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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-03962 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| U01CA246648 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Dana-Farber Cancer Institute | OTHER |
| Columbia University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (YES portal) | Experimental | Patients receive access to YES portal for 9 months. Patients also complete surveys at baseline and 3, 6, and 9 months. |
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| Group B (usual care) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual care |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the Young, Empowered & Strong (YES) intervention in improving quality of life (QOL) | 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). | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Potential effects of the intervention on inflammatory and other biomarkers and genetic profiles | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Naughton, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States | ||
| Columbia University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39799291 | Background | Dibble KE, Rosenberg SM, Snow C, Kirkner GJ, Tayob N, Contreras M, Roma ND, DeGraffinreid CR, Nolan TS, Hershman DL, Naughton M, Partridge AH. Young, Empowered & strong (YES): a study protocol paper for a randomized controlled trial of an mHealth symptom monitoring and self-management intervention for adolescent and young adult (AYA) breast cancer survivors. BMC Public Health. 2025 Jan 11;25(1):126. doi: 10.1186/s12889-025-21288-4. |
| Label | URL |
|---|---|
| The Jamesline | View source |
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| Internet-Based Intervention | Other | Receive access to YES portal |
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| Survey Administration | Other | Complete survey |
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| Up to 6 months |
| Sustainability of the effects of YES on AYA concerns and symptoms | 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. | Up to 9 months post-baseline, after the completion of the 6-month active intervention period |
| Quality of Life (QOL) | 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. | Up to 9 months |
| Baseline and 6 months |
| New York |
| New York |
| 10032 |
| United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| ID | Term |
|---|---|
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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