This clinical trial evaluates the use of an episodic future thinking intervention to promote weight loss in breast cancer survivors. Obesity may negatively impact multiple quality of life factors in breast cancer survivors, including chronic fatigue, sexual dysfunction, body image, lymphedema, and neuropathy. Obesity may also be associated with chronic inflammation and higher inflammatory biomarkers, which may increase the risk of breast cancer. An episodic future thinking intervention may help breast cancer survivors lose weight and improve overall health.
Additional locations may be listed on ClinicalTrials.gov for NCT05012176.
See trial information on ClinicalTrials.gov for a list of participating sites.
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 guided by a clinical research coordinator to create a text cue which vividly describes these experiences.
ARM II: 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 guided by a clinical research coordinator to create a text cue which vividly describes these experiences.
After completion of study intervention, patients are followed up for 12 weeks.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorSagar D. Sardesai
