Tailored Health Literacy Follow-up in Cancer

NCT ID: NCT05627180

Last Updated: 2023-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-30

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators
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.

Study Groups

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The Intervention Group

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.

Group Type EXPERIMENTAL

Tailored Health Literacy follow-up in cancer

Intervention Type 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.

Usual care group

Usual care group will receive usual follow-up.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo

OTHER

Sponsor Role collaborator

Lovisenberg Diakonale Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christine Råheim Borge

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christine R Borge, PhD

Role: PRINCIPAL_INVESTIGATOR

Lovisenberg Diaconal Hospital and University of Oslo

Astrid K Wahl, PhD

Role: STUDY_CHAIR

University of Oslo

Simen A Steindal, PhD

Role: STUDY_CHAIR

VID

Locations

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Lovisenberg Diakonale Hospital

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Christine R Borge, PhD

Role: CONTACT

+47 23225000

Marit Leine, master

Role: CONTACT

+47 23225000

Facility Contacts

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Marit Leine

Role: primary

Other Identifiers

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341

Identifier Type: -

Identifier Source: org_study_id

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