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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
Endocrine and HER2- directed therapy is permitted
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 receiving hormone or HER2-targeted therapy.
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I had breast cancer, completed all treatments over 21 days ago, and am now in recovery.
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I am 18 years old or older.
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I am 18 years old or older.
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I am motivated to lose weight.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility measured by Adherence
Secondary outcome measures
Change in delay discounting rate
Change in total body weight
Other outcome measures
Change in Insulin Resistance
Change in diet quality
Change in patient reported outcome (PRO)
+1 more

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

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
316 Previous Clinical Trials
289,636 Total Patients Enrolled
22 Trials studying Breast Cancer
2,884 Patients Enrolled for Breast Cancer
Sagar D Sardesai, MBBS MPHPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Media Library

Episodic Future thinking Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05012176 — N/A
Breast Cancer Research Study Groups: Arm I (EFT), Arm II (ERT)
Breast Cancer Clinical Trial 2023: Episodic Future thinking Intervention Highlights & Side Effects. Trial Name: NCT05012176 — N/A
Episodic Future thinking Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05012176 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research initiative still accessible to participants?

"Per the information hosted on clinicaltrials.gov, this trial is actively enrolling participants. The project was first advertised on November 1st 2021 and recently updated December 16th of that same year."

Answered by AI

How many participants are being taken into account for the clinical trial?

"Affirmative, clinicaltrials.gov reports that this experiment is presently in search of enrollees and was initially posted on November 1st 2021 with a subsequent refreshment of the data occurring December 16th 2021. The study necessitates 40 individuals at just one medical centre."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Indiana
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~15 spots leftby Mar 2025