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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 belowSelect...
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.
Select...
I am 18 years old or older.
Select...
I am 18 years old or older.
Select...
I am motivated to lose weight.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a body mass index (BMI) of 25 or higher.I am receiving hormone or HER2-targeted therapy.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.I had breast cancer, completed all treatments over 21 days ago, and am now in recovery.I am motivated to lose weight.I am 18 years old or older.You weigh more than what is considered healthy for your height.I am 18 years old or older.I am motivated to lose weight.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (EFT)
- Group 2: Arm II (ERT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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