Breast Cancer Clinical Trial
An Episodic Future Thinking Intervention to Promote Weight Loss in Breast Cancer Survivors
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.
Full 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:
IIa. Patient reported outcomes (PROs) measured by standard instruments: Patient Reported Outcomes Measurement Information System (PROMIS) scales 29 Profile version (v)2.1 (domains: physical function, social roles, fatigue, depression, anxiety, pain, sleep disturbance) and Global Health Short Form (general physical and mental health).
IIb. Insulin resistance (Homeostatic Model Assessment of Insulin Resistance [HOMA-IR]) and high-sensitivity C-reactive protein (hsCRP).
IIc. Diet quality, measured by Health Eating Index (HEI)-2015 on Vioscreen food frequency questionnaire (FFQ).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients 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: Patients participate in Episodic Recent Thinking (ERT; control arm) over 12 weeks, in which they will receive prompts via a guided smartphone application to engage in control thinking in their daily lives. Patients are asked to recall past positive experiences to create text cues which vividly describes these experiences.
After completion of study intervention, patients are followed up for an additional12 weeks.
Eligibility Criteria
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
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There is 1 Location for this study
Columbus Ohio, 43210, United States More Info
Principal Investigator
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