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Trial Title:
Tailored Health Literacy Follow-up in Cancer
NCT ID:
NCT05627180
Condition:
Cancer
Conditions: Keywords:
Health literacy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized controlled trial
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:
Intervention type:
Behavioral
Intervention name:
Tailored Health Literacy follow-up in cancer
Description:
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.
Arm group label:
The Intervention Group
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Lovisenberg Diakonale Hospital
Address:
City:
Oslo
Zip:
0440
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Marit Leine
Email:
marit.leine@lds.no
Start date:
March 30, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Lovisenberg Diakonale Hospital
Agency class:
Other
Collaborator:
Agency:
University of Oslo
Agency class:
Other
Source:
Lovisenberg Diakonale Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05627180
