An Episodic Future Thinking Intervention to Promote Weight Loss in Breast Cancer Survivors
NCT ID: NCT05012176
Last Updated: 2025-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2021-11-01
2023-11-03
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (EFT)
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.
Behavioral Intervention
Participate in EFT
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (ERT)
Patients 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.
Behavioral Intervention
Participate in ERT
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Behavioral Intervention
Participate in EFT
Behavioral Intervention
Participate in ERT
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Sagar Sardesai
Principal Investigator
Principal Investigators
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Sagar D Sardesai, MBBS MPH
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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The Jamesline
Other Identifiers
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NCI-2021-01597
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-20408
Identifier Type: -
Identifier Source: org_study_id
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