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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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This study is evaluating whether a web-based portal can help young women with breast cancer.
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Vaginal dryness
Secondary study objectives
Adherence to Hormonal or other Oral Therapy
Adolescent and Young Adult (AYA) Concerns
Anxiety and Depression
+10 moreTrial 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for breast cancer include chemotherapy, hormone therapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cancer cells, hormone therapy blocks hormones like estrogen that fuel certain types of breast cancer, targeted therapy attacks specific molecules involved in cancer growth, and immunotherapy boosts the body's immune system to fight cancer.
Understanding these mechanisms is crucial for breast cancer patients as it helps them comprehend how their treatment works, manage side effects, and engage in informed discussions with their healthcare providers. Additionally, supportive care and peer support, as provided in the YES study, can enhance treatment adherence and improve overall quality of life by addressing emotional and psychological needs.
Effects of web-based interventions on cancer patients' symptoms: review of randomized trials.Illness stories on the internet: what do breast cancer patients want at the end of treatment?Use of the internet to obtain cancer information among cancer patients at an urban county hospital.
Effects of web-based interventions on cancer patients' symptoms: review of randomized trials.Illness stories on the internet: what do breast cancer patients want at the end of treatment?Use of the internet to obtain cancer information among cancer patients at an urban county hospital.
Find a Location
Who is running the clinical trial?
Breast Cancer Research FoundationOTHER
70 Previous Clinical Trials
137,361 Total Patients Enrolled
41 Trials studying Breast Cancer
130,077 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,100 Previous Clinical Trials
352,697 Total Patients Enrolled
144 Trials studying Breast Cancer
21,612 Patients Enrolled for Breast Cancer
Ann H Partridge, MDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with stage IV breast cancer between 18-39 years old, speak English, and have regular internet access.I am a woman aged 18-39, recently diagnosed with stage 0-3 breast cancer, and have not started treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Metastatic Trigger Symptom Information
- Group 2: Newly Diagnosed Automatic Symptom Information
- Group 3: Newly Diagnosed Trigger Symptom Information
- Group 4: Metastatic Automatic Symptom Information
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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