Tailored Health Literacy Follow-up in Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Tailored Health Literacy follow-up in cancer

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine R Borge, PhD; Phone Number: +47 23225000; Email: chrr@lds.no
• Study Contact Backup: Name: Marit Leine, master; Phone Number: +47 23225000; Email: marit.leine@lds.no

Study Locations

• Norway
  • Oslo, Norway, 0440
    • Recruiting
    • Lovisenberg Diakonale Hospital
    • Contact: Marit Leine; Email: marit.leine@lds.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Intervention Group; 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; 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.
No Intervention: Usual care group; Usual care group will receive usual follow-up.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lovisenberg Diakonale Hospital
• Collaborators: University of Oslo
• Investigators: Principal Investigator: Christine R Borge, PhD, Lovisenberg Diaconal Hospital and University of Oslo; Study Chair: Astrid K Wahl, PhD, University of Oslo; Study Chair: Simen A Steindal, PhD, VID

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): November 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Health literacy
• Other Study ID Numbers: 341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No