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临床试验/NCT07579065
NCT07579065招募中不适用

Survivorship Care in Patients With Hematologic Cancer Undergoing HSCT: A Feasibility Study on Quality of Life, Unmet Needs, and Caregivers Burden

Azienda USL Reggio Emilia - IRCCS1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1

研究概览

简要总结

This is a feasibility study to implement a Survivorship Care (SC) Plan for patients with hematologic cancer undergoing hematopoietic stem cell transplantation (HSCT). The study evaluates if the intervention is feasible within the Italian national health system, focusing on retention rates, quality of life, unmet needs and caregiver burden

详细描述

Haematopoietic stem cell transplantation (HSCT), whether autologous or allogeneic, is a cornerstone of modern haematological oncology, with the volume of procedures steadily increasing both globally and nationally. The rise in survival rates beyond 12 months has made the management of long-term survivorship an emerging clinical and epidemiological priority.Despite its curative efficacy, HSCT and associated cytotoxic treatments lead to late and chronic complications that cause significant functional, social and psychological impairment. Factors such as recurrent infections, prolonged isolation and reduced mobility have a negative impact on quality of life, functional capacity and fatigue levels. At the same time, informal carers (family members or friends) bear a significant caregiving and emotional burden that threatens their overall well-being.An integrated assessment of the needs of both the patient and the carer as the core unit of care is essential to provide adequate support. Although Survivorship Care (SC) is recommended for the systematic management of late effects, its implementation in structured and sustainable models within the National Health Service remains complex.This prospective, single-center, single-arm study follows patients from hospital discharge to 6 months post-transplant. The intervention consists of a personalized SC Plan including treatment summaries, follow-up recommendations, and referrals to supportive services. Data on feasibility, quality of life (EORTC QLQ-C30), unmet needs (SCNS-SF34), and caregiver burden (CRA) will be collected at T0 (baseline), T1 (100 days), and T2 (6 months).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Patients with hematologic cancer candidates for HSCT (autologous or allogeneic) and their informal caregivers
  • Able to provide informed consent
  • Able to communicate in Italian

排除标准

  • Patients or caregivers with comorbidities hindering participation (e.g., significant cognitive limitations)

研究组 & 干预措施

Survivorship Care Plan

Other

Patients undergoing haematopoietic stem cell transplantation (HSCT), either autologous or allogeneic.

干预措施: Survivorship Care (SC) Plan (Other)

研究者

发起方
Azienda USL Reggio Emilia - IRCCS
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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