Health Literacy and Digital Health in Cancer Patients. (LICAPA)

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Questionnaires

• Study Type: Observational
• Enrollment (Actual): 1518

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Pr Elene Paillaud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients seen in an oncology, or oncogeriatric consultation or treated in an oncology or geriatric outpatient clinic (not including full hospitalisation lasting ≥ 24h).

Description

Inclusion Criteria:

1. Man or woman.
2. Age ≥ 18 years.
3. Patient treated for cancer.
4. Patient who can read and understand French.
5. Patient seen in an oncology or oncogeriatric consultation or treated in an outpatient clinic.
6. 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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Population A; 65 years old and more	Other: Questionnaires; Approved French version of the FCCHL scale; Questionnaire on the use of digital tools adapted from the questionnaire on digital tools
Population B; 18 to 64 years old	Other: Questionnaires; Approved French version of the FCCHL scale; Questionnaire on the use of digital tools adapted from the questionnaire on digital tools

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With an Overall Score of ≤ 4 on the FCCHL Scale.	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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.	The questionnaire on the use of digital tools will be described per item: This questionnaire includes 10 items.; A Likert-type scale with five modalities of response is proposed (never, rarely, sometimes, often, always).; No overall score will be calculated.	1 month

Collaborators and Investigators

• Sponsor: Institut Bergonié

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Actual): November 8, 2021
• Study Completion (Actual): December 16, 2021

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 7, 2021

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Health literacy; Digital health
• Other Study ID Numbers: IB 2021-04; 2021-A01725-36 (Other Identifier: ID-RCB number ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No