Internet-Based Intervention for Young Breast Cancer Survivors

(YES Trial)

Not currently recruiting at 3 trial locations

Overseen By The Ohio State University Comprehensive Cancer Center

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Age, Stage IV, Male, others

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

Compensation: Varies

Number of Visits: 3

Duration: 9 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based tool called the Young, Empowered & Strong (YES) portal, designed to help young breast cancer survivors manage symptoms and improve quality of life. Researchers aim to determine if the YES portal is more effective than the usual care these patients receive. Women diagnosed with stage 0-III breast cancer within the last three years, who show no signs of recurrence, may be suitable for this trial. Participants will either use the YES portal or continue with their standard care while completing surveys about their experiences over nine months. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance support for breast cancer survivors.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a web-based portal to manage symptoms, so it's likely you can continue your current treatments, but you should confirm with the study team.

What prior data suggests that the YES portal is safe for young breast cancer survivors?

Research shows that the Young, Empowered & Strong (YES) portal is a digital tool designed to help young women who have survived breast cancer manage their symptoms. Studies have found that it helps users track both physical and emotional symptoms. As an online platform, YES is neither a medication nor a medical device, so it lacks the usual side effects associated with drugs.

Because YES is a web portal, safety concerns are minimal and mostly related to user experience rather than physical health risks. No reports of serious problems have emerged from using this type of digital tool. The main goal is to provide helpful information and support, which can improve the quality of life for young breast cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the YES intervention because it offers a unique online support system specifically designed for young breast cancer survivors. Unlike traditional treatments that focus on medical care, YES provides emotional and psychological support through an accessible internet portal. This intervention aims to empower young survivors by addressing their distinct needs and challenges, potentially enhancing their overall quality of life during recovery.

What evidence suggests that the YES portal is effective for managing symptoms in young breast cancer survivors?

Research has shown that the Young, Empowered & Strong (YES) Portal could benefit young breast cancer survivors. In this trial, participants in Group A will access the YES Portal for 9 months. Studies indicate that this online tool allows users to track symptoms and progress, helping manage the physical and emotional challenges of breast cancer. The YES Portal also offers personalized education and support, which may enhance quality of life. Early findings suggest a positive impact, though further research could strengthen this claim. ^{1 2 4 6 7}

Who Is on the Research Team?

Michelle Naughton, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Ability to access medical records from treating hospital

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

I am willing to share my contact details and receive messages from the study team.

Exclusion Criteria

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

I am either younger than 15 or older than 42.

I am a young woman with breast cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive access to the YES portal or usual care for 9 months, with surveys completed at baseline and 3, 6, and 9 months

9 months

Surveys at baseline, 3, 6, and 9 months

Follow-up

Participants are monitored for sustainability of effects on quality of life and symptoms after the 6-month intervention period

3 months

Open-label extension (optional)

Participants in the usual care group may receive access to the YES portal for an additional 3 months

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Young, Empowered & Strong (YES)

Trial Overview 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.

How Is the Trial Designed?

Group I: Group A (YES portal) Experimental Treatment 2 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 Control 2 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.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 200 young women (35 years or younger) with node-positive breast cancer, the number of positive lymph nodes was identified as a key prognostic factor for recurrence, indicating that those with more involved nodes are at higher risk for disease-related events.

After a median follow-up of 52.4 months, the study found that 84 patients experienced disease-related events, with the majority being distant metastases, suggesting that tailored follow-up strategies based on lymph node involvement could improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic factors of young women (≤ 35 years) with node positive breast cancer: possible influence on post-therapeutic follow-up. Filleron, T., Md, FD., Kramar, A., et al.[2013]

Teenage and young adult cancer survivors express a strong need for online self-management support, which could supplement traditional clinical interactions, as indicated by a mixed methods study involving 24 survey participants and 24 interviews across various stakeholders.

While there is enthusiasm for web-based resources, challenges such as governance issues and risks to young users must be addressed to effectively implement these systems for long-term support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based self-management for young cancer survivors: consideration of user requirements and barriers to implementation. Moody, L., Turner, A., Osmond, J., et al.[2022]

The Georgia Cancer Registry successfully contacted 60% of eligible female young adult cancer survivors, with 78% agreeing to study contact, highlighting the registry's effectiveness in reaching this population.

Participation rates varied by cancer type, with breast cancer survivors showing a higher interview rate (32%) compared to cervical cancer survivors (17%), indicating that cancer type may influence recruitment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Young Adult Female Cancer Survivors Recruited from a Population-Based Cancer Registry to Eligible Survivors. Howards, PP., Mink, PJ., Kim, KH., et al.[2022]

A survey of 163 young breast cancer survivors revealed that 94% found the survivorship care plan (SCP) helpful for managing their treatment and follow-up, indicating its efficacy in supporting their care.

75% of participants were satisfied with the timing of receiving the SCP kit, suggesting that timely access to resources is crucial for enhancing the quality of life for young breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"When I Needed It": Evaluation of the Use and Timing of Sharsheret's Thriving Again Program for Young Breast Cancer Survivors. Rohan, EA., Townsend, JS., Fleischmann, A., et al.[2019]

A study involving 31 young adult cancer survivors identified key resource needs during their transition from treatment to survivorship, including concerns about fear of recurrence, sleep and fatigue, anxiety, nutrition, physical activity, and finances.

