Tailored Health Literacy Follow-up in Cancer

NCT05627180 | Recruiting

• 1 other identifier: 341
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Health literacy

Outcome Measures

Primary Outcomes (1)

• General Health literacy measured with the Health Literacy Questionnaire (HLQ)

  Change of Health Literacy questionnaire

  6 months, 9 months

Secondary Outcomes (8)

• Electronic Health Literacy measured with the electronic Health Literacy Questionnaire (eHLQ)

  6 months, 9 months

• General symptoms measured with the Edmonton Symptom Assessment System (ESAS)

  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)

  6 months, 9 months

• Self-management measured with the Health Education Impact Questionnaire (HeiQ)

  6 months, 9 months

• Self-Efficacy measured with the General Self-efficacy Scale (GSE)

  6 months, 9 months

Study Arms (2)

The Intervention Group

EXPERIMENTAL

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

Usual care group

NO INTERVENTION

Usual care group will receive usual follow-up.

Interventions

Tailored Health Literacy follow-up in cancer BEHAVIORAL

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 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. 3. Telephone/digital conversations with the project every second month for a period of 9 months.

The Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lovisenberg Diakonale Hospital: lead
• University of Oslo: collaborator

Study Sites (1)

Lovisenberg Diakonale Hospital

Oslo, 0440, Norway

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Christine R Borge, PhD

  Lovisenberg Diaconal Hospital and University of Oslo

  PRINCIPAL INVESTIGATOR

• Astrid K Wahl, PhD

  University of Oslo

  STUDY CHAIR

• Simen A Steindal, PhD

  VID

  STUDY CHAIR

Central Study Contacts

Christine R Borge, PhD

CONTACT

+47 23225000; chrr@lds.no

Marit Leine, master

CONTACT

+47 23225000; marit.leine@lds.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 25, 2022
• Study Start: March 30, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)