THERANOVA-LIM: Improving knowledge of oral therapies for patients and healthcare professionals

doi:10.21203/rs.3.rs-4968040/v1

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Research Article

THERANOVA-LIM: Improving knowledge of oral therapies for patients and healthcare professionals

https://doi.org/10.21203/rs.3.rs-4968040/v1

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Background

Recent developments in oral chemotherapy and targeted therapies have radically changed the way in which cancer patients are managed. Ambulatory care is now common, associated with the development of organizations that foster, secure home treatments, and reinforce the city hospital link.

Methods

THERANOVA-LIM (NCT04931329), a prospective study, assessed the satisfaction of healthcare professionals and patients who benefited from improved access to information on appropriate drug use imparted by a drug vigilance card or a prescription with a QR code connected to specific website. Patients had access to advice sheets associated with the molecules used in the therapy, and information sheet to help manage side-effects. Before setting up this programme, a practice assessment survey was carried out among healthcare professionals to understand their needs in terms of prescribing oral therapies.

Results

An e-questionnaire was used to explore the practices and expectations of retail pharmacists, Only 40% stated that they felt comfortable when managing patients on oral therapy which was the starting point for the study. A total of 128 patients were included in the study. Patients received one or other of the systems : 55 received “medication vigilance card” group and 73 a “prescription with QR code”. The median age was 69 years (range 37–90 years); 85 women and 43 men. The three most common cancers were breast (37.5%), prostate (14.1%), and brain (10.9%) cancers. The vast majority of patients had metastatic cancer (90%). The four most prescribed drugs were capecitabine (21.1%), ribociclib (11.7%), temozolomide (11.7%), and trifluridine/tipiracil (7.8%). The occasions on which patients presented cards included medical consultations (25.0%), visits to the pharmacy (100%), and when the homecare nurse was in attendance (25.0%).Patients were similarly satisfied with the new systems (p = 0.8) and as professionals. However, health professionals felt that the prescription with a QR code was of greater assistance than the drug vigilance card (p = 0.02).

Conclusion

Both systems help to improve access to knowledge about oral treatments. This encourages us to extend the innovations and evaluate them further.

Trial Registration Number and the date of registration

: ClinicalTrials.gov, NCT04931329. 2021-05-10

treatment

cancer

safety

website

prescription

QR codes

Recent developments in oral chemotherapy and targeted therapies have radically changed the management of cancer patients [1]. Intravenous drugs were traditionally administered in the hospital, but outpatient oral cancer treatments are now developing rapidly, encouraging patients, families, and medical teams to reconsider the hospital-centric model of care [2, 3]. The French National Cancer Institute (INCa) estimated that oral anticancer drugs would represent half of the therapeutic oncological arsenal [4]. Oral treatments offer several advantages that improve patient quality-of-life [5] and well-being [6] [7]. However, it is necessary to guarantee safe use [8]. The major risks include poor compliance, drug interactions, and toxicity [9]. Early detection of adverse effects can help avoid emergency hospitalization, non-adherence, or treatment discontinuation [10]. Healthcare organizations must be highly coordinated to ensure quality of care and patient safety as patients move between the city and the hospital [11]. Optimization of home care for cancer patients requires coordinated intervention by hospital and outpatient healthcare professionals who prevent, detect, and manage adverse events; avoid drug interactions; and counter drug misuse by educating patients, as advocated by the 2014–2019 Cancer Plan. Interdisciplinary coordination of various healthcare players is essential to ensure optimal care. In our centre, we are lucky enough to have an oral therapy centre with nurses who treat all patients with oral therapy. The operation of this centre has been published previously [12]. Preliminary work has highlighted the value of a drug vigilance card for improving information on knowledge of treatments for chronic lymphocytic leukaemia, chronic myeloid leukaemia and multiple myeloma[13].

THERANOVA-LIM (Innovative therapy in New Aquitaine and Limousin) project is to develop access to therapeutic advice sheets, open to patients, their carers and pharmacists involved in coordinating the complex healthcare pathway and the patient's care in the community: pharmacists, GPs, private nurses, etc. We present here a feasibility study to assess the satisfaction of healthcare professionals and patients who have benefited from a new method of accessing information on the correct use of oral treatments.

