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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
Willing to provide cell phone number and/or email address, and willing to receive email and/or text messages from the study team either with their own smartphone or one provided by the study team if they do not have their own to use
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

YES Trial 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.Check my eligibility
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.See study design
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.

YES Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mentally capable of following the study's procedures.
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I am willing to share my contact details and receive messages from the study team.
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I was diagnosed with stage 0-III breast cancer between ages 15-39.
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My breast cancer has not come back or spread.
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I have not had any other cancer types since my breast cancer diagnosis, except for non-melanoma skin cancer.
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I am female.
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I was diagnosed with breast cancer within the last 3 years.

YES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 months post-baseline, after the completion of the 6-month active intervention period
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 months post-baseline, after the completion of the 6-month active intervention period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of the Young, Empowered & Strong (YES) intervention in improving quality of life (QOL)
Secondary outcome measures
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 outcome measures
Potential effects of the intervention on inflammatory and other biomarkers and genetic profiles

YES 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
320 Previous Clinical Trials
289,856 Total Patients Enrolled
22 Trials studying Breast Cancer
2,884 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,926,987 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,343 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

Internet-Based Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04906200 — N/A
Breast Cancer Research Study Groups: Group A (YES portal), Group B (usual care)
Breast Cancer Clinical Trial 2023: Internet-Based Intervention Highlights & Side Effects. Trial Name: NCT04906200 — N/A
Internet-Based Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04906200 — N/A

Frequently Asked Questions

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

To whom is enrollment in this trial open?

"This research seeks 360 adolescent and young adult (AYA) women between the ages of 15-39 with a history of stage 0-III breast cancer. Eligible participants must be able to provide contact information, possess sound cognitive abilities, access medical records, have no record of other malignancies since their diagnosis excluding non-melanoma skin cancer, not be pregnant at time of enrollment in study if applicable."

Answered by AI

Is recruitment currently underway for this experiment?

"Affirmative. The information hosted on clinicaltrials.gov indicates that this study is recruiting participants, with the first post dated June 28th 2021 and last edit October 27th 2022. A total of 360 patients need to be enrolled across 3 locations."

Answered by AI

How many participants is the clinical trial currently accepting?

"Affirmative. Clinicaltrials.gov's information affirms that this research initiative, which was first advertised on June 28th 2021, is actively looking for participants. Approximately 360 patients must be recruited from 3 distinct clinical locations."

Answered by AI

Does this research include participants aged 45 or older?

"According to the eligibility requirements, this medical study seeks patients aged between 15 and 39. In comparison, there are 64 trials targeting minors while 2,209 clinical studies are open for enrolment from those over 65 years old."

Answered by AI
~47 spots leftby Aug 2024