CancerLICAPANCT05070897
Health Literacy and Digital Health in Cancer Patients.
An observational study of Cancer, run by Institut Bergonié at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Questionnaires
- How many people
- 1,518 participants
- Where
- 1 siteFrance
- Study dates
- 27 Sep 2021to 16 Dec 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Patient hospitalised for longer than 24 hours.
- Patient with know cognitive impairment preventing them from answering the questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Questionnaires
- Keywords
- Health literacy, Digital health
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
- Approved French version of the FCCHL scale
- Questionnaire on the use of digital tools adapted from the questionnaire on digital tools
| Study group | Role | What they receive |
|---|---|---|
| Population A | 65 years old and more Receives: Other: Questionnaires | |
| Population B | 18 to 64 years old Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start27 Sep 2021
- Primary completion8 Nov 2021
- Study completion16 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070897
- Sponsor's protocol ID
- IB 2021-04
- Other IDs
- 2021-A01725-36
- Acronym
- LICAPA
- Status last verified
- Oct 2023
- First submitted
- 23 Sep 2021
- Last updated
- 12 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Literacy and Digital Health in Cancer Patients.
- ClinicalTrials.gov ID
- NCT05070897
- Acronym / sponsor ID
- LICAPA / IB 2021-04
- Conditions
- Cancer
- Keywords
- Health literacy, Digital health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,518 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 7 Oct 2021 (actual)
- Results
- Posted 12 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Population A | – | Other: Questionnaires65 years old and more |
| Population B | – | Other: Questionnaires18 to 64 years old |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Patient hospitalised for longer than 24 hours.
- Patient with know cognitive impairment preventing them from answering the questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires* Approved French version of the FCCHL scale * Questionnaire on the use of digital tools adapted from the questionnaire on digital tools | Other | Population A, Population B |
Primary outcome
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.
1 secondary outcome
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With an Overall Score of ≤ 4 on the FCCHL Scale. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.