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

• ClinicalTrials.gov Identifier: NCT04906200
• Recruitment Status: Recruiting
• First Posted: May 28, 2021
• Last Update Posted: October 31, 2022
• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Michelle Naughton, Ohio State University Comprehensive Cancer Center

Tracking Information

• First Submitted Date: May 13, 2021
• First Posted Date: May 28, 2021
• Last Update Posted Date: October 31, 2022
• Actual Study Start Date: June 28, 2021
• Estimated Primary Completion Date: August 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 25, 2021)

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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 25, 2021)

• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: May 25, 2021)

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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Web-Based Symptom Monitoring and Self-Management Portal (YES) for Adolescent and Young Adult Breast Cancer Survivors
• Official 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
• Brief Summary: This clinical trial compares a web-based patient-reported symptom monitoring and self management portal, Young, Empowered & Strong (YES), to standard therapy in managing symptoms in adolescent and young adults breast cancer survivors. YES is a web-based portal (website) to help monitor issues or symptoms women with breast cancer may experience. YES portal may improve the quality of life of young breast cancer survivors. YES portal may help manage symptoms and provide useful information/resources.

Detailed Description

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 to 2 groups.

GROUP A: Patients receive access to 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 YES portal for 3 months.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• 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
• 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

Intervention

• Other: Best Practice
  Receive usual care
  Other Names:

  • standard of care
  • standard therapy
• Other: Internet-Based Intervention
  Receive access to YES portal
• Other: Survey Administration
  Complete survey

Study Arms

• Experimental: Group A (YES portal)
  Patients receive access to YES portal for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months.
  Interventions:

  • Other: Internet-Based Intervention
  • Other: Survey Administration
• Active Comparator: Group B (usual care)
  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.
  Interventions:

  • Other: Best Practice
  • Other: Survey Administration

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 25, 2021): 360
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 31, 2025
• Estimated Primary Completion Date: August 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 15 Years to 39 Years (Child, Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: The Ohio State University Comprehensive Cancer Center; 800-293-5066; OSUCCCClinicaltrials@osumc.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04906200
• Other Study ID Numbers: OSU-21035; NCI-2021-03962 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); U01CA246648 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Michelle Naughton, Ohio State University Comprehensive Cancer Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Ohio State University Comprehensive Cancer Center
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Michelle Naughton, PhD; Ohio State University Comprehensive Cancer Center

• PRS Account: Ohio State University Comprehensive Cancer Center
• Verification Date: October 2022