Tailored Health Literacy Follow-up in Cancer

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05627180
• Other study ID #: 341
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2023
• Source: Lovisenberg Diakonale Hospital
• Contact: Christine R Borge, PhD
• Phone: +47 23225000
• Email: chrr[@]lds.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
Norway	Lovisenberg Diakonale Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Lovisenberg Diakonale Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General Health literacy measured with the Health Literacy Questionnaire (HLQ)	Change of Health Literacy questionnaire	6 months, 9 months
Secondary	Electronic Health Literacy measured with the electronic Health Literacy Questionnaire (eHLQ)	Change of electronic Health Literacy questionnaire	6 months, 9 months
Secondary	General symptoms measured with the Edmonton Symptom Assessment System (ESAS)	Change of symptom burden questionnaire	6 months, 9 months
Secondary	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
Secondary	Self-management measured with the Health Education Impact Questionnaire (HeiQ)	Change of self-management questionnaire	6 months, 9 months
Secondary	Self-Efficacy measured with the General Self-efficacy Scale (GSE)	Change of Self-efficacy questionnaire	6 months, 9 months
Secondary	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
Secondary	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
Secondary	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