Health Literacy and Digital Health in Cancer Patients.
Conditions: Cancer
Sponsor: Institut Bergonié

       
        
 
Version no. 1.0 dated 18/06/2021  
 
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Health literacy and digital health in cancer 
patients  
“LICAPA” study 
 
Study type according to French Law : Category 3 Non-Interventional Human Research Study 
(RIPH 3) 
  
According to the French Law & French regulatory authorities :  
this is considered as a Non-Interventional Human Research Study, of category -3 (RIPH-3).  
As such, a full study protocol is NOT REQUIRED : 
French authorities only require a protocol summary. 
 
Protocol summary 
 
Version no. 1.0 dated 18/06/2021 
 
IB no. 2021-04 
 
ID-RCB no. 2021-A01725-36 
 
This research is backed by the elderly and cancer clinical research platform (Plateforme de Recherche 
Clinique Personnes Agées et Cancer - PACAN) 
 
 
Study coordinator 
Prof. Elena Paillaud 
Geriatric Department 
PACAN Co-Coordinator 
Paris Ouest Oncogeriatrics coordination unit  
 
Hôpital Européen Georges Pompidou 
 
20, rue Leblanc - 75908 PARIS CEDEX 15 
 
Tel.: 01.56.09.33.10 – E-mail: elena.paillaud@aphp.fr 
Scientific managers 
Prof. Simone Mathoulin-Pelissier,  PACAN Coordinator, 
 Institut Bergonié 
Prof. Pierre-Louis Soubeyran, PACAN Co-coordinator, 
 Institut Bergonié 
Clinical Research and Epidemiology Unit 
Prof. Simone Mathoulin-Pelissier,  Unit Head 
 Institut Bergonié 
Marina Pulido, Methodology statistician 
Institut Bergonié 
Caroline Lalet, Clinical studies manager 
Institut Bergonié 
Inserm U1219 Epicene team 
Angéline Galvin, Epidemiologist                                                                                         Université Bordeaux 
SPONSOR 
INSTITUT BERGONIÉ 
 
229 cours de l’Argonne 
 
33076 BORDEAUX Cedex 
 
Tel.: 05.56.33.33.33 – E-mail: drci@bordeaux.unicancer.fr 
 

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LICAPA Abstract 
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ABSTRACT 
TITLE 
Health literacy and digital health in cancer patients 
SHORT TITLE 
LiCaPa 
SPONSOR 
Institut Bergonié, Bordeaux       
COORDINATOR 
Prof. Elena Paillaud 
Hôpital Européen Georges Pompidou, AP-HP, Paris 
SCIENTIFIC MANAGERS 
Prof. Simone Mathoulin-Pelissier, Institut Bergonié, Bordeaux  Institut 
Bergonié 
Prof. Pierre-Louis Soubeyran, Institut Bergonié, Bordeaux 
  
JUSTIFICATION / BACKGROUND 
Health literacy can be defined as “people’s knowledge, motivation and 
competence to access, understand, appraise, and apply health 
information to make judgements and take decisions in everyday life 
concerning healthcare, disease prevention and health promotion to 
maintain or improve quality-of-life during the course of life”.  
In his literacy model, Nutbeam defines 3 skills, namely: i) functional 
health literacy which is sufficient basic skills in reading and writing to 
be able to function effectively in everyday situations, ii) communicative 
literacy which refers to more advanced skills which can be used to 
extract information and derive meaning from different forms of 
communication, and to apply new information to changing 
circumstances, and, iii) critical literacy which refers to more advanced 
cognitive skills which can be applied to critically analyse information, 
and to use this information to exert greater control over life events and 
situations.  
 
