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OpenTrials
Completed

NCT Number: NCT05070897

Health Literacy and Digital Health in Cancer Patients.

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pr Elene Paillaud

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

questionnaires

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

Primary outcomes

  1. 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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Acronym: LICAPA

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 7, 2021
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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