Health Literacy and Digital Health in Cancer Patients.

NCT05070897 | Completed Results

• 2 other identifiers: IB 2021-042021-A01725-36
• Study Type: observational
• Target: 1,518
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Health literacy; Digital health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.

  1 month

Study Arms (2)

Population A

65 years old and more

Other: Questionnaires

Population B

18 to 64 years old

Other: Questionnaires

Interventions

Questionnaires OTHER

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

Population A; Population B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (1)

Pr Elene Paillaud

Paris, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Pr Elena Paillaud
• Organization: Hôpital Européen Georges Pompidou

elena.paillaud@aphp.fr

0156093310

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 7, 2021
• Study Start: September 27, 2021
• Primary Completion: November 8, 2021
• Study Completion: December 16, 2021
• Last Updated: June 12, 2024
• Results First Posted: April 12, 2024

Record last verified: 2023-10

Locations

FR (1)