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Breast CancerYESNCT04379414

YES Study - Newly Diagnosed/Metastatic Intervention

A study testing YES portal in people with Breast Cancer and Symptom, Behavioral, run by Dana-Farber Cancer Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This research study is being done to monitor common symptoms and behavior, and to provide supportive care information and peer support, as well as research opportunities for young women ages of 18-39 years old who have been diagnosed with stage 0-IV stage breast cancer using a web-based portal (YES), built for… Read more about this study

Who is it for?
Ages 18 to 39 years, women only
Conditions the study is for
Breast Cancer, Symptom, Behavioral
What is being tested?
YES portal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteUnited States
Study dates
16 Sep 2020to 1 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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 IV
  • Female
  • 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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Young, Empowered &Amp; Strong (YES): The Young Women's Breast Cancer Study 2- Focus on Newly Diagnosed/Metastatic Intervention

This research study is being done to monitor common symptoms and behavior, and to provide supportive care information and peer support, as well as research opportunities for young women ages of 18-39 years old who have been diagnosed with stage 0-IV stage breast cancer using a web-based portal (YES), built for smartphones, tablets, and computers.

Read the detailed description

This is a prospective, interventional cohort study with an embedded Phase II randomized controlled clinical trial with a parallel design.

  • The research study procedures include screening for eligibility, consent, enrolled, randomization into 1 of 4 groups.
  • The study interventions including the (web-based portal ) YES portal use including regular assessments, serial outcome surveys, medical record review, and tumor/blood collection.
  • The YES portal is a web-based portal designed for access by smartphone, tablet, or laptop/desktop. The portal is designed to help monitor cancer related issues and to share self-management information and resources to those interested in particular issues or who score high enough on the symptom measures designed to assess and track noticeable symptoms (and thus might benefit from such), as well as to share potential research opportunities when available. The portal is also designed to create a community among participants through the yeschat.org discussion board
  • Participants will be in this research study for up to 5 years with the option to opt out of portal assessment component follow-up after only 1 year.
  • It is expected that about 400 people will take part in this research study
Being tested
YES portal
Keywords
Breast Cancer, Symptom, Behavioral
Medical subject headings
Breast Neoplasms, Behavioral Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YES portalBehavioural

    A web-based portal designed for access by smartphone, tablet, or laptop/desktop. The portal is designed to help monitor cancer related issues and to share self-management information, resources and potential research opportunities. The portal is also designed to create a community among participants through the yeschat.org discussion board.

Study groups in NCT04379414
Study groupRoleWhat they receive
Newly Diagnosed Automatic Symptom InformationExperimentalEligible 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.
Receives: Behavioral: YES portal
Newly Diagnosed Trigger Symptom InformationExperimentalEligible 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.
Receives: Behavioral: YES portal
Metastatic Automatic Symptom InformationExperimentalEligible 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.
Receives: Behavioral: YES portal
Metastatic Trigger Symptom InformationExperimentalEligible 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.
Receives: Behavioral: YES portal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vaginal dryness

    One item regarding vaginal dryness on the BCPT will be used and grouped by moderate, quite a bit, extreme responses to define the vaginal dryness rate at 1 year. Based on historical data (from our ongoing Young Women's Breast Cancer Study), the 1-year vaginal dryness rate for the control group is assumed to be 27%. For the Phase II randomized controlled trial component of the study,it will have 85% power to detect a 10% difference in the primary endpoint with 367 patients, and would plan to recruit 408 to account for dropout (last row of the table).

    Measured: 1 year

Secondary outcomes (13)

  1. Socio-demographics

    Women will be asked about their race, education, employment and financial status using items selected from the Alliance Patient Questionnaire that is currently being piloted (Alliance A191401), adapted to include an item on employment status that has been tested previously in a breast cancer population and is going to be added to the next version of the Alliance Patient Questionnaire.

    Measured: Up to 5 years

  2. Financial burden

    Items adapted from the National Health Interview Survey29 and the Cancer Outcomes Research and Surveillance (CanCORS) Caregiver Study30 will be used to assess financial burden and to estimate out of pocket expenses attributed to their breast cancer diagnosis.

    Measured: Up to 5 years

  3. Smoking and alcohol use

    Smoking and alcohol use will be evaluated using items selected from the prior cohort study of young women with breast cancer and our prior Smoke Free Study

    Measured: Up to 5 years

  4. Physical Activity

    Physical activity will be assessed using a modified version of the Godin Leisure-Time Exercise Questionnaire (GLTEQ).This self-reported measure is used to estimate weekly frequencies of strenuous, moderate, and light activities. It has been modified to include average duration of activities. Weekly minutes of moderate and vigorous activity (MVPA) will be the main measure of physical activity; however weekly minutes of vigorous activity (MVA) and the average weekly frequency of mild, moderate and strenuous intensity exercise based on the Leisure Score Index (LSI) will also be examined to evaluate change in physical activity behaviors. The Godin measure will be administered at multiple timepoints and will be used to evaluate change in physical activity over time.

