跳至主要内容
临床试验/NCT07416513
NCT07416513招募中不适用

ALTHEA: tAckLing menTal Health Cancer Patients and Their Families: Digital Solutions for bEtter cAre

European Institute of Oncology5 个研究点 分布在 5 个国家目标入组 200 人开始时间: 2025年5月14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
200
试验地点
5
主要终点
Number of unmet needs of patients, caregivers and Health Care Professionals (HCPs)

研究概览

简要总结

The target population includes cancer patients, caregivers, family members, healthcare providers and mental health specialists, who will be the primary end-users of the Althea platform. For patients, survivors, caregivers, and family members, the sample variables include age, gender, type and stage of disease, and time since the first diagnosis. The healthcare professionals that will be involved in this study are those who attend to oncological patients, with sample variables such as age, gender, professional role, and prior experience and training in oncology or psycho-oncology.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HEALTHCARE PROFESSIONALS:
  • Healthcare professionals actually working in oncology and/or psychooncology;
  • Teachers of paediatric cancer patients.
  • ADULT POPULATION:
  • Patients with a current or previous cancer diagnosis
  • Adequate language proficiency,
  • Able to provide informed consent;
  • PAEDIATRIC POPULATION:
  • Older than 12 years of age;
  • Patients with a current or previous cancer diagnosis;
  • Adequate language proficiency;
  • Legal guardians of paediatric cancer patients able to provide informed consent.
  • CAREGIVERS:
  • Caregivers and/or family members of cancer patients who lived or assist the loved ones with a current or previous cancer diagnosis in the cancer journey;
  • Adequate language proficiency;
  • Able to provide informed consent;
  • Caregivers and/or family members of paediatric cancer patients under 12 years of age.

排除标准

  • Healthcare professionals with limited oncology patient contact;
  • Insufficient knowledge of the local language;
  • Severe cognitive impairment, and/or mental disorders that prohibited their participation in the study or inadequate verbal skills that may render them incapable of informed consent (as evaluated by the clinician);
  • Inability to understand the study materials (as evaluated by the clinician);
  • Physical or psychological impairment that prohibits their participation in focus groups (as evaluated by the clinician).

研究组 & 干预措施

Patients, survivors, caregivers, family members and healthcare professionals

Experimental

Focus group discussions (FGD) and completion of survey

干预措施: Patients, survivors, caregivers, family members and healthcare professionals (Behavioral)

结局指标

主要结局

Number of unmet needs of patients, caregivers and Health Care Professionals (HCPs)

时间窗: 15 months

Number of unmet needs reported by patients, caregivers and Health Care Professionals (HCPs)

次要结局

未报告次要终点

研究者

发起方
European Institute of Oncology
申办方类型
Other
责任方
Sponsor

研究点 (5)

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