An Episodic Future Thinking Intervention to Promote Weight Loss in Breast Cancer Survivors
Episodic Future Thinking: An Interventional Pilot Study to Promote Weight Loss in Breast Cancer Survivors
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2021
CompletedFirst Posted
Study publicly available on registry
August 19, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2023
CompletedFebruary 7, 2025
February 1, 2025
2 years
July 13, 2021
February 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility measured by Adherence
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)
Up to 12 weeks
Secondary Outcomes (4)
Change in total body weight
Up to 12 weeks
Change in total body weight
Up to 24 weeks
Change in delay discounting rate
Baseline to 12 weeks
Change in delay discounting rate
Baseline to 24 weeks
Other Outcomes (4)
Change in patient reported outcome (PRO)
Baseline to 12 weeks
Change in Insulin Resistance
Baseline to 12 weeks
Change in quantity of serum high-sensitivity C-reactive protein
Baseline to 12 weeks
- +1 more other outcomes
Study Arms (2)
Arm I (EFT)
EXPERIMENTALPatients participate in EFT over 12 weeks, in which they will receive prompts via a guided smartphone application to engage in EFT in their daily lives. Patients are asked to recall future positive experiences to create text cues which vividly describes these experiences.
Arm II (ERT)
ACTIVE COMPARATORPatients participate in ERT over 12 weeks, in which they will receive prompts via a guided smartphone application to engage in ERT in their daily lives. Patients are asked to recall past positive experiences to create text cues which vividly describes these experiences.
Interventions
Participate in EFT
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sagar D Sardesai, MBBS MPH
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 13, 2021
First Posted
August 19, 2021
Study Start
November 1, 2021
Primary Completion
November 3, 2023
Study Completion
November 3, 2023
Last Updated
February 7, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share