    Measured: Up to 5 years

  5. Mobility

    The EQ-5D-5L33, 34 is a summary measure of health status for use in evaluating health and healthcare and includes five functional dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) plus a visual analog scale (EQ-VAS) that asks participants to assess how good or bad their health is today on a 0 (worst health imaginable) -100 (best health imaginable) scale. The EQ-5D-5L will be used to generate and evaluate QALYs.

    Measured: Up to 5 years

  6. Self-Care

    The EQ-5D-5L33, 34 is a summary measure of health status for use in evaluating health and healthcare and includes five functional dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) plus a visual analog scale (EQ-VAS) that asks participants to assess how good or bad their health is today on a 0 (worst health imaginable) -100 (best health imaginable) scale. The EQ-5D-5L will be used to generate and evaluate QALYs. T

    Measured: Up to 5 years

  7. Usual Activities

    The EQ-5D-5L33, 34 is a summary measure of health status for use in evaluating health and healthcare and includes five functional dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) plus a visual analog scale (EQ-VAS) that asks participants to assess how good or bad their health is today on a 0 (worst health imaginable) -100 (best health imaginable) scale. The EQ-5D-5L will be used to generate and evaluate QALYs.

    Measured: Up to 5 years

  8. Pain and Discomfort

    The EQ-5D-5L33, 34 is a summary measure of health status for use in evaluating health and healthcare and includes five functional dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) plus a visual analog scale (EQ-VAS) that asks participants to assess how good or bad their health is today on a 0 (worst health imaginable) -100 (best health imaginable) scale.

    Measured: Up to 5 years

  9. Anxiety and Depression

    The Patient Health Questionnaire (PHQ-9)35, 36 will be used to evaluate for clinically significant depression.

    (see management strategy below for the suicidality question in particular). Distress and anxiety will be assessed using select items from the PRO-CTCAE as described below. We will also ask patients to indicate the face that best represents how they feel using a publicly available 5 emoji Likert scale

    Measured: Up to 5 years

  10. Overall Symptoms

    The Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a patient-centered, standardized self-report measure that enables patients to report symptoms and AEs. The PRO-CTCAE has demonstrated favorable validity, reliability, and responsiveness in a large heterogeneous United States sample of cancer patients undergoing treatment.37 40 PRO-CTCAE items that are salient to young women with breast cancer will be collected. The PRO-CTCAE items use conditional branching for AEs that contain multiple attributes. A modified 19-item version of the Breast Cancer Prevention Trial (BCPT) Symptom Checklist will evaluate common symptoms, including hot flashes, fatigue, sexual problems, and musculoskeletal complaints. The PROMIS 8-item Fatigue Scale will be used to assess fatigue. Sleep quality will be evaluated with the Insomnia Severity Index (ISI) as well as with a modified Self-Assessment of Sleep Survey (SASS).

    Measured: Up to 5 years

  11. Adherence to Hormonal or other Oral Therapy

    Measurement of adherence to oral therapy using a 10 item self-report medication adherence measure based on work from Voils et al. among women who report currently prescribed oral hormonal or other oral therapy

    Measured: Up to 5 years

  12. Adolescent and Young Adult (AYA) Concerns

    AYA concerns will be measured by 14 items from the AYA HOPE Study42 follow-up questionnaire that ask patients to rate their level of concern regarding a range of AYA survivorship-focused issues, including fertility, diet and nutrition, physical activity, weight management, survivorship care, recurrence concerns, and financial concerns, and we have added genetics and body image. 3 items have been added to the AYA Concerns that ask about the desire for additional information about select issues facing young women with breast cancer including about body image/beauty, smoking, and alcohol consumption.

    Measured: Up to 5 years

  13. Emotional Symptoms

    Anxiety and depression will be measured by the 14-item Hospital Anxiety and Depression Scale (HADS). This is a reliable and valid instrument that is well received by patients.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2020
  2. Study start16 Sep 2020
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04379414
Sponsor's protocol ID
20-124
Acronym
YES
Status last verified
Dec 2025
First submitted
5 May 2020
Last updated
9 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A study testing YES portal in people with Breast Cancer and Symptom, Behavioral, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vaginal dryness (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04379414.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.

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YES Study - Newly Diagnosed/Metastatic Intervention | AzTrials