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Clinical Trials/NCT05070897
NCT05070897
Completed
Not Applicable

Health Literacy and Digital Health in Cancer Patients.

Institut Bergonié1 site in 1 country1,518 target enrollmentSeptember 27, 2021
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Institut Bergonié
Enrollment
1518
Locations
1
Primary Endpoint
Percentage of Participants With an Overall Score of ≤ 4 on the FCCHL Scale.
Status
Completed
Last Updated
last year

Overview

Brief Summary

This is a multicentric, prospective, observational, transversal study, aiming to evaluate the health literacy of cancer patients using the approved French version of the Functional, Communicative and Critical Health Literacy (FCCHL) scale in 2 populations:

  • Population A: patients age 65 and over treated in an oncology or oncogeriatric outpatient clinic, or seen in an oncology or oncogeriatric consultation.
  • Population B: young patients age 18 to 64 treated in an oncology or outpatient clinic, or seen in an oncology consultation.

The following questionnaires:

  • Approved French version of the FCCHL scale
  • Questionnaire on the use of digital tools adapted from the questionnaire on digital tools,

will be completed once only. It will be completed by the participant during the oncology or oncogeriatric consultation or outpatient clinic appointment, in self-questionnaire mode or face to face, assisted if necessary by a family member or member of the medical team.

Registry
clinicaltrials.gov
Start Date
September 27, 2021
End Date
December 16, 2021
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Man or woman.
  • Age ≥ 18 years.
  • Patient treated for cancer.
  • Patient who can read and understand French.
  • Patient seen in an oncology or oncogeriatric consultation or treated in an outpatient clinic.
  • Patient in treatment or about to start treatment that has been offered to them, from the announcement consultation to 2 years after the start of treatment

Exclusion Criteria

  • Patient hospitalised for longer than 24 hours.
  • Patient with know cognitive impairment preventing them from answering the questionnaire.

Outcomes

Primary Outcomes

Percentage of Participants With an Overall Score of ≤ 4 on the FCCHL Scale.

Time Frame: 1 month

Health literacy of cancer patients using the approved French version of the Functional, Communicative and Critical Health Literacy (FCCHL) scale. The FCCHL questionnaire includes 14 items, divided into 3 sub-scales, reflecting 3 health literacy skills (functional literacy, interactive literacy and critical literacy). The overall score will be calculated by determining the mean score for the 3 sub-scales. A score of ≤ 4 on the FCCHL scale, corresponds to a low level of health literacy. Each item of the FCCHL takes a score of 1 to 5 points. For each patient, a literacy score per sub-scale will be determined by calculating the number of points divided by the number of items on the sub-scale. The score can range from 1 to 5. The overall literacy score will be calculated as the mean of the 3 sub-scales. This score can range from 1 to 5. For functional scale, higher value represent worse outcome and for the other scale, a higher value represent a better outcome.

Secondary Outcomes

  • Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.(1 month)

Study Sites (1)

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