Internet-Based Intervention for Young Breast Cancer Survivors

(YES Trial)

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

400 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial compares a web-based patient-reported symptom monitoring and self management portal, the Young, Empowered \& Strong (YES), to standard therapy in managing symptoms in adolescent and young adult breast cancer survivors. YES is a web-based portal (website) to help monitor issues or symptoms women with breast cancer may experience. The YES portal may improve the quality of life of young breast cancer survivors. The YES portal may help manage symptoms and provide useful information/resources.

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 data supports the idea that Internet-Based Intervention for Young Breast Cancer Survivors is an effective treatment?

The available research shows that the Internet-Based Intervention for Young Breast Cancer Survivors, like the Sharsheret's Thriving Again program, is effective because most participants found it helpful. Specifically, 94% of women said it helped with cancer treatment, 85% with follow-up, and 91% with discussions with their doctors. Additionally, 75% of women were satisfied with the timing of receiving the support kit. This suggests that the program is beneficial in providing timely and useful support to young breast cancer survivors. ^{1 2 3 4 5}

What data supports the effectiveness of the Internet-Based Intervention for Young Breast Cancer Survivors treatment?

The evaluation of Sharsheret's Thriving Again program, which is similar to the YES Portal, showed that most young breast cancer survivors found the survivorship care plan helpful for managing treatment and follow-up, with 94% finding it facilitated cancer treatment and 85% finding it useful for follow-up. This suggests that internet-based interventions can be beneficial for young breast cancer survivors. ^{1 2 3 4 5}

What safety data exists for the Internet-Based Intervention for Young Breast Cancer Survivors?

The provided research does not directly address safety data for the Internet-Based Intervention for Young Breast Cancer Survivors, including the YES Portal. The studies focus on survivorship care planning, fertility issues, program evaluations, and rehabilitation for young breast cancer survivors, but do not specifically mention safety data for the YES intervention or similar programs. ^{1 2 6 7 8}

Is the Internet-Based Intervention a promising treatment for young breast cancer survivors?

Yes, the Internet-Based Intervention is promising because it offers young breast cancer survivors valuable support and resources. It helps them manage their health, connect with others, and improve their quality of life through online tools and information. ^{2 9 10 11 12}

How does the Internet-Based Intervention for Young Breast Cancer Survivors differ from other treatments?

This treatment is unique because it is an online self-help program specifically designed to address the sexual and fertility concerns of young breast cancer survivors, leveraging the familiarity of young people with internet technologies to provide psycho-educational support remotely. ^{2 9 10 11 12}

Research Team

Michelle Naughton, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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 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]

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]

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]

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 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]

References

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

Survivorship Care Planning for Young Adults After Cancer Treatment: Understanding Care Patterns and Patient-Reported Outcomes. [2019]

2. England 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. [2019]

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

Active Treatment to Survivorship Care: A Mixed-Methods Study Exploring Resource Needs and Preferences of Young Adult Cancer Survivors in Transition. [2023]

5. France pubmed.ncbi.nlm.nih.gov

Prognostic factors of young women (≤ 35 years) with node positive breast cancer: possible influence on post-therapeutic follow-up. [2013]

6. England 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. [2019]

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

Comparison of Young Adult Female Cancer Survivors Recruited from a Population-Based Cancer Registry to Eligible Survivors. [2022]

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

Participating in life again: a mixed-method study on a goal-orientated rehabilitation program for young adult cancer survivors. [2022]

9. Canada 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. [2022]

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

Web-based self-management for young cancer survivors: consideration of user requirements and barriers to implementation. [2022]

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

Online information and support needs of young people with cancer: a participatory action research study. [2022]

12. 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]