Study design

The THERANOVA-LIM study was a prospective, descriptive, non-interventional, single-center study. The first group of patients were given oral treatment information card or drug vigilance card (Fig. 1a) then the second group were given a medical prescription with a specific QRcode for oral treatment (Fig. 1b). Phase 1 (drug vigilance card) patients were enrolled from November 08, 2021, to April 07, 2022, and phase 2 (prescription) patients from June 01, 2022, to August 30, 2022.

Before setting up this programme, a practice assessment survey was carried out among healthcare professionals to understand their needs in terms of prescribing oral therapies. Eleven questions were asked, including 2 with free text.

The inclusion criteria were: treatment at the oral therapy center of the oncology department of Limoges University Hospital [14, 15]; at least one oral chemotherapy and/or targeted therapy; and the ability to speak and understand French. The exclusion criteria were: endocrine therapy alone (excluding the new-generation therapies [abiraterone and enzalutamide] used to treat prostate cancer); injectable therapy alone; and a lack of Internet access required to activate the card, and/or a cell phone.

How the drug vigilance card works

It was a rigid card in the format of a bank card (Fig. 1a). The front of the card contained: the name of the oral treatment, a QR code giving direct access to the patient's account on the platform, and the unique key and access code for creating the card. On the back of the card were written : The patient's surname, first name, date of birth and contact details for our centre. Scanning the QR code directs the patient to a dedicated online platform [16].

On this plateform there are 2 parts. In the first part, the patient can complete their identity and administrative details, health data, the list of healthcare professionals involved in their care. On the second part, patients had access to advice sheets associated with the molecules used in the therapy, and information sheet to help manage side-effects, drawn up by two oncologists from the Limoges department depending on the molecule used. Patients could access and control their data at any time. With or without help, they could modify the information on the card by adding files (prescriptions, test results, etc.) or deleting them. He was the sole owner of the content of his account. In addition, to protect access to the patient's personal data, authentication was required after scanning the QR code. This meant that carers and healthcare professionals needed to have the patient's consent to access the data on the card. The patients with the cards had standard prescriptions for oral therapies, i.e. without QRcodes.

How the QRcode works on prescriptions

Scanning the QR code on the prescriptions (Fig. 1b) directs the patient to our Association of Medical Oncology and Radiotherapy (AOMR) website [17]. Patients had access to advice sheets associated with the molecules used in the therapy, and information sheet to help manage side-effects, drawn up by two oncologists from the Limoges department depending on the molecule used. Unlike the drug vigilance card, anyone can access it without double authentication, but no personal data is available. The procedures for monitoring and issuing cards/new prescriptions are set out in Fig. 2.

Objectives and assessment criteria

The main objective was to measure patient satisfaction at 3 months (M3) with 12 questions adapted from the Computerized System Usability Questionnaire (CSUQ); all answers were scored on a 7-point Likert scale [18]. The questions were adapted from previous publications [13, 19]. The secondary objectives were to measure the satisfaction of healthcare professionals at M3 and to describe patients and treatment characteristics. A link to the e-questionnaire was sent via e-mail; the survey could be completed only once from that IP address. All questionnaire replies (online and paper) were anonymous.

Human Ethics and Consent to Participate

This research was carried out in compliance with the French law n°2012 − 300 of March 5, 2012 relating to research involving the human person and the Declaration of Helsinki (which can be found in its full version on the website http://www.wma.net/en/30publications/10policies/b3/).This research was approved by the Comité de Protection des Personnes (approval no. 2021-A01230-41). The study is registered with ClinicalTrials.gov, NCT04931329. All patients enrolled in the study provided written informed consent.

