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Internet-Based Intervention for Young Breast Cancer Survivors (YES Trial)
N/A
Recruiting
Led By Michelle Naughton, PhD
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
Cognitively able to complete the study requirements
Age 15-39 years at diagnosis of a stage 0-III breast cancer
Must not have
Stage IV or metastatic breast cancer
Individuals under age 15 or over age 42
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 months post-baseline, after the completion of the 6-month active intervention period
Awards & highlights
Summary
This trial is testing whether a web-based portal called YES can help manage symptoms in young breast cancer survivors better than standard therapy. The portal helps monitor symptoms and provides useful information and resources.
Who is the study for?
This trial is for young female breast cancer survivors aged 15-39, within 3 years of a stage 0-III diagnosis. They must be free from recurrence or new cancers (except non-melanoma skin cancer), able to understand English, access their medical records, and willing to use email/text for communication.
What is being tested?
The YES portal, a web-based system designed to help monitor symptoms and manage self-care in young breast cancer survivors, is being tested against standard therapy. The goal is to see if it improves quality of life by providing resources and tracking health issues.
What are the potential side effects?
Since the intervention involves using an internet-based portal for symptom monitoring rather than medication or medical procedures, there are no direct physical side effects associated with its use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mentally capable of following the study's procedures.
Select...
I was diagnosed with stage 0-III breast cancer between ages 15-39.
Select...
My breast cancer has not come back or spread.
Select...
I have not had any other cancer types since my breast cancer diagnosis, except for non-melanoma skin cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My breast cancer has spread to other parts of my body.
Select...
I am either younger than 15 or older than 42.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 9 months post-baseline, after the completion of the 6-month active intervention period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 months post-baseline, after the completion of the 6-month active intervention period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy of the Young, Empowered & Strong (YES) intervention in improving quality of life (QOL)
Secondary study objectives
Efficacy of the YES intervention in reducing specific adolescent and young adult (AYA) breast confident (BC) concerns and symptoms at 6-months compared to baseline.
Quality of Life (QOL)
Sustainability of the effects of YES on AYA concerns and symptoms
Other study objectives
Potential effects of the intervention on inflammatory and other biomarkers and genetic profiles
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group A (YES portal)Experimental Treatment2 Interventions
Patients receive access to YES portal for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months.
Group II: Group B (usual care)Active Control2 Interventions
Patients receive usual care for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months. After 9 months, patients may also receive access to YES portal for 3 months.
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
334 Previous Clinical Trials
291,248 Total Patients Enrolled
24 Trials studying Breast Cancer
2,989 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,640 Total Patients Enrolled
945 Trials studying Breast Cancer
1,543,964 Patients Enrolled for Breast Cancer
Michelle Naughton, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
9 Total Patients Enrolled
1 Trials studying Breast Cancer
9 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer has spread to other parts of my body.I am mentally capable of following the study's procedures.I am willing to share my contact details and receive messages from the study team.I was diagnosed with stage 0-III breast cancer between ages 15-39.My breast cancer has not come back or spread.Pregnant people can participate in this study because it's important to consider fertility and pregnancy for young adult cancer survivors.I have not had any other cancer types since my breast cancer diagnosis, except for non-melanoma skin cancer.I am either younger than 15 or older than 42.I am female.I was diagnosed with breast cancer within the last 3 years.I am a young woman with breast cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Group A (YES portal)
- Group 2: Group B (usual care)
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.
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