Tailored Health Literacy Follow-up in Cancer

Sponsor

Lovisenberg Diakonale Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05627180

Collaborator

University of Oslo (Other)

150

Enrollment

Location

Arms

47.9

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Behavioral: Tailored Health Literacy follow-up in cancer	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trialRandomized controlled trial

Masking:

Single (Investigator)

Masking Description:

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.

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jan 2, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

General Health literacy measured with the Health Literacy Questionnaire (HLQ) [6 months, 9 months]
Change of Health Literacy questionnaire

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lovisenberg Diakonale Hospital	Oslo		Norway	0440

Sponsors and Collaborators

Lovisenberg Diakonale Hospital
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christine Råheim Borge, Researcher, Lovisenberg Diakonale Hospital

ClinicalTrials.gov Identifier:

NCT05627180

Other Study ID Numbers:

First Posted:

Nov 25, 2022

Last Update Posted:

Nov 25, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Christine Råheim Borge, Researcher, Lovisenberg Diakonale Hospital

Health literacy

Study Results

No Results Posted as of Nov 25, 2022