In a world in which information is delivered more and more via digital 
tools, digital health literacy is coming to play an increasingly important 
part. It is based on three skills that are skills in healthcare, information 
skills and digital skills.  
Low health literacy, whether digital or not, can represent a loss of 
chance in terms of health [2]. Several studies have demonstrated an 
association between health literacy and different events such as 
hospitalisations, understanding prescriptions, quality-of-life or even 
death.  
Given its consequences in terms of health, health literacy represents a 
determining element of public health, which can be acted on. In effect, 
taking account of health literacy is likely to improve the patient’s 
engagement, informed decision-making and final impact on health. 
However, the level of health literacy is preoccupying, especially in 
Europe and including in France.  
Whereas cancers represent a high cause of morbidity and mortality 
worldwide, and especially in France, few studies have looked at health 
literacy in cancer patients and at its consequences. According to the 
Institut National du Cancer (INCa), cancer in the over 65s represented 
62.4% of estimated cancers among all ages in 2017.  
As a result, close attention must be paid to information provided to the 
elderly to empower them to become fully involved in their treatment. 
Management of cancer in the elderly is specific due to the potential 
presence of various areas of fragility related to the person’s age and 
the extent of the concomitant diseases. People age 65 and older are 
therefore considered among the populations likely to find themselves 

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in difficulty due to their low level of health literacy, especially digital 
literacy.  
 
A pilot feasibility study was conducted in 2019 in people age 65 and 
over with cancer and treated in consultation or in the outpatient clinic 
in 6 volunteer centres in France. Overall, 72% of patients had a low level 
of health literacy. These results, which demonstrate low health literacy 
in elderly cancer patients, remain however preliminary. A larger study 
also including a control population of adults age 18 to 64 years is 
required.  
 
This multicentric transversal study will be the first to our knowledge. 
Health literacy in this population has never before been evaluated 
prospectively and the proportion presenting with a low level of health 
literacy was not known.  
OBJECTIVES 
Primary objective:  
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. 
 
Secondary objectives 
 
Describe the digital health literacy of patients per population. 
 
Identify groups with low health literacy and evaluate the 
related factors (age, sex, lifestyle etc.). 
 
Explore the factors related to the use of the digital. 
STUDY ORGANISATION 
Study design 
Multicentric, prospective, observational, transversal study. 
 
Study questionnaire methodology 
The questionnaire (Annex 1) including: 
 
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. 
 
There will be no specific interview, and the patient’s participation in the 
study shall not lead to any inconvenience or affect their treatment in 
any way. 
RESEARCH IMPLEMENTATION 
Expected number of centres  
Around 20 participating centres. 
 
Study duration  
o Inclusion time: 2 weeks between September and October 2021 
o Participation time for each patient: < 1 hour 
o Total study duration: 2 months 

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Methods of recruitment of persons questioned  
Patients seen in an oncology, or oncogeriatric consultation or treated 
in an oncology or geriatric outpatient clinic (not including full 
hospitalisation lasting ≥ 24h). 
 
Methods of information and tracing of consent  
The information leaflet (Annex 2) will be handed to the patient by the 
investigator who will state the patient’s consent to participate in the 
study in their medical record. 
INCLUSION CRITERIA 
1. Man or woman. 
2. Age ≥ 18 years. 
3. Patient treated for cancer. 
4. Patient who can read and understand French. 
5. Patient seen in an oncology or oncogeriatric consultation or treated 
in an outpatient clinic. 
6. 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 
1. Patient hospitalised for longer than 24 hours. 
2. Patient with know cognitive impairment preventing them from 
answering the questionnaire. 
OUTCOME MEASURES 
Primary endpoint: 
The primary endpoint is the percentage of participants with an overall 
score of ≤ 4 on the FCCHL scale, corresponding to a low level of health 
literacy: 
 The FCCHL questionnaire includes 14 items, divided into 3 sub-
scales, reflecting 3 health literacy skills (functional literacy, 
interactive literacy and critical literacy). 
 The FCCHL is validated and a French translation is available. 
 The scores for the three sub-scales are described for each 
population, and an overall score will be calculated by 
determining the mean score for the 3 sub-scales. 
 An overall score of ≤ 4  points to a low level of literacy. 
Secondary endpoints: 
The secondary endpoints include:  
 
The questionnaire on the use of digital tools will be described 
per item: 
o This questionnaire includes 10 items. 
o A Likert-type scale with five  modalities of response is 
proposed (never, rarely, sometimes, often, always). 
o No overall score will be calculated. 
 
