INSPIRE-AYA: A Multicenter Interactive Survivorship Program to Improve Healthcare Resources for Adolescent and Young Adult (AYA) Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 549
- 试验地点
- 10
- 主要终点
- Change in distress score from baseline to 3 months
研究概览
简要总结
This trial studies how well an interactive survivorship program works in improving healthcare resources in adolescent and young adult cancer survivors. By improving access to survivorship resources, health literacy, self-management skills, and support, an interactive survivorship program may help to improve adherence to adolescent and young adult healthcare guidelines and reduce cancer-related distress.
详细描述
OUTLINE: Patients who have one or more elevated distress or low cardiometabolic or cancer health care adherence are randomized to Arm I or II.
ARM I (INTERVENTION): Patients receive a personalized Survivorship Care Plan (SCP) and use the Interactive Survivorship Program to Improve Healthcare Resources (INSPIRE) mobile application. Patients may receive telehealth stepped care after 1 month.
ARM II (CONTROL): Patients receive access to a study-specific control website that has annotated links to existing resources for adolescent and young adult (AYA) survivors. After 12 months, patients receive a personalized SCP and have access to the digital INSPIRE intervention program without telehealth calls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with a first invasive malignancy of leukemia, lymphoma, melanoma, sarcoma, breast, thyroid, or colorectal cancer (stage 1-3 for solid tumors) between the ages of 15-39 years
- •Current age >= 18 when approached
- •Currently within 1 to 5 years from the time of diagnosis
- •Completed active treatment for disease >= 6 months previously
- •Received a therapeutic intervention (with curative intent if advanced stage disease) that included any of the following modalities: surgery, cytotoxic chemotherapy, biological or targeted agents, radiation therapy
- •English proficiency adequate to complete assessments
- •Access to email and smartphone mobile app and or internet
排除标准
- •Diagnosed with a subsequent invasive malignancy other than non-melanoma skin cancer
- •Received hematopoietic stem cell transplant
- •Health issues prohibiting computer use or ability to comply with study procedures
- •Residing in an institution or other living situation where health care decisions are not made by the participant (e.g., hospitalized, prisoners, living in a rehabilitation facility)
- •Does not complete baseline patient reported outcome (PRO) assessment items required to determine stratification or whether the survivor meets inclusion and exclusion criteria
研究组 & 干预措施
Arm I (INSPIRE, telehealth care)
Patients receive a personalized SCP and use the INSPIRE mobile application. Patients may receive telehealth stepped care after 1 month.
干预措施: Internet Mobile Technology (Other)
Arm I (INSPIRE, telehealth care)
Patients receive a personalized SCP and use the INSPIRE mobile application. Patients may receive telehealth stepped care after 1 month.
干预措施: Questionnaire Administration (Other)
Arm I (INSPIRE, telehealth care)
Patients receive a personalized SCP and use the INSPIRE mobile application. Patients may receive telehealth stepped care after 1 month.
干预措施: Supportive Care (Procedure)
Arm I (INSPIRE, telehealth care)
Patients receive a personalized SCP and use the INSPIRE mobile application. Patients may receive telehealth stepped care after 1 month.
干预措施: Informational Intervention (Other)
Arm II (control website)
Patients receive access to a study-specific control website that has annotated links to existing resources for AYA survivors. After 12 months, patients receive a personalized SCP and have access to the digital INSPIRE intervention program without telehealth calls.
干预措施: Internet-Based Intervention (Other)
Arm II (control website)
Patients receive access to a study-specific control website that has annotated links to existing resources for AYA survivors. After 12 months, patients receive a personalized SCP and have access to the digital INSPIRE intervention program without telehealth calls.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in distress score from baseline to 3 months
时间窗: From baseline to 3 months
Will be assessed by Cancer and Treatment Distress (CTXD). The CTXD is a 22 item Likert type scale that contains 6 subscales: uncertainty, health burden, identity, medical demands, finances, and family strain. Scores on individual items range from 0 (none) to 3 (severe) distress related to an aspect of the cancer experience. Patients will meet the primary endpoint for lack of distress if they score \< 0.9 on the CTXD.
Change in distress score from baseline to 12 months
时间窗: From baseline to 12 months
Will be assessed by Cancer and Treatment Distress (CTXD). The CTXD is a 22 item Likert type scale that contains 6 subscales: uncertainty, health burden, identity, medical demands, finances, and family strain. Scores on individual items range from 0 (none) to 3 (severe) distress related to an aspect of the cancer experience. Patients will meet the primary endpoint for lack of distress if they score \< 0.9 on the CTXD.
次要结局
- Proportion of healthcare adherence (HCA)-all(At 12 months)
- Proportion of HCA-cardiometabolic surveillance (CM)(At 12 months)
- Proportion of HCA-cancer surveillance (SM)(At 12 months)