Behavioral Intervention for Weight Loss in Breast Cancer Survivors

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Stage IV BC, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Sagar D Sardesai, MBBS MPH

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors who are overweight (BMI >= 25), over the age of 18, have finished their main treatments at least 21 days ago, and want to lose weight. They must be able to use a mobile device and understand English. Those with stage IV cancer or involved in another weight loss study can't join.

Inclusion Criteria

You have a body mass index (BMI) of 25 or higher.

I am receiving hormone or HER2-targeted therapy.

I had breast cancer, completed all treatments over 21 days ago, and am now in recovery.

Exclusion Criteria

I haven't finished my main local cancer treatment.

I do not have any cognitive issues that would prevent me from completing specific tasks or procedures.

My breast cancer is at stage IV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in either Episodic Future Thinking (EFT) or Episodic Recent Thinking (ERT) intervention over 12 weeks using a guided smartphone application

12 weeks

Remote engagement via smartphone application

Follow-up

Participants are monitored for changes in weight, delay discounting, and other health outcomes after the intervention

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Episodic Future thinking Intervention

Trial Overview The trial tests an Episodic Future Thinking (EFT) intervention delivered via smartphone app aimed at helping breast cancer survivors make healthier diet choices and lose weight by focusing on future positive events rather than immediate rewards.

How Is the Trial Designed?

Group I: Arm I (EFT) Experimental Treatment 3 Interventions

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.

Group II: Arm II (ERT) Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+