I. To evaluate the feasibility of the 12-week remotely delivered episodic future thinking (EFT) intervention.
SECONDARY OBJECTIVES:
I. To evaluate the impact of EFT compared to control (episodic recent thinking [ERT]) on weight loss and delay discounting (DD) in overweight and obese breast cancer survivors at 12 and 24 weeks.
II. To evaluate the baseline and 12 week change in:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age >= 18 years
- •Breast cancer (BC) survivors (pathologically proven ductal carcinoma in situ or stage I-III invasive BC and completed primary breast surgery, radiation, chemotherapy >= 21 days prior to enrollment)
- •Body mass index (BMI) >= 25 kg/m^2
- •Endocrine and HER2- directed therapy is permitted
- •Have access to a mobile electronic device
- •Motivated to lose weight (readiness to change assessment)
Exclusion Criteria
- •Stage IV BC
- •Have not completed definitive locoregional therapy (surgery +/- radiation therapy)
- •Participating in another weight loss clinical trial
- •Not able to speak and understand English
- •Cognitive impairment which would interfere with performance of DD task or EFT procedures
Outcomes
Primary Outcomes
Feasibility measured by Adherence
Time Frame: Up to 12 weeks
A one-sample t-test will be used to evaluate adherence (average proportion of smartphone prompts participants open and attended to during the 12-week trial recorded by the web application)
Secondary Outcomes
- Change in delay discounting rate(Baseline to 24 weeks)
- Change in total body weight(Up to 24 weeks)
Investigators
Sagar Sardesai
Principal Investigator
Ohio State University Comprehensive Cancer Center