Statistical analysis

Given the lack of data on this subject and on this new-generation card, it was decided to include all eligible patients. All data were collected and analyzed using R software (version 4.1.1; R Foundation for Statistical Computing, Vienna, Austria). Quantitative variables are expressed as numbers, medians with minima, and maxima, or means with standard deviations. Qualitative variables are expressed as numbers with percentages. To study the relationships between different variables (via bivariate analysis), we used the Mann-Whitney test to compare the scores of the two groups. The chi-square test was employed to compare qualitative variables. All significance thresholds were set to 5%. All patients who consulted during the study period and who met the eligibility criteria and wished to participate were included.

Preliminary survey of pharmacists

Forty-six pharmacists replied to our questionnaire. Nearly 70% (n = 32) of the pharmacists questioned said that they were approached by patients when they experienced adverse effects related to their cancer treatment. But, only 40.0% ( n = 18) said they felt comfortable when managing a patient on oral therapy, 62.0% (n = 30) were aware of the usual advice sheets associated with the molecules used in the therapy for patients.

Of the 30 who knew theses advice sheets associated with the molecules, only half (n = 15) consulted them regularly and 58.0% (n = 19) printed them for patients when the drugs were first dispensed. Among all the pharmacist, only 20,0% (n = 9) said they were in regular contact with the oncology department. 69.6% (n = 32) were contacted by patients who experienced adverse events related to cancer treatment. Healthcare professionals lacked knowledge of and training on anticancer drugs, attributable to the rapid development of new agents and the complexity of the protocols. It was acknowledged that communication between independent professionals and hospital departments was suboptimal.

Clinicopathological characteristics of patients

The flow chart for the study is shown in Fig. 3. A total of 128 patients were included, 55 with the “drug vigilance card” and 73 with the “prescription with QR code” group (Fig. 3). The clinicopathological characteristics are presented in Table 1 and were comparable between the two groups. The median age at inclusion was 69 years (range 37–90 years); there were 85 women and 43 men. The majority of patients lived as couples (89.1%), were retired (74.8%), and resided in the University Hospital Center area (64.6%). The three most common cancers were breast (37.5%), prostate (14.1%), and brain (10.9%) cancers. The vast majority of patients had metastatic cancer (90%).

Table 1

Clinicopathological characteristics of patients
	Whole population	Phase 1 (drug vigilance card)	phase 2 (prescription)	p-values
Total, n (%)	128 (100)	55 (43)	73 (57)
Median age at inclusion, years (min-max)	69 (37–91)	69 (37–91)	70 (38–89)	0.1852
Female/ Male	85 (66.4) / 43 (33.6)	39 (70.9) / 16 (29.1)	46 (63.0) / 27 (37.0)	0.4549
Performans status at baseline n (%)
0	37 (28.9)	14 (25.5)	23 (31.5)	0.4764
1	75 (58.6)	36 (65.5)	39 (53.4)
2	15 (11.7)	5 (9.0)	10 (13.7)
3	1 (0.8)	0	1 (1.4)
Lifestyle*
Single/ In couple	20 (15.9) / 106 (84.1)	6 (10.9) / 49 (89.1)	14 (19.7) / 57 (80.3)	0.2927
Apartment/ house/ other lodging	14 (11.1) / 110 (87.3) / 2 (1.6)	5 (9.1) / 50 (90.9) / 0	9 (12.7) /60 (84.5) / 2 (2.8)	0.3091
Lives in the University Hospital Center area Yes/No	82 (64.6) / 46 (35.4)	35 (63.6) / 20 (36.4)	47 (64.4) / 33 (35.6)	1
Retired/ In work/ On disability	95 (74.8) / 27 (21.3) / 5 (3.9)	40 (74.1) / 14 (25.9) / 0	55 (75.3) / 13 (17.8) / 5 (6.8)	0.112
Cancer n (%)
Cardia	1 (0.8)	0	1 (1.4)	0.4232
Colon	10 (7.8)	7 (12.7)	3 (4.1)
Endometrium	1 (0.8)	0	1 (1.4)
Ovary	12 (9.4)	5 (9.1)	7 (9.6)
Pancreas	3 (2.3)	2 (3.6)	1 (1.4)
Prostate	18 (14.1)	5 (9.1)	13 (17.8)
Rectum	3 (2.3)	1 (1.8)	2 (2.7)
Kidney	12 (9.4)	6 (10.9)	6 (8.2)
Breast	48 (37.5)	21 (38.2)	27 (37.0)
Brain tumors	14 (10.9)	7 (12.7)	7 (9.6)
Adrenal	2 (1.6)	0	2 (2.7)
Biliary tract	4 (3.1)	1 (1.8)	3 (4.1)
Stage at inclusion of gliomas (n = 14)
Grade III	2 (15)	1 (14)	1 (14)	0.8534
Grade IV	12 (85)	6 (86)	6 (86)	0.8534
Stage at inclusion excluding gliomas (n = 114)
Stage I-III	11 (10)	2 (4)	9 (14)	0.0018
Stage IV	103 (90)	46 (96)	57 (86)	0.0018
Metastatic from the outset
No	86 (67.2)	33 (60.0)	53 (72.6)	0.1891
Yes	42 (32.8)	22 (40.0)	20 (27.4)	0.1891
Situation at baseline
Adjuvant setting	25 (19.5)	9 (16.4)	16 (21.9)	0.5758
Metastatic setting	103 (80.5)	46 (83.6)	57 (78.1)	0.5758
* Missing data

