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
概览
- 阶段
- 不适用
- 干预措施
- Survey Administration
- 疾病 / 适应症
- 未指定
- 发起方
- Ohio State University Comprehensive Cancer Center
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Efficacy of the Young, Empowered & Strong (YES) intervention in improving quality of life (QOL)
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
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.
详细描述
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.
研究者
Michelle Naughton
Principal Investigator
Ohio State University Comprehensive Cancer Center
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Survey Administration
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.
干预措施: Internet-Based Intervention
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.
干预措施: Survey Administration
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.
干预措施: Best Practice
结局指标
主要结局
Efficacy of the Young, Empowered & Strong (YES) intervention in improving quality of life (QOL)
时间窗: 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).
次要结局
- Quality of Life (QOL)(Up to 9 months)
- 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.(Up to 6 months)
- Sustainability of the effects of YES on AYA concerns and symptoms(Up to 9 months post-baseline, after the completion of the 6-month active intervention period)