AlloCare - Support and Management of Late Effects After Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Quality of life - summary score measured by European Organisation for Research and Treatment of Cancer QOL questionnaire (EORTC-QOL-C30)
研究概览
简要总结
A developed multimodal intervention targeting late effects in survivors of allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be evaluated in a two-arm randomized controlled trial with an internal pilot phase.
详细描述
The study aims to investigate the effect of a stepped care intervention in allo-HSCT survivors on health-related quality of life and late effects.
Method:
This study is designed as a one-site, two-arm prospective randomized controlled trial proceeding an internal pilot phase.
Population/recruitment:
Recruitment, inclusion, and exclusion criteria as described in the eligibility section. Included patients will be randomized and allocated 1:1 to an intervention group or a control group.
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
- •Adult patients (age> 18 years) treated with myeloablative or non-myeloablative HSCT in outpatient follow-up without recurrent disease are eligible for inclusion.
排除标准
- •Patients with recurrence or subsequent malignancy requiring cancer treatment or lack of access to email and the Internet will be excluded.
结局指标
主要结局
Quality of life - summary score measured by European Organisation for Research and Treatment of Cancer QOL questionnaire (EORTC-QOL-C30)
时间窗: 15 months (baseline 3, post intervention 12 and follow-up 18 month after treatment with allogeneic stem cell transplantation)
Between-group changes in Quality of life - from baseline 3 months post treatment with allogenenic stem cell transplantation to postintervention 12 months post treatment with allogeneic stem cell transplantation. EORTC Quality of Life core questionnaire (QLQ-C30). The EORTC QoL Core Questionnaire EORTC QLQ-C30 is a 30-item instrument designed to measure quality of life in all cancer patients. The questionnaire consists of five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and some single items assessing additional symptoms commonly reported by cancer patients
次要结局
- Survivorship specific quality of life(15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation))
- Health literacy(15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation))
- Referrals to municipality rehabilitation(15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation))
- Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale(15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation))
研究者
Mette Schaufuss Engedal
Clinical nurse specialist, Ph.d student
Rigshospitalet, Denmark