LICAPA: Health Literacy and Digital Health in Cancer Patients.

Sponsor
Institut Bergonié (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05070897
Collaborator
(none)
840
Enrollment
4.2
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Questionnaires

Study Design

Study Type:
Observational
Anticipated Enrollment :
840 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Health Literacy and Digital Health in Cancer Patients.
Anticipated Study Start Date :
Sep 27, 2021
Anticipated Primary Completion Date :
Nov 27, 2021
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Population A

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

Population B

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

Outcome Measures

Primary Outcome Measures

  1. Percentage of participants with an overall score of ≤ 4 on the FCCHL scale. [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.

Secondary Outcome Measures

  1. Number et percentage of participants by items of the questionnaire on the use of digital Tools. [1 month]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Institut Bergonié

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT05070897
Other Study ID Numbers:
  • IB 2021-04
  • 2021-A01725-36
First Posted:
Oct 7, 2021
Last Update Posted:
Oct 7, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut Bergonié

Study Results

No Results Posted as of Oct 7, 2021