Treatments characteristics and Treatment management.

The treatments received by the patients are shown in Table 2. The four most prescribed drugs were capecitabine (21.1%), ribociclib (11.7%), temozolomide (11.7%), and trifluridine/tipiracil (7.8%). In 43.0% of cases, it was necessary to modify the drug dose during the management. During the phase 1, 83.6% attended hospital pharmaceutical appointments and in phase 2, 28.8% (p < 0.001). The numbers of telephone calls made by the oral therapy center were identical for both groups. During the study, 25.0% of patients experienced grade III or IV toxicities that were reported to pharmacovigilance; 6 (4.7%) were admitted to the emergency department, 11 (8.6%) were hospitalized, and 10 (11.1%) had to permanently cease treatment. No toxic deaths occurred.

Table 2

Treatment received by the patients
	Whole population	Phase 1 (drug vigilance card)		Phase 2 (prescription)			p-values
Total, n (%)	128 (100)	55 (43)		73 (57)
Oral therapy, n (%)
Abemaciclib	5 (3.9)	2 (3.6)		3 (4.1)			0.06865
Abiraterone	9 (7.0)	4 (7.3)		5 (6.8)
Axitinib	6 (4.7)	3 (5.3)		3 (4.1)
Cabozantinib	4 (3.1)	2 (3.6)		2 (2.7)
Capecitabine	27 (21.1)	9 (16.4)		18 (24.7)
Enzalutamide	9 (7.0)	1 (1.8)		8 (11.0)
Everolimus	2 (1.6)	2 (3.6)		0
Lenvatinib	1 (0.8)	0		1 (1.4)
Niraparib	9 (7.0)	5 (9.1)		4 (5.5)
Olaparib	4 (3.1)	1 (1.8)		3 (4.1)
Palbociclib	5 (3.9)	1 (1.8)		4 (5.5)
Pazopanib	1 (0.8)	0		1 (1.4)
Regorafenib	1 (0.8)	1 (1.8)		0
Ribociclib	15 (11.7)	9 (16.4)		6 (8.2)
Sorafenib	1 (0.8)	0		1 (1.4)
Sutinib	2 (1.6)	1 (1.8)		1 (1.4)
Temozolomide	15 (11.7)	7 (12.7)		8 (11.0)
Trifluridine/tipiracil	10 (7.8)	6 (10.9)		4 (5.5)
Vinorelbine	2 (1.6)	1 (1.8)		1 (1.4)
Prescription procedures, n (%)
Early access	2 (1.6)	0		2 (2.7)			0.4113
Clinical trial	2 (1.6)	1 (1.9)		1 (1.4)
Routine pratice	124 (96.9	54 (98.1)		70 (95.9)
Adjusting the dose of prescribed treatment, n (%)
No	73 (57.0)	29 (52.7)		44 (60.3)			0.5006
Yes	55 (43.0)	26 (47.3)		29 (39.7)			0.5006
Pharmaceutical consultation, n (%)
No	61 (47.7)	9 (16.4)		52 (71.2)			< 0.001
Yes	67 (52.3)	46 (83.6)		21 (28.8)			< 0.001
Number of center calls, median (min-max)	6 (0–20)	7 (0–15)		6 (1–20)			0.4868
Toxicity III-IV reported to pharmacovigilance, n (%)
No	96 (75.0)		39 (70.9)		57 (78.1)	0.4627
Yes	32 (25.0)		16 (29.1)		16 (21.9)	0.4627
Emergency room visits for toxicity, n (%)
No	122 (95.3)		52 (94.5)		70 (95.9)	1
Yes	6 (4.7)		3 (5.5)		3 (4.1)	1
Hospitalization for toxicity, n (%)
No	117 (91.4)		49 (89.1)		68 (93.2)	0.6222
Yes	11 (8.6)		6 (10.9)		5 (6.8)	0.6222
Permanent discontinuation of treatment due to toxicity, n (%)
No	80 (88.9)		40 (88.9)		40 (88.9)	0.0816
Yes	10 (11.1)		5 (11.1)		5 (11.1)	0.0816

