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YES Portal for Young Breast Cancer Patients (YES Trial)

N/A
Recruiting
Led By Ann H Partridge, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage IV female with initial diagnosis of breast cancer between the ages of 18-39 years, be fluent in and able to read English, have internet access on a regular basis at the time of consent that can support the web-based platform
Stage 0-3 female diagnosed with breast cancer between the ages of 18-39 years, less than 3 months post diagnosis date of new primary or local recurrence (prior history of other cancer is allowed as long as treated with curative intent and no evidence of disease from that cancer), has not started treatment for breast cancer diagnosis yet, is planning to get care at DFCI, be fluent in and able to read English, have internet access on a regular basis at the time of consent that can support the web-based platform
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

YES Trial Summary

This trial is testing a web-based portal for young breast cancer patients to track symptoms, get care info, and connect with peers.

Who is the study for?
The YES Study is for young women aged 18-39 who have been newly diagnosed with stage 0-IV breast cancer. Participants must be fluent in English, have not started treatment yet, and regularly access the internet to use a web-based platform.Check my eligibility
What is being tested?
This study tests a web-based portal called YES designed for smartphones, tablets, and computers. It aims to monitor symptoms and behavior while providing supportive care information, peer support, and research opportunities.See study design
What are the potential side effects?
Since this trial involves using an informational web portal rather than medication or medical procedures, traditional side effects are not applicable. However, users may experience emotional or psychological impacts from the content.

YES Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with stage IV breast cancer between 18-39 years old, speak English, and have regular internet access.
Select...
I am a woman aged 18-39, recently diagnosed with stage 0-3 breast cancer, and have not started treatment.

YES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vaginal dryness
Secondary outcome measures
Adherence to Hormonal or other Oral Therapy
Adolescent and Young Adult (AYA) Concerns
Anxiety and Depression
+10 more

YES Trial Design

4Treatment groups
Experimental Treatment
Group I: Newly Diagnosed Trigger Symptom InformationExperimental Treatment1 Intervention
Eligible participants are consented and enrolled and randomized into 1 or 4 groups in the study. Randomization allocation not shared directly with participant. Participants with early stage breast cancer will respond to baseline (at enrollment) and follow-up outcome surveys via. Participants will then create a personal YES portal account and automatically receive information on sexual health and vaginal dryness. Participants will also complete serial monitoring assessments in the portal. YES portal assessments will be sent once a week for the first 12 weeks (each assessment will take approximately 10-15 minutes). After 12 weeks of weekly assessments in YES portal, the frequency of assessments will be changed to once every month. Surveys will be sent once every 6 months for the first 3 years, then annually. Participants will be asked to allow for medical record review, two blood samples (baseline and 3-6 months), and a sample of any tissue available to bank.
Group II: Newly Diagnosed Automatic Symptom InformationExperimental Treatment1 Intervention
Eligible participants are consented and enrolled and randomized into 1 or 4 groups in the study. Randomization allocation not shared directly with participant. Participants with early stage breast cancer will respond to baseline (at enrollment) and follow-up outcome surveys via. Participants will then create a personal YES portal account and automatically receive information on sexual health and vaginal dryness. Participants will also complete serial monitoring assessments in the portal. YES portal assessments will be sent once a week for the first 12 weeks (each assessment will take approximately 10-15 minutes). After 12 weeks of weekly assessments in YES portal, the frequency of assessments will be changed to once every month. Surveys will be sent once every 6 months for the first 3 years, then annually. Participants will be asked to allow for medical record review, two blood samples (baseline and 3-6 months), and a sample of any tissue available to bank.
Group III: Metastatic Trigger Symptom InformationExperimental Treatment1 Intervention
Eligible participants are consented and enrolled and randomized into 1 or 4 groups in the study. Randomization allocation not shared directly with participant. Participants with early stage breast cancer will respond to baseline (at enrollment) and follow-up outcome surveys via. Participants will then create a personal YES portal account and automatically receive information on sexual health and vaginal dryness. Participants will also complete serial monitoring assessments in the portal. YES portal assessments will be sent once a week for the first 12 weeks (each assessment will take approximately 10-15 minutes). After 12 weeks of weekly assessments in YES portal, the frequency of assessments will be changed to once every month. Surveys will be sent once every 6 months for the first 3 years, then annually. Participants will be asked to allow for medical record review, two blood samples (baseline and 3-6 months), and a sample of any tissue available to bank.
Group IV: Metastatic Automatic Symptom InformationExperimental Treatment1 Intervention
Eligible participants are consented and enrolled and randomized into 1 or 4 groups in the study. Randomization allocation not shared directly with participant. Participants with early stage breast cancer will respond to baseline (at enrollment) and follow-up outcome surveys via. Participants will then create a personal YES portal account and automatically receive information on sexual health and vaginal dryness. Participants will also complete serial monitoring assessments in the portal. YES portal assessments will be sent once a week for the first 12 weeks (each assessment will take approximately 10-15 minutes). After 12 weeks of weekly assessments in YES portal, the frequency of assessments will be changed to once every month. Surveys will be sent once every 6 months for the first 3 years, then annually. Participants will be asked to allow for medical record review, two blood samples (baseline and 3-6 months), and a sample of any tissue available to bank.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
YES portal
2019
N/A
~30

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,473 Total Patients Enrolled
141 Trials studying Breast Cancer
22,217 Patients Enrolled for Breast Cancer
Breast Cancer Research FoundationOTHER
68 Previous Clinical Trials
137,243 Total Patients Enrolled
40 Trials studying Breast Cancer
129,953 Patients Enrolled for Breast Cancer
Ann H Partridge, MDPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

YES portal Clinical Trial Eligibility Overview. Trial Name: NCT04379414 — N/A
Breast Cancer Research Study Groups: Newly Diagnosed Automatic Symptom Information, Newly Diagnosed Trigger Symptom Information, Metastatic Automatic Symptom Information, Metastatic Trigger Symptom Information
Breast Cancer Clinical Trial 2023: YES portal Highlights & Side Effects. Trial Name: NCT04379414 — N/A
YES portal 2023 Treatment Timeline for Medical Study. Trial Name: NCT04379414 — N/A

Frequently Asked Questions

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

Is the age limit for enrolment in this experiment greater than twenty-five?

"Those hoping to participate must be of legal age and below 39 years old."

Answered by AI

Who is capable of taking part in this trial?

"Applicants with breast cancer and between the ages of 18 to 39 are invited to participate in this clinical trial. A maximum of 400 people will be accepted into the study."

Answered by AI

How many individuals are being granted access to this research protocol?

"Affirmative. According to clinicaltrials.gov, the trial that was posted on September 16th 2020 is currently looking for 400 individuals from one single medical facility."

Answered by AI

Does this research offer any opportunities for involvement?

"As per the clinicaltrials.gov registry, this medical study is actively in search of participants with a commencement date on September 16th 2020 and its most recent update occuring July 4th 2022."

Answered by AI
~182 spots leftby Mar 2027