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Active, Not Recruiting

NCT Number: NCT04906200

Web-Based Symptom Monitoring and Self-Management Portal (YES) for Adolescent and Young Adult Breast Cancer Survivors

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prognostic Stage 0 Breast Cancer AJCC v8 Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage IA Breast Cancer AJCC v8 Prognostic Stage IB Breast Cancer AJCC v8 Prognostic Stage II Breast Cancer AJCC v8 Prognostic Stage IIA Breast Cancer AJCC v8 Prognostic Stage IIB Breast Cancer AJCC v8 Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8 Skin Diseases Skin and Connective Tissue Diseases

Age range

15 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

PRIMARY OBJECTIVES:

I. To determine the efficacy of the YES intervention compared to usual care in improving quality of life (QOL), as measured by the Quality of Life in Adult Cancer Survivors (QLACS) at 6-months (primary outcome).

II. To determine the efficacy of the YES intervention compared to usual care in reducing specific adolescent and young adult (AYA) breast cancer (BC) concerns and symptoms at 6-months.

III. To determine the sustainability of the effects of YES on AYA concerns, symptoms, and QOL at 9 months, after the completion of the 6-month active intervention period.

EXPLORATORY OBJECTIVE:

I. To explore potential moderators and mediators of intervention efficacy, and to explore the potential effects of the intervention on inflammatory and other biomarkers including genetic profiles.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP A: Patients receive access to the YES portal for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months.

GROUP B: 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 the YES portal for 3 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • Age 15-39 years at diagnosis of a stage 0-III breast cancer
  • Within 3 years of breast cancer diagnosis
  • No known evidence of breast cancer recurrence (local or distant) or second primary breast cancer
  • No prior history of new other malignancy since their breast cancer diagnosis (other than non-melanoma skin cancer)
  • Able to speak, understand and read English
  • Cognitively able to complete the study requirements
  • Ability to access medical records from treating hospital
  • Willing to provide cell phone number and/or email address, and willing to receive email and/or text messages from the study team either with their own smartphone or one provided by the study team if they do not have their own to use
  • Pregnant survivors are also eligible for this protocol, given that fertility and pregnancy are important AYA issues

Exclusion criteria

  • Individuals under age 15 or over age 42
  • Stage IV or metastatic breast cancer
  • Males with breast cancer are not being recruited to this protocol. In the AYA age group, only a miniscule proportion of breast cancers occur in males. For this reason, the YES portal intervention materials have been targeted for young women

Treatment and study plan

Best Practice

Other

Receive usual care

Other names: standard of care, standard therapy

Internet-Based Intervention

Other

Receive access to YES portal

Survey Administration

Other

Complete survey

Primary outcomes

  1. Efficacy of the Young, Empowered & Strong (YES) intervention in improving quality of life (QOL)

    Time frame: Up to 6 months

    Will determine the efficacy of the YES intervention compared to usual care in improving QOL, as measured by the Quality of Life in Adult Cancer Survivors Scale at 6-months (primary outcome). The QLACS contains 47 items scored on a 1 (never) to 7 (always) scale. The 47 items are grouped into 12 domains (7 generic and 5 cancer-specific). A QLACS generic summary score is calculated by adding the 7 constituent domain scores, so that a lower score (range: 31-143) corresponds to higher QOL. A QLACS cancer-specific summary score (range: 16-99) is calculated by adding the constituent domain scores of all but the "benefits" domain. The benefits domain is scored separately (range: 4-28).

Secondary outcomes

  1. Efficacy of the YES intervention in reducing specific adolescent and young adult (AYA) breast confident (BC) concerns and symptoms at 6-months compared to baseline.

    Time frame: Up to 6 months

    AYA concerns and symptoms will be measured by items from the AYA HOPE Study questionnaire that asks patients to indicate their need for information regarding a range of AYA survivorship-focused issues, including fertility, diet and nutrition, physical activity, weight management, survivorship care, recurrence concerns, and financial support for medical care. Symptoms assessed include sexual problems, anxiety, fatigue, stress, depression, sleep problems, hot flashes, and musculoskeletal complaints. Changes in concerns and symptoms will be examined using the frequencies of the report of needs and symptoms between baseline and 6 months. Lower frequencies of concerns and symptoms, as compared to their baseline levels, both indicate better outcomes.

  2. Sustainability of the effects of YES on AYA concerns and symptoms

    Time frame: Up to 9 months post-baseline, after the completion of the 6-month active intervention period

    Frequencies of AYA concerns for information and frequencies of symptoms at 9 months will be compared to the same frequencies at 6 months (the end of the intervention period). Better outcomes will be the same or lower frequencies of AYA concerns and symptoms at 9 months, as compared to the 6-month assessment point.

  3. Quality of Life (QOL)

    Time frame: Up to 9 months

    Determine the Sustainability of the effects of YES on participants' quality of life, as measured by the generic (range: 31-143) and cancer-specific (range: 16-99) summary scores of the Quality of Life in Adult Cancer Survivors scale, from month 6 to month 9. Sustainability will be determined by both subscale scores maintaining the same or lower scores at 9 months as compared to their respective scores at month 6.

Other outcomes

  1. Potential effects of the intervention on inflammatory and other biomarkers and genetic profiles

    Time frame: Baseline and 6 months

    We will measure pro- and anti-inflammatory cytokines (IL1β, IL6, IL8, IL10, TNF- α, and CRP) from participants' blood samples. We will also evaluate pro-inflammatory cytokine genes using microarray-based genome-wide transcriptional profiling to identify genes that show differential expression in leukocytes, aiming to accurately identify activation of specific transcription control pathways, including the pro-inflammatory NF-kB and decreased GR signaling. These pathways are hypothesized to underlie increased inflammatory activity, which may be more sensitive to our intervention than circulating cytokines, with improved symptom control and improved quality of life.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • Columbia University
  • Dana-Farber Cancer Institute
  • National Cancer Institute (NCI)

Registry information

Official study title

Randomized Controlled Trial of Young, Empowered &Amp; Strong (YES), a Web-Based Patient-Reported Symptom Monitoring and Self-Management Portal for Adolescent and Young Adult Breast Cancer Survivors

Acronym: YES

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 28, 2021
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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