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Recruiting NCT05627180

Tailored Health Literacy Follow-up in Cancer

No phase Interventional Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tailored Health Literacy follow-up in cancer.
Who it may be relevant to
Registry conditions: Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Behavioral Tailored 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 pa

Primary outcome measures

  • General Health literacy measured with the Health Literacy Questionnaire (HLQ) [Time frame: 6 months, 9 months]
Secondary outcome measures (8)
  • Electronic Health Literacy measured with the electronic Health Literacy Questionnaire (eHLQ) [Time frame: 6 months, 9 months]
  • General symptoms measured with the Edmonton Symptom Assessment System (ESAS) [Time frame: 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) [Time frame: 6 months, 9 months]
  • Self-management measured with the Health Education Impact Questionnaire (HeiQ) [Time frame: 6 months, 9 months]
  • Self-Efficacy measured with the General Self-efficacy Scale (GSE) [Time frame: 6 months, 9 months]
  • Disease specific Quality of Life measured with the The functional Assessment of Cancer Therapy-General (FACT-G) [Time frame: 6 months, 9 months]
  • Generic health-related quality of life/quality adjusted life years measured by the EQ-5D [Time frame: 6 months, 9 months]
  • Health care costs measured through collecting data from patient medical records, patient self-report, and data registers [Time frame: 6 months, 9 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Norway · 1 center
  • Lovisenberg Diakonale Hospital — Oslo

Identifiers

NCT: NCT05627180 · 341

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