Assessing patient satisfaction

Of the 128 included patients, 119 patients who could be evaluated (9 died during the study: 7 during phase 1 and 2 during phase 2) and the questionnaire response rates were 37.0% (n = 44) : 25.0% (n = 12/48) for phase 1 and 45.0% (n = 32/71) for the phase 2.

The principal results are shown in Table 3. Patients in both groups were generally satisfied with the system and the ease of use of both the card and the prescription (p = 0.9). The occasions on which patients presented cards included medical consultations (25.0%), visits to the pharmacy (100%), and when the homecare nurse was in attendance (25.0%).

Table 3

Patient satisfaction at 3 months.
	Whole population		Phase 1 (drug vigilance card)		Phase 2 (prescription)		p-value
Total, n (%)	44 (100)		12 (27)		32 (72)
1. In general, I'm satisfied with this system (n = 37)
median (min-max)	7 (2–7)		6 (5–7)		7 (2–7)		.8970
2. In general, I'm satisfied with the ease of use of this system (n = 36)
median (min-max)	7 (2–7)		6 (4–7)		7 (2–7)		.4603
3. This system is easy to use (n = 36)
median (min-max)	7 (2–7)		7 (3–7)		7 (2–7)		.3922
4. I feel comfortable with this system (n = 37)
median (min-max)	6 (1–7)		6 (4–7)		7 (1–7)		.6732
5. It was easy to understand how to use this system (n = 37)
median (min-max)	6 (1–7)		6 (3–7)		7 (1–7)		.6265
6. When I made a mistake, it was quick and easy to correct it (n = 34)
median (min-max)	6 (4–7)		6 (4–7)		NA
7. I easily found the information I was looking for (n = 35)
median (min-max)	6 (2–7)		6 (5–7)		7 (2–7)		.8348
8. The system's information is easy to understand (n = 35)
median (min-max)	7 (2–7)		6 (5–7)		7 (2–7)		.9308
9. System screens are clearly organized (n = 35)
median (min-max)	6 (4–7)		6 (4–7)		NA
10. L’interface de ce système est agréable (n = 35)
median (min-max)	6 (4–7)		6 (4–7)		NA
11. I like using the interface of this system (n = 35)
median (min-max)	6 (4–7)		6 (4–7)		NA
12. This system has all the functions and potential I was looking for (n = 35)
median (min-max)	7 (1–7)		6 (4–7)		7 (1–7)		.8621
13. Did you show your card/prescription?
No	9	20.5%	5	41.7%	4	12.5%	.0661
Yes	35	79.5%	7	58.3%	28	87.5%	.0661
14. If yes, have you shown it to your doctor? (n = 32)
No	21	65.6%	5	71.4%	16	64%	.3988
Yes	11	34.4%	2	28.6%	9	36%	.3988
If so, have you shown it to your pharmacist? (n = 33)
No	3	9.1%	0	0%	3	11.5%	.2026
Yes	30	90.9%	7	100%	23	88.5%	.2026
If so, did you show it to your nurse? (n = 34)
No	24	70.6%	5	71.4%	19	70.4%	.1852
Yes	10	29.4%	2	28.6%	8	29.6%	.1852
If yes, I have shown it during hospitalization (n = 35)
No	33	94.3%	8	100%	25	92.6%	.3262
Yes	2	5.7%	0	0%	2	7.4%	.3262
If yes, I've shown it in emergency situations (n = 35)
No	34	97.1%	8	100%	26	96.3%	.3766
Yes	1	2.9%	0	0%	1	3.7%	.3766
If yes, I showed it during a consultation (n = 35)
No	24	68.6%	6	75%	18	66.7%	.3948
Yes	11	31.4%	2	25%	9	33.3%	.3948
If so, I showed it to the pharmacy: (n = 35)
No	5	14.3%	0	0%	5	18.5%	.2
Yes	30	85.7%	8	100%	22	81.5%	.2
If yes, did I show it to my nurse? (n = 35)
No	25	71.4%	6	75%	19	70.4%	.419
Yes	10	28.6%	2	25%	8	29.6%	.419
15. Has this prescription/card helped you remember to take your medication? (n = 31)
median (min-max)	5 (1–10)		5 (1–10)		5 (1–10)		.2826
16. Has the presence of a QR code on this card/ prescription been useful? (n = 31)
median (min-max)	7 (1–10)		7 (1–10)		5 (1–10)		.8635
NA : not applicable
Questionnaire based on a 7-point Likert scale ranging from disagreement (0) to total agreement (7) and 10 points (*).

