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Behavioral Intervention for Weight Loss in Breast Cancer Survivors

N/A

Waitlist Available

Led By Sagar D Sardesai, MBBS MPH

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years

Be older than 18 years old

Must not have

Have not completed definitive locoregional therapy (surgery +/- radiation therapy)

Cognitive impairment which would interfere with performance of DD task or EFT procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a smartphone intervention that simulates positive events in the future can help breast cancer survivors lose weight by making healthier choices.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a behavioral intervention involving questionnaires and lifestyle changes, there are no direct medical side effects like those from drugs or surgery. However, participants may experience stress or frustration related to changing habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't finished my main local cancer treatment.

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

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My breast cancer is at stage IV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility measured by Adherence

Secondary study objectives

Change in delay discounting rate

Change in total body weight

Other study objectives

Change in Insulin Resistance

Change in diet quality

Change in patient reported outcome (PRO)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (EFT)Experimental Treatment3 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 Control3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Behavioral Intervention

2021

Completed Phase 4

~3740

0 / 4Eligibility criteria met