Trial Outcomes & Findings for Health Literacy and Digital Health in Cancer Patients. (NCT NCT05070897)
NCT ID: NCT05070897
Last Updated: 2024-06-12
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
1518 participants
Primary outcome timeframe
1 month
Results posted on
2024-06-12
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
781
|
737
|
|
Overall Study
COMPLETED
|
658
|
669
|
|
Overall Study
NOT COMPLETED
|
123
|
68
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Protocol Violation
|
123
|
68
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Population A
n=781 Participants
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
|
Population B
n=737 Participants
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
|
Total
n=1518 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=781 Participants
|
0 Participants
n=737 Participants
|
0 Participants
n=1518 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=781 Participants
|
737 Participants
n=737 Participants
|
737 Participants
n=1518 Participants
|
|
Age, Categorical
>=65 years
|
781 Participants
n=781 Participants
|
0 Participants
n=737 Participants
|
781 Participants
n=1518 Participants
|
|
Age, Continuous
|
74.9 years
n=781 Participants
|
51.9 years
n=737 Participants
|
63.7 years
n=1518 Participants
|
|
Sex: Female, Male
Female
|
407 Participants
n=781 Participants
|
488 Participants
n=737 Participants
|
895 Participants
n=1518 Participants
|
|
Sex: Female, Male
Male
|
374 Participants
n=781 Participants
|
249 Participants
n=737 Participants
|
623 Participants
n=1518 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
781 participants
n=781 Participants
|
737 participants
n=737 Participants
|
1518 participants
n=1518 Participants
|
|
Living place
Home
|
763 Participants
n=781 Participants
|
721 Participants
n=737 Participants
|
1484 Participants
n=1518 Participants
|
|
Living place
Nursing home
|
6 Participants
n=781 Participants
|
3 Participants
n=737 Participants
|
9 Participants
n=1518 Participants
|
|
Living place
Other
|
7 Participants
n=781 Participants
|
6 Participants
n=737 Participants
|
13 Participants
n=1518 Participants
|
|
Living place
Missing
|
5 Participants
n=781 Participants
|
7 Participants
n=737 Participants
|
12 Participants
n=1518 Participants
|
|
Do you live alone?
Yes
|
243 Participants
n=781 Participants
|
159 Participants
n=737 Participants
|
402 Participants
n=1518 Participants
|
|
Do you live alone?
No
|
531 Participants
n=781 Participants
|
565 Participants
n=737 Participants
|
1096 Participants
n=1518 Participants
|
|
Do you live alone?
Missing
|
7 Participants
n=781 Participants
|
13 Participants
n=737 Participants
|
20 Participants
n=1518 Participants
|
|
Area of residence
Urban
|
439 Participants
n=781 Participants
|
385 Participants
n=737 Participants
|
824 Participants
n=1518 Participants
|
|
Area of residence
Rural
|
287 Participants
n=781 Participants
|
288 Participants
n=737 Participants
|
575 Participants
n=1518 Participants
|
|
Area of residence
Missing
|
55 Participants
n=781 Participants
|
64 Participants
n=737 Participants
|
119 Participants
n=1518 Participants
|
|
Help for daily activites (neighbour, family, friends, medical professional)
Yes
|
465 Participants
n=781 Participants
|
479 Participants
n=737 Participants
|
944 Participants
n=1518 Participants
|
|
Help for daily activites (neighbour, family, friends, medical professional)
No
|
246 Participants
n=781 Participants
|
206 Participants
n=737 Participants
|
452 Participants
n=1518 Participants
|
|
Help for daily activites (neighbour, family, friends, medical professional)
Missing
|
70 Participants
n=781 Participants
|
52 Participants
n=737 Participants
|
122 Participants
n=1518 Participants
|
|
Cancer status
Localised
|
233 Participants
n=781 Participants
|
286 Participants
n=737 Participants
|
519 Participants
n=1518 Participants
|
|
Cancer status
Advanced and/or metastatic
|
547 Participants
n=781 Participants
|
448 Participants
n=737 Participants
|
995 Participants
n=1518 Participants
|
|
Cancer status
Not documented
|
1 Participants
n=781 Participants
|
2 Participants
n=737 Participants
|
3 Participants
n=1518 Participants
|
|
Cancer status
Missing
|
0 Participants
n=781 Participants
|
1 Participants
n=737 Participants
|
1 Participants
n=1518 Participants
|
PRIMARY outcome
Timeframe: 1 monthHealth 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.
Outcome measures
| Measure |
Population A
n=658 Participants
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
|
Population B
n=669 Participants
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
|
|---|---|---|
|
Percentage of Participants With an Overall Score of ≤ 4 on the FCCHL Scale.
|
518 Participants
|
468 Participants
|
SECONDARY outcome
Timeframe: 1 monthThe 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.