The satisfaction of healthcare professionals

A total of 74 evaluations were collected (Table 4). Healthcare professionals were equally satisfied with the two QR code systems (100% vs. 91.7%). The QR code affixed to the prescription was, however, easier to access (64.3% vs. 91.7%, p = 0.02).

Table 4

The satisfaction of healthcare professionals at 3 months.
	Whole population	Phase 1 (drug vigilance card)	Phase 2 (prescription)	p-value
Total, n (%)	74 (100)	14 (18.9)	60 (81)
Did you know that your patient has a drug card / prescription with QR code?
No	13 (17.6)	0	13 (21.7)	.1274
Yes	61 (82.4)	14 (100)	47 (78.3)	.1274
Has your patient shown you his drug card/prescription with QR code?
No	31 (41.9)	9 (64.3)	22 (36.6)	.1129
Yes	43 (58.1)	5 (35.7)	38 (63.3)	.1129
Did the card or QR code prescription have an impact on this patient's care?
No	26 (35.1)	3 (21.4)	23 (38.3)	.3777
Yes	48 (64.9)	11 (78.6)	37 (61.7)	.3777
If yes. has it had an impact on treatment information and management?
No	11 (23.9)	5 (45.5)	6 (17.1)	.1298
Yes	35 (76.1)	6 (54.5)	29 (82.0)	.1298
If yes. has it had an impact on the risks associated with this treatment? *
No	6 (13)	2 (18.2)	4 (11.4)	.9466
Yes	40 (87)	9 (81.8)	31 (88.6)	.9466
If yes. did it have an impact on information on how to proceed with this treatment? *
No	10 (21.7)	4 (36.4)	6 (17.1)	.3528
Yes	36 (78.3)	7 (63.6)	29 (82.9)	.3528
In general. I'm satisfied with this system
No	5 (6.8)	0	5 (8.3)	.5980
Yes	69 (93.2)	14 (100)	55 (91.7)	.5980
In general. I'm satisfied with the ease of use of this system
No	10 (13.5)	5 (35.7)	5 (8.3)	.0246
Yes	64 (86.5)	9 (64.3)	55 (91.7)	.0246
* 2 missing data

The aim of the project was to develop access to therapeutic advice sheets for patients, their carers and pharmacists involved in coordinating complex healthcare pathways and patient care in the community. In this study, we showed that patients and healthcare professionals were generally satisfied with this method of communicating information about oral therapies. The THERANOVA-LIM project aims not only to improve coordination between the various healthcare players, but above all to transform the experience of oncology patients. The innovative approaches implemented in this project will bring numerous benefits for cancer patients, by optimising their treatment and improving their quality of life.