The responses to the FCCHL scales and to the questionnaire on 
the use of the digital will also be described by sub-groups 
defined according to the patient’s characteristics at baseline 
(age, sex, lifestyle, etc.). 
STUDY SIZE 
Total: 840 patients  
- 
Population A: 420 patients 
- 
Population B: 420 patients 
 
The primary endpoint is the percentage of participants with an 
overall score of ≤ 4 on the FCCHL scale, evaluated in 2 populations: 

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- 
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. 
 
We plan to include around 300 eligible and assessable patients (overall 
score available) for the primary endpoint in each of the two populations 
(A and B). A total of 420 patients per population will be included in 
this study in order to take account of 40% of non-eligible/non-
assessable patients (score not available – 35% of patients had not fully 
completed the questionnaire in the feasibility study). Inclusion will last 
2 whole weeks, between September and October 2021, in 21 centres 
which will include at least 40 patients each.  
 
Our primary objective is to describe the percentage of patients with low 
health literacy, corresponding to an overall score of ≤ 4 on the FCCHL 
scale. We found an overall score of ≤ 4 for 72% of the patients in our 
feasibility study. Also, according to the latest report from the OECD, 
60% of French adults have a low level of literacy. Finally, around 88% of 
the elderly in Canada have a low level of health literacy compared to 
60% of adults. 
In each of the two populations, presuming 300 subjects are recruited 
for whom the overall score will be available, below we provide the 
precision of the estimations according to the expected percentage of 
subjects with a low level of literacy, between 60% and 90%. This 
percentage was calculated using the Wald test (normal approximation) 
(NQuery). 
Expected 
percenta
ge 
Precision CI width 
95% confidence interval 
(95%CI) 
60% 
5.5% 
11% 
[54.5%; 65.5%] 
70% 
5.2% 
10.4% 
[64.8%; 75.2%] 
80% 
4.5% 
9% 
[75.5%; 84.5%] 
90% 
3.4% 
6.8% 
[86.6 %; 93.4%] 
DATA STATISTICAL ANALYSIS 
Analysis populations: 
 
Eligible population: all the patients included without major 
deviation from the eligibility criteria. 
 
Eligible and assessable population: eligible patients having 
completed all 14 items on the FCCHL scale to calculate the overall 
health literacy score. 
 
Primary endpoint analysis: 
 
The primary end point analysis will cover the eligible, assessable 
population. 
 
The analyses will be conducted independently in each of the two 
populations A and B. 
 
The percentage of patients with a low level of health literacy will 
be calculated as follows:  
o Each item on the FCCHL takes a score of 1 to 5 points. 
o For each patient, a literacy score per sub-scale (functional, 
interactive and critical) will be determined by calculating the 

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number of points divided by the number of items on the sub-
scale. The score can range from 1 to 5. 
o An overall literacy score will be calculated for each patient, by 
determining the mean of the functional, interactive and critical 
literacy scores. The score can range from 1 to 5. 
o The percentage of patients with a low level of health literacy 
will be calculated for each population (A, B), by dividing the 
number of patients with an overall score of ≤ 4 by the number 
of eligible and assessable patients. The percentage will be 
reported along with its 95% confidence interval (binomial law). 
 
The responses to the FCCHL scale will be described for each 
population (A, B) by sub-scale and overall, by calculating the mean 
and the standard-deviation of the 4 literacy scores (functional, 
interactive, critical and overall) resulting for each patient.  
 
The quantitative variables will be described based on the mean and 
standard-deviation if the assumption of normality is followed, 
otherwise other descriptive statistics will be used (minimum, 
maximum, median and quartile). 
 
The qualitative variables will be described based on numbers and 
associated frequencies, given as a percentage (%). 
EXPECTED RESULTS 
For patients: 
Determining the level of health literacy of cancer patients, with a 
special focus on the elderly, would make it possible to provide 
information that is more compatible with the mean level of literacy in 
this population. Determining the level of digital health literacy in the 
same population would make it possible to find out whether digital 
follow-up is feasible. Appropriate education could be implemented to 
develop their ability to access, understand, appraise, and apply basic 
health information. 
For public health: 
Better understanding of health literacy would make it possible to 
improve and develop prevention actions for cancer patients and elderly 
patients in particular. This could lead to a decrease in healthcare costs, 
better treatment compliance, reduction in adverse effects and fewer 
hospitalisations, emergency department admissions and readmissions.