Tailored Health Literacy Follow-up in Cancer

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Tailored Health Literacy follow-up in cancer
  1. Participants are invited to a consultation with the project nurse where the project nurse will use baseline data to identify the patient's HL needs, QOL, symptom burden and issues related to self-management of their cancer and treatment. These data will be used together with an interview questionnaire specifically developed to communicate HL needs (i.e. CHAT), which form the basis for the individualized HL support. 2. Actions: Based on results of the consultation, the project nurse and the pa

Первичные конечные точки

• General Health literacy measured with the Health Literacy Questionnaire (HLQ) [Срок оценки: 6 months, 9 months]

Вторичные конечные точки (8)

• Electronic Health Literacy measured with the electronic Health Literacy Questionnaire (eHLQ) [Срок оценки: 6 months, 9 months]
• General symptoms measured with the Edmonton Symptom Assessment System (ESAS) [Срок оценки: 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) [Срок оценки: 6 months, 9 months]
• Self-management measured with the Health Education Impact Questionnaire (HeiQ) [Срок оценки: 6 months, 9 months]
• Self-Efficacy measured with the General Self-efficacy Scale (GSE) [Срок оценки: 6 months, 9 months]
• Disease specific Quality of Life measured with the The functional Assessment of Cancer Therapy-General (FACT-G) [Срок оценки: 6 months, 9 months]
• Generic health-related quality of life/quality adjusted life years measured by the EQ-5D [Срок оценки: 6 months, 9 months]
• Health care costs measured through collecting data from patient medical records, patient self-report, and data registers [Срок оценки: 6 months, 9 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Норвегия · 1 центр

• Lovisenberg Diakonale Hospital — Oslo

Идентификаторы

NCT: NCT05627180 · 341

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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