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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01725-36 | Other Identifier | ID-RCB number ANSM |
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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:
The following questionnaires:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Population A | 65 years old and more |
| |
| Population B | 18 to 64 years old |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other |
|
|
| 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 |
| 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:
| 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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Patients seen in an oncology, or oncogeriatric consultation or treated in an oncology or geriatric outpatient clinic (not including full hospitalisation lasting ≥ 24h).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pr Elene Paillaud | Paris | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Population A | 65 years old and more ... Questionnaires: • Approved French version of the FCCHL scale • Questionnaire on the use of digital tools adapted from the questionnaire on digital tools |
| FG001 | Population B | 18 to 64 years old ... Questionnaires: • Approved French version of the FCCHL scale • Questionnaire on the use of digital tools adapted from the questionnaire on digital tools |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Population A | 65 years old and more Questionnaires: • Approved French version of the FCCHL scale • Questionnaire on the use of digital tools adapted from the questionnaire on digital tools |
| BG001 | Population B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 1 month |
|
Adverse events were not collected for this study
Adverse events were not collected for this study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Population A | 65 years old and more Questionnaires: • Approved French version of the FCCHL scale • Questionnaire on the use of digital tools adapted from the questionnaire on digital tools |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Elena Paillaud | Hôpital Européen Georges Pompidou | 0156093310 | elena.paillaud@aphp.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 18, 2021 | May 13, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 5, 2021 | May 13, 2024 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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18 to 64 years old
Questionnaires: • Approved French version of the FCCHL scale
• Questionnaire on the use of digital tools adapted from the questionnaire on digital tools
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Living place | Count of Participants | Participants |
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| Do you live alone? | Count of Participants | Participants |
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| Area of residence | Count of Participants | Participants |
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| Help for daily activites (neighbour, family, friends, medical professional) | Count of Participants | Participants |
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| Cancer status | Count of Participants | Participants |
|
| OG000 |
| Population A |
65 years old and more Questionnaires: • Approved French version of the FCCHL scale • Questionnaire on the use of digital tools adapted from the questionnaire on digital tools |
| OG001 | Population B | 18 to 64 years old Questionnaires: • Approved French version of the FCCHL scale • Questionnaire on the use of digital tools adapted from the questionnaire on digital tools |
|
|
| Secondary | 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:
| Posted | Count of Participants | Participants | 1 month |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Population B | 18 to 64 years old Questionnaires: • Approved French version of the FCCHL scale • Questionnaire on the use of digital tools adapted from the questionnaire on digital tools | 0 | 0 | 0 | 0 | 0 | 0 |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Other |
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| Missing |
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| Missing |
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| Missing |
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| Missing |
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| Not documented |
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| Missing |
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| Sometimes |
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| Often |
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| Always |
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| Not available |
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| Use of internet for you health |
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| Communication by email in daily life |
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| Use a smartphone (with internet connection and applications) |
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| Communication by texts in daily life |
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| Use a touch pad in daily life |
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| Use a computer in daily life |
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| Use a medical apps (on pad or smartphone) |
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| Use connected objects (e.g. connected swatch, pedometer, etc.) |
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| Use online consultations or telemedicine |
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| Change yours habits and use online consultations or telemedicine since the beginning of COVID-19? |
|