Tailored Health Literacy Follow-up in Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Tailored Health Literacy follow-up in cancer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with cancer Above 18 years old Receiving treatment at the main intervention hospital Exclusion Criteria: Not diagnosed with cancer Not above 18 years old Not in treatment at the intervention hospital

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Intervention Group<br>The intervention group will receive a tailored intervention based on each individuals health literacy needs. A project nurse with broad experience in cancer care will be trained in Motivational Interviewing techniques to provide follow-up for the patients in the intervention group in a period of 9 months. | Behavioral: Tailored Health Literacy follow-up in cancer<br>* 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. Actions: Based on results of the consultation, the project nurse and the patient will use a worksheet of possible actions to identify those most relevant to the patient's individual needs. Based on this, different self-management tasks and actions will be offered, and an individual tailored follow-up plan will be made. The patient and the project nurse will use a workbook containing information on the follow-up plan that will be added into medical record. Telephone/digital conversations with the project every second month for a period of 9 months.<br>|
| No Intervention: Usual care group<br>Usual care group will receive usual follow-up. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Health literacy measured with the Health Literacy Questionnaire (HLQ) | Change of Health Literacy questionnaire | 6 months, 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electronic Health Literacy measured with the electronic Health Literacy Questionnaire (eHLQ) | Change of electronic Health Literacy questionnaire | 6 months, 9 months | 
| General symptoms measured with the Edmonton Symptom Assessment System (ESAS) | Change of symptom burden questionnaire | 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) | Change in oral symptoms | 6 months, 9 months | 
| Self-management measured with the Health Education Impact Questionnaire (HeiQ) | Change of self-management questionnaire | 6 months, 9 months | 
| Self-Efficacy measured with the General Self-efficacy Scale (GSE) | Change of Self-efficacy questionnaire | 6 months, 9 months | 
| Disease specific Quality of Life measured with the The functional Assessment of Cancer Therapy-General (FACT-G) | Change of quality of life questionnaire | 6 months, 9 months | 
| Generic health-related quality of life/quality adjusted life years measured by the EQ-5D | Change in health related quality of life and adjusted life years | 6 months, 9 months | 
| Health care costs measured through collecting data from patient medical records, patient self-report, and data registers | Change of health care costs | 6 months, 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health literacy