YES Portal for Young Breast Cancer Patients

(YES Trial)

Overseen By Ann H Partridge, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Male, Over 39, No internet, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is evaluating whether a web-based portal can help young women with breast cancer.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on monitoring symptoms and providing support, so it's likely you can continue your medications, but please confirm with the trial coordinators.

How does the YES Portal treatment differ from other treatments for young breast cancer patients?

The YES Portal is unique because it focuses on providing a comprehensive online support hub for young breast cancer patients, addressing their need for credible information, emotional support, and practical resources, which are often lacking in existing online supports. ^{1 2 3 4 5}

What data supports the effectiveness of the YES portal treatment for young breast cancer patients?

The research suggests that computer-based support systems can improve the quality of life for younger women with breast cancer, which may indicate that the YES portal could be beneficial in providing support and empowerment to young patients. ^{4 6 7 8 9}

Who Is on the Research Team?

Ann Partridge, M.D.

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a woman aged 18-39, recently diagnosed with stage 0-3 breast cancer, and have not started treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Randomization

Participants are consented, enrolled, and randomized into 1 of 4 groups

1 week

Initial Assessment

Participants complete baseline assessments and create a YES portal account

12 weeks

Weekly assessments via YES portal

Ongoing Monitoring

Participants receive monthly assessments and biannual surveys

3 years

Monthly assessments via YES portal, biannual surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Annual surveys

What Are the Treatments Tested in This Trial?

Interventions

• YES portal

Trial Overview 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.

How Is the Trial Designed?

Group I: Newly Diagnosed Trigger Symptom Information Experimental Treatment 1 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 Information Experimental Treatment 1 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 Information Experimental Treatment 1 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 Information Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Breast Cancer Research Foundation

Collaborator

Trials

79

Recruited

40,500+

Published Research Related to This Trial

A study analyzing data from young women with early-stage breast cancer identified six key prognostic factors—race, tumor location, grade, lymph node status, tumor subtype, and size—that significantly impact cancer-specific survival.

Researchers developed a predictive nomogram that accurately estimates 3- and 5-year cancer-specific survival probabilities for this group, demonstrating strong validation with a concordance index of 0.783, which can aid clinicians in making informed treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer-Specific Survival Outcome in Early-Stage Young Breast Cancer: Evidence From the SEER Database Analysis. Liu, R., Xiao, Z., Hu, D., et al.[2022]

In a study of 331 breast cancer cases in Morocco, 24.8% were diagnosed in women aged 40 or younger, highlighting a concerning trend of breast cancer in young women in developing countries.

The study found that young patients often present with aggressive disease characteristics, including advanced stages and high-grade tumors, leading to a 5-year overall survival rate of 75.6%, which indicates a poorer prognosis compared to older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinicopathologic and prognostic features of breast cancer in young women: a series from North of Morocco. Bakkach, J., Mansouri, M., Derkaoui, T., et al.[2018]

The PARADIGM initiative aims to develop a prognostic classifier specifically for young breast cancer patients (aged ≤40 years) to reduce unnecessary overtreatment, as current tools do not adequately reflect their prognosis.

The study will analyze tumor samples from 3525 young patients diagnosed between 1989 and 2000, using advanced techniques like next-generation sequencing to identify gene expression differences that could inform treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term prognosis of young breast cancer patients (≤40 years) who did not receive adjuvant systemic treatment: protocol for the PARADIGM initiative cohort study. Dackus, GM., Ter Hoeve, ND., Opdam, M., et al.[2022]

A randomized controlled trial involving 246 younger women with breast cancer showed that the Comprehensive Health Enhancement Support System (CHESS) significantly improved patients' ability to seek information and participate in their care, particularly at the two-month follow-up.

The CHESS system provided greater benefits in social support and information competence at the five-month follow-up, especially for underserved populations, indicating its potential to enhance quality of life for those facing additional barriers in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of computer support on younger women with breast cancer. Gustafson, DH., Hawkins, R., Pingree, S., et al.[2022]

Adjuvant! Online (AOL) accurately predicted 10-year overall survival (OS) for young breast cancer patients (ages ≤40) with a minimal absolute difference of 0.7%, but it overestimated disease-free survival (DFS) by 7.7%.

The Nottingham Prognostic Index (NPI) significantly underestimated 10-year OS in both young (8.5%) and older (4.0%) breast cancer patients, indicating that while AOL is reliable for OS prediction in younger patients, NPI's performance is not optimal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prognostic performance of Adjuvant! Online and Nottingham Prognostic Index in young breast cancer patients. Lambertini, M., Pinto, AC., Ameye, L., et al.[2022]

A study involving 284 young breast cancer survivors found that social support, parenting concerns, and fertility concerns significantly influence their quality of life (QoL) and satisfaction with life (SwL).

Adaptive reactions positively impacted SwL, while distressing reactions negatively affected both SwL and QoL, highlighting the importance of psychological adjustment in survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Matters Most? Predictors of Quality of Life and Life Satisfaction Among Young Breast Cancer Survivors. Martens, K., Ulrich, GR., Ranby, KW., et al.[2021]

Young breast cancer patients (≤35 years) have distinct tumor characteristics, including lower hormone receptor positivity and higher HER2 positivity, which may contribute to their lower disease-free survival rates compared to older patients.

Despite undergoing more aggressive treatments like neoadjuvant therapy and mastectomy, young patients showed a significant difference in 5-year disease-free survival (81.7% vs. 91.3% for older patients), although their overall survival rates were similar (91.4% vs. 91.1%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor characteristics, therapy, and prognosis in young breast cancer patients ≤ 35 years. Eckardt, NK., Ignatov, A., Meinecke, AM., et al.[2023]

Young women with breast cancer (YWBC) face unique challenges in resource-limited settings, including inadequate care for survivorship needs and specific biological considerations, highlighting the need for targeted support.

Improving patient education is a cost-effective strategy to enhance care for YWBC, addressing issues like treatment adherence, fertility counseling, and psychosocial health, which are often neglected in these settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Young Women with Breast Cancer in Resource-Limited Settings: What We Know and What We Need to Do Better. Martinez-Cannon, BA., Barragan-Carrillo, R., Villarreal-Garza, C.[2021]

Young women with breast cancer (ages 18-40) reported both benefits and drawbacks of online support, highlighting the need for credible information and emotional connection, but also expressing concerns about distressing content.

The study identified nine key features for an ideal online support hub that could provide comprehensive informational, practical, and emotional resources, addressing the current gaps in online support for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Young Women with Breast Cancer Get Versus What They Want in Online Information and Social Media Supports. Corter, AL., Speller, B., Sequeira, S., et al.[2020]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Cancer-Specific Survival Outcome in Early-Stage Young Breast Cancer: Evidence From the SEER Database Analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Clinicopathologic and prognostic features of breast cancer in young women: a series from North of Morocco. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Long-term prognosis of young breast cancer patients (≤40 years) who did not receive adjuvant systemic treatment: protocol for the PARADIGM initiative cohort study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of computer support on younger women with breast cancer. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The prognostic performance of Adjuvant! Online and Nottingham Prognostic Index in young breast cancer patients. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

What Matters Most? Predictors of Quality of Life and Life Satisfaction Among Young Breast Cancer Survivors. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Tumor characteristics, therapy, and prognosis in young breast cancer patients ≤ 35 years. [2023]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Young Women with Breast Cancer in Resource-Limited Settings: What We Know and What We Need to Do Better. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

What Young Women with Breast Cancer Get Versus What They Want in Online Information and Social Media Supports. [2020]