First, QR codes integrated into prescriptions and medication cards give patients direct access to detailed and constantly updated therapeutic advice sheets. Patients no longer have to worry about losing paper documents or searching for information. By simply scanning the QR code with their smartphone, they have immediate access to essential, up-to-date information about their treatments.

Then, therapeutic advice leaflets provide specific information relating to medicines, including side effects, precautions to take, possible interactions with other medicines, and nutritional advice. Patients receive relevant, personalised information. They help them to understand their treatment and follow medical recommendations more rigorously, contributing to patient empowerment and ongoing education for patients and carers to feel more in control of their situation, reducing anxiety and increasing confidence in the treatment being followed.

Among professionals practising outside the hospital, we gave priority to pharmacists. In French, pharmacy is the place where health professionals are available without appointment; pharmacists must have timely and detailed information to ensure optimal care. Pharmacies are widespread and play key roles in care, particularly when patients require security and support.

Communication among healthcare professionals is vital [20]; presently, no optimal support system is today available [21]. Occhipinti et al. showed that, although 44.4% of institutions had established communication between city and hospital, all found that this was time-consuming [22].

Digitization in cases of complex care required by patients with chronic illnesses, particularly cancer, is essential [23]. Initiatives to improve the sharing of information between hospital and outpatient professionals have already been underway for a number of diseases, including diabetes. The Dijon and Besançon university hospitals have created “identity cards” for diabetics [24] that feature a QR code indicating the required treatment, particularly in the event of an emergency [25]. The QR code system has been but little used by oncologists who require access to medical data or specific patient information. [26, 27].

The coded QR card may seem interesting, particularly in terms of its format, because patients can carry coded QR cards at all times, but this does not mean that they are autonomous. Both the digital divide and difficulties in accessing technology are still in play. Even the average age of our population is similar to that nationally [28], the impact of age and access to new technologies must be particularly taken into account. Some studies on remote monitoring, particularly of oral therapy, included much younger patients [29, 30]. For example, in the Capri study, the median age was 62 years (range 20–92 years); 27.7% of patients were aged between 65 and 74 years and 14% over 75 years [29]. The proportions of patients who use new technologies, particularly smartphone applications, are often age-dependent [29, 31, 32]. On the contrary, prescriptions are easy to use at any age. A limitation of the QR code system for prescription is that it applies only to drugs dispensed in hospitals, not community pharmacies, the staff of which thus lack knowledge of cancer treatments such as temozolomide.

Website and smartphone applications aid symptom management. In a review, Penedo et al. found that e-Health technologies aided cancer treatment [33]. However, if such systems are exclusively patient-centric, they will not be accessible by healthcare professionals. We cannot assess whether the use of QR codes reduced the incidence and impact of toxicity; the study was not designed to answer this question. However, the toxicity rate of 25.0% is in line with the literature [29] and the number of toxicity management calls was lower than in our previous publication [14].

The monocentric nature of the present study is one limitation, particularly in terms of representativeness. The fact that the study was performed in two successive phases reflects technical imperatives; it was necessary both to create cards and develop software that placed QR codes on prescription. Moreover, self-questionnaires may introduce information bias. Some patients chose not to answer certain questions. In addition, a Hawthorne effect may be in play; patients who are aware that they are being surveyed may (consciously or unconsciously) overestimate their compliance rates [34]. Recruitment bias may be in play; many patients had brain tumors (our center has expertise in this field) [14, 35]. However, unlike other studies, we did not select particular types of tumors and the QR code was available to all cancer patients. Setting up the cards is a complex and time-consuming task for the professional in charge, since the tool requires several stages: 1/attaching a card to each patient, 2/creating the account, 3/explanation and demonstration time for the patient, 4/contacting healthcare professionals and explanation time. This model also presents difficulties of reproducibility over time, since it requires a dedicated person to carry out the tasks mentioned above. For this reason, Prescriptions seems to be the easiest to use. This makes the format more attractive, particularly in terms of its ease of implementation and use. One of the limitations of the one of the limitations of the QR code system is that prescriptions for hospital-issued drugs are not provided to community pharmacies, which have no knowledge of anti-cancer treatments such as temozolomide.

