Clinical trial NCT05012176: An Episodic Future Thinking Intervention to Promote Weight Loss in Breast Cancer Survivors
Official title: Episodic Future Thinking: An Interventional Pilot Study to Promote Weight Loss in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anatomic Stage 0 Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage IB Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
Anatomic Stage IIIC Breast Cancer AJCC v8
Breast Ductal Carcinoma In Situ
Invasive Breast Carcinoma
Prognostic Stage 0 Breast Cancer AJCC v8
Prognostic Stage I Breast Cancer AJCC v8
Prognostic Stage IA Breast Cancer AJCC v8
Prognostic Stage IB Breast Cancer AJCC v8
Prognostic Stage II Breast Cancer AJCC v8
Prognostic Stage IIA Breast Cancer AJCC v8
Prognostic Stage IIB Breast Cancer AJCC v8
Prognostic Stage III Breast Cancer AJCC v8
Prognostic Stage IIIA Breast Cancer AJCC v8
Prognostic Stage IIIB Breast Cancer AJCC v8
Prognostic Stage IIIC Breast Cancer AJCC v8
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

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

Primary outcomes:
measure: Feasibility measured by Adherence
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Change in total body weight
timeFrame: Up to 12 weeks
measure: Change in total body weight
timeFrame: Up to 24 weeks
measure: Change in delay discounting rate
timeFrame: Baseline to 12 weeks
measure: Change in delay discounting rate
timeFrame: Baseline to 24 weeks
Other outcomes:
measure: Change in patient reported outcome (PRO)
timeFrame: Baseline to 12 weeks
measure: Change in Insulin Resistance
timeFrame: Baseline to 12 weeks
measure: Change in quantity of serum high-sensitivity C-reactive protein
timeFrame: Baseline to 12 weeks
measure: Change in diet quality
timeFrame: Baseline to 12 weeks
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Sagar D Sardesai, MBBS MPH
role: PRINCIPAL_INVESTIGATOR
References: