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Tailored Health Literacy Follow-up in Cancer

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05627180
Enrollment
150
Registered
2022-11-25
Start date
2023-03-30
Completion date
2026-12-31
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Health literacy

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.

Interventions

BEHAVIORALTailored Health Literacy follow-up in cancer

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.

Sponsors

University of Oslo
CollaboratorOTHER
Lovisenberg Diakonale Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
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.

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
General Health literacy measured with the Health Literacy Questionnaire (HLQ)6 months, 9 monthsChange of Health Literacy questionnaire

Secondary

MeasureTime frameDescription
Electronic Health Literacy measured with the electronic Health Literacy Questionnaire (eHLQ)6 months, 9 monthsChange of electronic Health Literacy 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 monthsChange in oral symptoms
Self-management measured with the Health Education Impact Questionnaire (HeiQ)6 months, 9 monthsChange of self-management questionnaire
General symptoms measured with the Edmonton Symptom Assessment System (ESAS)6 months, 9 monthsChange of symptom burden questionnaire
Disease specific Quality of Life measured with the The functional Assessment of Cancer Therapy-General (FACT-G)6 months, 9 monthsChange of quality of life questionnaire
Generic health-related quality of life/quality adjusted life years measured by the EQ-5D6 months, 9 monthsChange 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 registers6 months, 9 monthsChange of health care costs
Self-Efficacy measured with the General Self-efficacy Scale (GSE)6 months, 9 monthsChange of Self-efficacy questionnaire

Countries

Norway

Contacts

Primary ContactChristine R Borge, PhD
chrr@lds.no+47 23225000
Backup ContactMarit Leine, master
marit.leine@lds.no+47 23225000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026