We evaluated two systems with integrated QR codes (with prescription or cards) which provide access to information on the correct and safe use of drugs. The positive feedback and feasibility of this system encouraged us to develop a website that provides QR codes with free access for all prescribers who wish to insert QR codes on patients' prescriptions (https://www.youtube.com/watch?v=xz74pljCtLY). The patient or those close to him will be able to “flash” with a smartphone all the QR codes, integrated into the prescription, and thus view the medication advice sheet. The system will be evaluated further by healthcare professionals. The increased availability of most oral anticancer drugs outside hospitals requires greater collaboration between hospital and primary care professionals, particularly dispensing pharmacists. It is essential to improve the continuity of care.

AOMR

Association of Medical Oncology and Radiotherapy

CSUQ

Computerized System Usability Questionnaire

INCa

French National Cancer Institute

at 3 months

THERANOVA-LIM

Innovative therapy in New Aquitaine and Limousin

Conflict of Interest

The authors declare that they have no conflict of interest in relation to this study.

Consent for publication
The authors give consent to publication.

Author Contribution

Conceptualization, E.D.; methodology, E.D., SL. ; formal analysis, S.L. ; writing - original draft preparation, M.B., E.D., S.L. ; writing - review and editing, M.B., S.L., K-A.B., T.D., C.P., V.L.-B., J.P., L.V., F.T.S.H., J.J., M.T., E.D.; supervision, E.D. All the authors have read and agreed to the published version of the manuscript.

Acknowledgement

This work was funded by the Ligue Contre le Cancer, ALAIR, Accord Pharmafield, AstraZeneca, Janssen, Seagen, Crédit Mutuel Loire-Atlantique, and the ERRE family.

Data availability

Data are available from the corresponding author upon reasonable request

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No competing interests reported.

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THERANOVA-LIM: Improving knowledge of oral therapies for patients and healthcare professionals

Status:

Version 1

Abstract

Background

Methods

Results

Conclusion

Trial Registration Number and the date of registration

Figures

INTRODUCTION

MATERIALS AND METHODS

Study design

How the drug vigilance card works

How the QRcode works on prescriptions

Objectives and assessment criteria

Human Ethics and Consent to Participate

Statistical analysis

RESULTS

Preliminary survey of pharmacists

Clinicopathological characteristics of patients

Assessing patient satisfaction

The satisfaction of healthcare professionals

DISCUSSION

CONCLUSION

Abbreviations

Declarations

Conflict of Interest

Consent for publication
The authors give consent to publication.

Author Contribution

Acknowledgement

Data availability

References

Additional Declarations

Status:

Version 1

THERANOVA-LIM: Improving knowledge of oral therapies for patients and healthcare professionals

Status:

Version 1

Abstract

Background

Methods

Results

Conclusion

Trial Registration Number and the date of registration

Figures

INTRODUCTION

MATERIALS AND METHODS

Study design

How the drug vigilance card works

How the QRcode works on prescriptions

Objectives and assessment criteria

Human Ethics and Consent to Participate

Statistical analysis

RESULTS

Preliminary survey of pharmacists

Clinicopathological characteristics of patients

Assessing patient satisfaction

The satisfaction of healthcare professionals

DISCUSSION

CONCLUSION

Abbreviations

Declarations

Conflict of Interest

Consent for publication The authors give consent to publication.

Author Contribution

Acknowledgement

Data availability

References

Additional Declarations

Status:

Version 1

Consent for publication
The authors give consent to publication.