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NCT Number: NCT05627180

Tailored Health Literacy Follow-up in Cancer

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lovisenberg Diakonale Hospital

Oslo, 0440, Norway

Location status: Recruiting

Location contact

Marit Leine

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored Health Literacy follow-up in cancer

Behavioral
  • 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.

Primary outcomes

  1. General Health literacy measured with the Health Literacy Questionnaire (HLQ)

    Time frame: 6 months, 9 months

    Change of Health Literacy questionnaire

Secondary outcomes

  1. Electronic Health Literacy measured with the electronic Health Literacy Questionnaire (eHLQ)

    Time frame: 6 months, 9 months

    Change of electronic Health Literacy questionnaire

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

    Time frame: 6 months, 9 months

    Change of symptom burden questionnaire

  3. 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

    Change in oral symptoms

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

    Time frame: 6 months, 9 months

    Change of self-management questionnaire

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

    Time frame: 6 months, 9 months

    Change of Self-efficacy questionnaire

  6. Disease specific Quality of Life measured with the The functional Assessment of Cancer Therapy-General (FACT-G)

    Time frame: 6 months, 9 months

    Change of quality of life questionnaire

  7. Generic health-related quality of life/quality adjusted life years measured by the EQ-5D

    Time frame: 6 months, 9 months

    Change in health related quality of life and adjusted life years

  8. Health care costs measured through collecting data from patient medical records, patient self-report, and data registers

    Time frame: 6 months, 9 months

    Change of health care costs

Study contacts

Contact information is provided by the study sponsor or research team.

Christine R Borge, PhD

CONTACT

[email protected]

+47 23225000

Marit Leine, master

CONTACT

[email protected]

+47 23225000

Sponsors and collaborators

Lead sponsor

Lovisenberg Diakonale Hospital

Other

Collaborators

  • University of Oslo

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Nov 25, 2022
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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