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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

No Placebo-Only Group

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 below

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I am mentally capable of following the study's procedures.

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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.

Exclusion Criteria

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

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My breast cancer has spread to other parts of my body.

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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

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

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

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: 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.

0 / 6Eligibility criteria met