Randomized Controlled Trial of a Psychosocial Mobile Application (App) to Promote Coping for Caregivers of Patients Receiving Hematopoietic Cell Transplantation (HCT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire
研究概览
简要总结
The goal of this research study is to determine whether a self-administered, psychosocial mobile application (CARE app) is effective at improving the quality of life and experience of caregivers of patients receiving hematopoietic stem cell transplantation (HCT).
详细描述
This is a randomized clinical trial to determine whether a psychosocial mobile application (CARE app) is effective at improving the quality of life and experience of caregivers of patients receiving hematopoietic stem cell transplantation (HCT). The CARE app was developed with the goal of addressing the needs of caregivers of HCT recipients.
Participants will be randomized into one of two study groups: CARE app plus Usual Care versus Usual Care.
Participation in this study is expected to last up to 100 days after HCT.
It is expected that about 120 people will take part in this research study.
The Leukemia and Lymphoma Society is supporting this research by providing funding.
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
- None
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
- •Caregiver Inclusion Criteria:
- •Adult caregivers (>18 years) who is a relative or friend who live with the patient or is a designated caregiver as indicated during the transplant process.
- •Caregiver of a patient receiving allogeneic or autologous HCT for the treatment of cancer
- •Ability to comprehend and speak English as the CARE app is only available in English
排除标准
- •Caregivers of patients undergoing HCT for benign hematologic conditions
- •Caregivers with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures
研究组 & 干预措施
CARE App
Participants randomized to the CARE app + usual care will complete the following:
- Questionnaires at baseline, Day 10, Day 60, and Day 100 post-HCT
- use the CARE app from enrollment up to 60 days post-HCT: the CARE app includes 5 contains 5 modules and a 6th optional module
- receive usual care as per HCT practice which entails meeting with a transplant social worker prior to HCT and as needed for extra visits
干预措施: CARE Application (Behavioral)
Usual Care
Participants randomized to usual care will complete the following:
- Questionnaires at baseline, Day 10, Day 60, and Day 100.
- receive usual care as per HCT practice, which entails meeting with a transplant social worker prior to HCT and as needed for extra visits.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire
时间窗: up to 60 days post-HCT
Compare caregiver QOL as measured by the CARGOQOL between the two study groups. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL
次要结局
- Depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)(Up to 100 days post HCT)
- Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire(up to 100 days post HCT)
- Anxiety symptoms as measured by the Hospital Anxiety and Depression scale (HADS-Anxiety)(Up to 100 days post HCT)
- Caregiving burden as measured by the Caregiver Reaction Assessment (CRA)(Up to 100 days post HCT)
- Post-traumatic stress symptoms (PTSD) as measured by the PTSD Checklist(Up to 100 days post HCT)
研究者
El-Jawahri, Areej,M.D.
Principal Investigator
Massachusetts General Hospital