Skip to main content
OpenTrials
Completed

NCT Number: NCT05012176

An Episodic Future Thinking Intervention to Promote Weight Loss in Breast Cancer Survivors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8 Adenocarcinoma 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 Carcinoma In Situ Breast Diseases Breast Ductal Carcinoma in Situ Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Invasive Breast Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial 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 Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioral intervention

Behavioral

Participate in EFT

Other names: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Feasibility measured by Adherence

    Time frame: Up to 12 weeks

    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)

Secondary outcomes

  1. Change in total body weight

    Time frame: Up to 12 weeks

    Evaluated using a linear mixed effects model. The model will include baseline measure, timepoint (12 and 24 weeks), treatment assignment, and the timepoint by treatment interaction as fixed effects. A subject-level random effect will be included to account for the correlation of multiple measurements of the same individual.

  2. Change in total body weight

    Time frame: Up to 24 weeks

    Evaluated using a linear mixed effects model. The model will include baseline measure, timepoint (12 and 24 weeks), treatment assignment, and the timepoint by treatment interaction as fixed effects. A subject-level random effect will be included to account for the correlation of multiple measurements of the same individual.

  3. Change in delay discounting rate

    Time frame: Baseline to 12 weeks

    Evaluated using a linear mixed effects model. The model will include baseline measure, timepoint (12 weeks), treatment assignment, and the timepoint by treatment interaction as fixed effects. A subject-level random effect will be included to account for the correlation of multiple measurements of the same individual.

  4. Change in delay discounting rate

    Time frame: Baseline to 24 weeks

    Evaluated using a linear mixed effects model. The model will include baseline measure, timepoint (24 weeks), treatment assignment, and the timepoint by treatment interaction as fixed effects. A subject-level random effect will be included to account for the correlation of multiple measurements of the same individual.

Other outcomes

  1. Change in patient reported outcome (PRO)

    Time frame: Baseline to 12 weeks

    PRO measured by standard instruments: PROMIS® scales 29 Profile v2.1 (domains: physical function, social roles, fatigue, depression, anxiety, pain, sleep disturbance) and Global Health Short Form (general physical and mental health)

  2. Change in Insulin Resistance

    Time frame: Baseline to 12 weeks

    Insulin Resistance will be measured by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

  3. Change in quantity of serum high-sensitivity C-reactive protein

    Time frame: Baseline to 12 weeks

    Inflammatory Biomarker

  4. Change in diet quality

    Time frame: Baseline to 12 weeks

    Measured by Health Eating Index 2015.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Episodic Future Thinking: An Interventional Pilot Study to Promote Weight Loss in Breast Cancer Survivors

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 19, 2021
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.