Clinical trial NCT05627180: Tailored Health Literacy Follow-up in Cancer
Official title: Tailored Health Literacy Follow-up in Cancer - the Tail HealthLit Cancer Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Health literacy
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2022-11-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: General Health literacy measured with the Health Literacy Questionnaire (HLQ)
timeFrame: 6 months, 9 months
Secondary outcomes:
measure: Electronic Health Literacy measured with the electronic Health Literacy Questionnaire (eHLQ)
timeFrame: 6 months, 9 months
measure: General symptoms measured with the Edmonton Symptom Assessment System (ESAS)
timeFrame: 6 months, 9 months
measure: Oral symptoms measured with four items selected from the European Organization for REsearch and Treatment of Cancer-oral health 15 (EORTC-OH 15)
timeFrame: 6 months, 9 months
measure: Self-management measured with the Health Education Impact Questionnaire (HeiQ)
timeFrame: 6 months, 9 months
measure: Self-Efficacy measured with the General Self-efficacy Scale (GSE)
timeFrame: 6 months, 9 months
measure: Disease specific Quality of Life measured with the The functional Assessment of Cancer Therapy-General (FACT-G)
timeFrame: 6 months, 9 months
measure: Generic health-related quality of life/quality adjusted life years measured by the EQ-5D
timeFrame: 6 months, 9 months
measure: Health care costs measured through collecting data from patient medical records, patient self-report, and data registers
timeFrame: 6 months, 9 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Lovisenberg Diakonale Hospital
Study officials:
affiliation: Lovisenberg Diaconal Hospital and University of Oslo
name: Christine R Borge, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oslo
name: Astrid K Wahl, PhD
role: STUDY_CHAIR
affiliation: VID
name: Simen A Steindal, PhD
role: STUDY_CHAIR
References: