跳至主要内容
临床试验/NCT05627180
NCT05627180招募中不适用

Tailored Health Literacy Follow-up in Cancer - the Tail HealthLit Cancer Trial

Lovisenberg Diakonale Hospital2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
2
主要终点
General Health literacy measured with the Health Literacy Questionnaire (HLQ)

研究概览

简要总结

Health literacy refers to personal and relational factors affecting a persons ability to aquire, understand and use health information and health services. In a need assessment study, it was found that there is a need to focus on health literacy factors in the follow-up of people with cancer in the health care services.

Thus, this project evaluate the effect of a health literacy intervention in cancer. The intervention provides patients with nurse-led tailored follow-up by phone/digital/personal meetings that addresses their individual HL needs, particularly those needs that impact their quality of life, symptom burden, self-management, and health economic costs. Our main goal is to improve the patients' health literacy, with secondary goals of improving their quality of life, symptom burden, and self-management, and reducing their health care costs.

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
Single (Investigator)

盲法说明

The main researcher and PhD candidate will be blinded to the randomizing procedure. However, in this project, it is not feasible to blind the participants, HCPs or PhD candidate to the participants' group. The participants will be randomized right after the first assessment.

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

  • Diagnosed with cancer
  • Above 18 years old
  • Receiving treatment at the main intervention hospital

排除标准

  • Not diagnosed with cancer
  • Not above 18 years old
  • Not in treatment at the intervention hospital

结局指标

主要结局

General Health literacy measured with the Health Literacy Questionnaire (HLQ)

时间窗: 6 months, 9 months

Change of Health Literacy questionnaire

次要结局

  • Self-Efficacy measured with the General Self-efficacy Scale (GSE)(6 months, 9 months)
  • Disease specific Quality of Life measured with the The functional Assessment of Cancer Therapy-General (FACT-G)(6 months, 9 months)
  • Electronic Health Literacy measured with the electronic Health Literacy Questionnaire (eHLQ)(6 months, 9 months)
  • Oral symptoms measured with four items selected from the European Organization for REsearch and Treatment of Cancer-oral health 15 (EORTC-OH 15)(6 months, 9 months)
  • Health care costs measured through collecting data from patient medical records, patient self-report, and data registers(6 months, 9 months)
  • General symptoms measured with the Edmonton Symptom Assessment System (ESAS)(6 months, 9 months)
  • Self-management measured with the Health Education Impact Questionnaire (HeiQ)(6 months, 9 months)
  • Generic health-related quality of life/quality adjusted life years measured by the EQ-5D(6 months, 9 months)

研究者

发起方
Lovisenberg Diakonale Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christine Råheim Borge

Researcher

Lovisenberg Diakonale Hospital

研究点 (2)

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