Participants emphasized the importance of tailored support, connection with other survivors, and clear guidance on what to expect during treatment and survivorship, highlighting the need for equitable and customizable resources in young adult oncology care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active Treatment to Survivorship Care: A Mixed-Methods Study Exploring Resource Needs and Preferences of Young Adult Cancer Survivors in Transition. Camp, L., Coffman, E., Chinthapatla, J., et al.[2023]

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]

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]

A study involving 21 young cancer patients (ages 13-24) revealed that their use of the Internet for information and support is influenced by their emotional state and where they are in their cancer journey, highlighting the need for tailored online resources.

Participants utilized various online platforms, but their needs were often unmet, indicating a significant opportunity to develop more effective, youth-centered digital resources in collaboration with young people themselves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online information and support needs of young people with cancer: a participatory action research study. Lea, S., Martins, A., Morgan, S., et al.[2022]

Young adult cancer survivors (YAS) show high satisfaction with Internet-based survivorship care plans (SCPs), with 93% reporting content satisfaction and 71% sharing their plans with healthcare providers.

Despite experiencing significant late effects like fatigue and neurocognitive concerns, YAS reported fewer late effects overall compared to older adult survivors, suggesting that SCPs may effectively address their specific needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship Care Planning for Young Adults After Cancer Treatment: Understanding Care Patterns and Patient-Reported Outcomes. Szalda, D., Schapira, MM., Jacobs, LA., et al.[2019]

A new self-help Web-based intervention called Fex-Can is being developed to help young cancer patients address sexual problems and fertility concerns, with input from former patients and their significant others to ensure the content is relevant and engaging.

The development process involved extensive collaboration with patient research partners, leading to improvements in the intervention's content, design, and support services, which will be tested in a feasibility study and a randomized controlled trial to evaluate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Self-Help Web-Based Intervention Targeting Young Cancer Patients With Sexual Problems and Fertility Distress in Collaboration With Patient Research Partners. Winterling, J., Wiklander, M., Obol, CM., et al.[2022]

The Young & Strong study aims to improve the attention given to fertility concerns among young women diagnosed with breast cancer, as these concerns are linked to other important issues such as psychosocial distress and body image, which are often overlooked in treatment plans.

This study involves a cluster randomized design across 14 academic institutions and 40 community sites, focusing on enhancing communication between oncologists and young patients to ultimately reduce psychosocial distress and improve overall care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for Young & Strong: a cluster randomized design to increase attention to unique issues faced by young women with newly diagnosed breast cancer. Greaney, ML., Sprunck-Harrild, K., Ruddy, KJ., et al.[2019]

A 6-month goal-oriented rehabilitation program significantly improved participation and satisfaction among 16 young adult cancer survivors, as measured by the Canadian Occupational Performance Measure.

Key components of the program included physical activity, psychoeducation, and peer support, highlighting the importance of ongoing follow-up and empowerment in the rehabilitation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participating in life again: a mixed-method study on a goal-orientated rehabilitation program for young adult cancer survivors. Hauken, MA., Holsen, I., Fismen, E., et al.[2022]

Citations

1. youngandstrong.dana-farber.org youngandstrong.dana-farber.org/research-studies.html

Research Studies - Dana-Farber Young and Strong The YES Portal is an online, web-based platform, where young women can self-monitor their physical and psychosocial symptoms and track their progress.

2. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-025-21288-4

Young, Empowered & strong (YES): a study protocol paper for ... The Young, Empowered and Strong (YES) trial tests the efficacy of a 9-month, multicomponent digital health intervention that includes monthly assessments of ...

3. ascopubs.org ascopubs.org/doi/abs/10.1200/CCI.21.00067

Young, Empowered and Strong: A Web-Based Education ... Young, Empowered and Strong (YES) is an interactive web-based intervention designed to engage young women with personalized education and symptom self- ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04379414?cond=breast%20cancer&term=young%20women&aggFilters=status:rec&rank=10

YES Study - 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 ...

5. greenlighthealth.com greenlighthealth.com/portfolio/yes-young-empowered-strong/

YES (Young, Empowered & Strong) Brief Summary: This research study is being done to monitor common symptoms and behavior, and to provide supportive care information and peer support, ...

6. cancer.columbia.edu cancer.columbia.edu/cancer-types-care/clinical-trials/find-clinical-trial/young-empowered-strong-yes-web-based-patient-reported-symptom-monitoring-andself-management-portal-adolescent-and-young-adult-breast-cancer-survivors

Young, Empowered Strong (YES): A web-based patient ... The Young, Empowered & Strong (YES) study is opened to women who were diagnosed with breast cancer between the ages of 15 and 39 years.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39799291/

Young, Empowered & strong (YES): a study protocol paper for ... The Young, Empowered and Strong (YES) trial tests the efficacy of a 9-month, multicomponent digital health intervention that includes monthly assessments of ...