Outcome measures
| Measure |
Population A
n=781 Participants
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
|
Population B
n=737 Participants
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
|
|---|---|---|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use of internet · Never
|
232 Participants
|
39 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use of internet · Rarely
|
26 Participants
|
17 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use of internet · Sometimes
|
64 Participants
|
43 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use of internet · Often
|
156 Participants
|
133 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use of internet · Always
|
284 Participants
|
493 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use of internet · Not available
|
19 Participants
|
12 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use of internet for you health · Never
|
321 Participants
|
100 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use of internet for you health · Rarely
|
67 Participants
|
62 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use of internet for you health · Sometimes
|
152 Participants
|
179 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use of internet for you health · Often
|
128 Participants
|
231 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use of internet for you health · Always
|
86 Participants
|
149 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use of internet for you health · Not available
|
27 Participants
|
16 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Communication by email in daily life · Never
|
278 Participants
|
76 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Communication by email in daily life · Rarely
|
35 Participants
|
36 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Communication by email in daily life · Sometimes
|
81 Participants
|
88 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Communication by email in daily life · Often
|
154 Participants
|
203 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Communication by email in daily life · Always
|
215 Participants
|
323 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Communication by email in daily life · Not available
|
18 Participants
|
11 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a smartphone (with internet connection and applications) · Never
|
146 Participants
|
36 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a smartphone (with internet connection and applications) · Rarely
|
21 Participants
|
6 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a smartphone (with internet connection and applications) · Sometimes
|
45 Participants
|
13 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a smartphone (with internet connection and applications) · Often
|
91 Participants
|
62 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a smartphone (with internet connection and applications) · Always
|
460 Participants
|
612 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a smartphone (with internet connection and applications) · Not available
|
18 Participants
|
8 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Communication by texts in daily life · Never
|
199 Participants
|
29 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Communication by texts in daily life · Rarely
|
35 Participants
|
10 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Communication by texts in daily life · Sometimes
|
70 Participants
|
40 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Communication by texts in daily life · Often
|
147 Participants
|
139 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Communication by texts in daily life · Always
|
316 Participants
|
510 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Communication by texts in daily life · Not available
|
14 Participants
|
9 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a touch pad in daily life · Never
|
454 Participants
|
265 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a touch pad in daily life · Rarely
|
34 Participants
|
59 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a touch pad in daily life · Sometimes
|
46 Participants
|
81 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a touch pad in daily life · Often
|
62 Participants
|
94 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a touch pad in daily life · Always
|
167 Participants
|
223 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a touch pad in daily life · Not available
|
18 Participants
|
15 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a computer in daily life · Never
|
274 Participants
|
78 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a computer in daily life · Rarely
|
34 Participants
|
35 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a computer in daily life · Sometimes
|
56 Participants
|
77 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a computer in daily life · Often
|
110 Participants
|
165 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a computer in daily life · Always
|
292 Participants
|
368 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a computer in daily life · Not available
|
15 Participants
|
14 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a medical apps (on pad or smartphone) · Never
|
593 Participants
|
367 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a medical apps (on pad or smartphone) · Rarely
|
56 Participants
|
103 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a medical apps (on pad or smartphone) · Sometimes
|
69 Participants
|
113 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a medical apps (on pad or smartphone) · Often
|
26 Participants
|
87 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a medical apps (on pad or smartphone) · Always
|
22 Participants
|
55 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use a medical apps (on pad or smartphone) · Not available
|
15 Participants
|
12 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use connected objects (e.g. connected swatch, pedometer, etc.) · Never
|
650 Participants
|
512 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use connected objects (e.g. connected swatch, pedometer, etc.) · Rarely
|
29 Participants
|
46 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use connected objects (e.g. connected swatch, pedometer, etc.) · Sometimes
|
21 Participants
|
58 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use connected objects (e.g. connected swatch, pedometer, etc.) · Often
|
33 Participants
|
55 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use connected objects (e.g. connected swatch, pedometer, etc.) · Always
|
34 Participants
|
60 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use connected objects (e.g. connected swatch, pedometer, etc.) · Not available
|
14 Participants
|
6 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use online consultations or telemedicine · Never
|
647 Participants
|
472 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use online consultations or telemedicine · Rarely
|
54 Participants
|
87 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use online consultations or telemedicine · Sometimes
|
50 Participants
|
120 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use online consultations or telemedicine · Often
|
6 Participants
|
29 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use online consultations or telemedicine · Always
|
12 Participants
|
20 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Use online consultations or telemedicine · Not available
|
12 Participants
|
9 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Change yours habits and use online consultations or telemedicine since the beginning of COVID-19? · Never
|
642 Participants
|
469 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Change yours habits and use online consultations or telemedicine since the beginning of COVID-19? · Rarely
|
61 Participants
|
91 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Change yours habits and use online consultations or telemedicine since the beginning of COVID-19? · Sometimes
|
36 Participants
|
105 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Change yours habits and use online consultations or telemedicine since the beginning of COVID-19? · Often
|
18 Participants
|
42 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Change yours habits and use online consultations or telemedicine since the beginning of COVID-19? · Always
|
13 Participants
|
23 Participants
|
|
Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
Change yours habits and use online consultations or telemedicine since the beginning of COVID-19? · Not available
|
11 Participants
|
7 Participants
|
Adverse Events
Population A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Population B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place