Abstract
Background
In Italy medical cannabis is a prescription drug since 1998. Even though it could not be considered a therapy as such, it is indicated as a symptomatic treatment also in cancer patients, to cure iatrogenic nausea/vomiting and chronic pain.
Patients and methods
We conducted a knowledge survey about medical cannabis among cancer patients referred to two outpatient cancer care centers and a home care service.
Results
From February to April 2018, 232 patient were enrolled; 210 patients were on active disease-oriented treatment (90.5%), while 22 (9.5%) not. Eighty-one percent of the patients have heard about medical cannabis, but only 2% from healthcare professionals. Thirty-four percent of responders thought about using cannabis to treat one or more of their own health problems, especially pain (55%). Despite that, 18% of the participants believe that medical cannabis could have negative effects on their own symptoms. Patients with high educational level better knew cannabis (odds ratio = 3.52; 95% confidence interval: 1.07–11.53), and medical cannabis (odds ratio = 3.21; 95% confidence interval: 1.48–6.98), when compared to patient with low educational level. Patients who were on active disease-oriented treatment better knew medical cannabis (odds ratio = 3.91; 95% confidence interval: 1.26–12.11) compared to “out of treatment” patients. Metastatic patients were less informed about medical cannabis compared to patients on adjuvant treatment.
Conclusions
Our survey shows that most of Italian cancer patients know medical cannabis and a third of them have considered using cannabis to treat one (or more) of their own health problems. In the same time, they are poorly informed and do not tend to ask for information about medical cannabis to healthcare professionals.
Introduction
In Italy cannabinoid-based medicines are prescription drugs since 1998 1 ; in September 2014 the official Italian production of the cannabis FM2 began. 2 FM2 contains from 5 to 8% of tetrahydrocannabinol and from 7.5 to 12% of cannabidiol (CBD). To date, any qualified and registered physician can prescribe drugs with cannabis FM2 in Italy, even if the arrangements of reimbursement of its cost widely vary among the different local administrations. 3 Within the Ministry of Health's circular letter containing the recommendations for the prescription of FM2-based drugs, it is clearly stated that medical cannabis (MC) could not be considered a therapy as such, but a symptomatic treatment, which should be used when standard treatments failed or are no longer tolerated. 3 Also the indications of MC are mentioned within the same document: chronic condition associated with spasticity (multiple sclerosis, spinal cord lesions), chronic pain (including cancer pain) in case of failure of standard analgesic therapy, iatrogenic nausea/vomiting, anorexia, glaucoma, and Tourette's syndrome (to reduce involuntary movements). 3
A multicenter Australian survey conducted among 204 advanced cancer patients revealed that 13% of them reported prior MC use. 4 Recently, a Canadian group conducted a survey among 3138 cancer patients; 17.9% of the respondents reported using cannabis within the previous six months (which could be interpreted as a medical use), and 36% of them were new users. 5
Against the lack of data about the “prescription penetrance” of MC in cancer patients, we conducted knowledge survey about MC among Italian cancer patients.
Methods
Study design
This is a cross-sectional study conducted among cancer patients in both a “simultaneous care” and a “supportive care” setting. Patients were enrolled at Medical Oncology of St Salvatore University Hospital in L'Aquila, at Simultaneous Care Unit of St Andrea University Hospital in Rome and by the home care service of the Tuscany Tumors Association in Florence. Data were collected using two anonymous self-administered questionnaires. The first questionnaire was the Italian version of the “Medical Cannabis Questionnaire” (MCQ), which had been developed for this study and contains 16 questions concerning the knowledge and the attitudes of the participants about the therapeutic use of cannabis (Supplementary file 1). The second was the Italian version of the Edmonton symptom assessment scale (ESAS). 6 Eligibility criteria were the proven cancer diagnosis and age ≥ 18 years. Anamnestic data regarding primary tumor, disease-oriented treatment, and therapeutic setting (adjuvant or metastatic) were also collected. Study participation was voluntary, and subjects were enrolled after a complete presentation of the research and providing written informed consent. The procedures followed were in accordance with the precepts of Good Clinical Practice and the declaration of Helsinki. The study was conducted following the rules of the local bioethical committee competent on human experimentation.
Statistical analysis
Descriptive statistics (frequencies for categorical variables) were calculated for 11 out of 16 items of MCQ, which were considered the most informative. Chi-square or Fisher's exact test was used to examine differences between categorical variables. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using a logistic model to estimate the independent associations of socio-demographic and clinical factors with cannabis knowledge and attitudes. Three logistic models with cannabis knowledge (yes/no), MC knowledge (yes/no), and MC use (yes/no) as dependent variables were computed. Independent variables were defined as follows: age ( ≤ 50; 51–70; > 70 years old), gender (female versus male), schooling (primary and middle school as low educational level/high school and university as high educational level), therapeutic setting (adjuvant versus metastatic), active disease-oriented treatment (yes versus no), and referral centers (outpatient cancer care centers versus home care service). Given to the therapeutic implications that MC use could have on chronic pain, we also used the score reported at the “pain item” of the ESAS scale as a continuous independent variable of the logistic model. The statistical analyses were performed using STATA statistical software version 14.2 (Stata Statistical Software, College Station, TX: StataCorp LP).
Results
Patients' characteristics.
ESAS: Edmonton symptom assessment scale.
Descriptive analysis of the answers to the medical cannabis questionnaire.
Multivariate analysis with logistic regression and adjusted odds ratios (OR). Relationships between cannabis knowledge/MC knowledge/MC use and socio-demographic features, therapeutic setting, and pain item of the ESAS scale.
CI: confidence interval; ESAS: Edmonton symptom assessment scale; OR: odds ratio. Note. Bold refer to statistically significant p values.
Discussion
Our survey reveals that most of cancer patients know what cannabis is and that it could be used for a medical purpose. Impressively, a third of them have considered using cannabis to treat one or more of their own health problems, in particular pain. Despite that, patients seem not having clear ideas about the possible positive or negative effects of MC, on the other hand, they seem not having interest in obtaining more information about it, by asking to healthcare professionals for instance.
We can say that our patients have a kind of “favorable predisposition” about MC use, but this predisposition seems not to be aligned to a real interest, because most of them does not even ask for information to healthcare professionals. A similar trend was reported by a study conducted among healthy population in Serbia, where MC use has not been legalized yet: the majority of study respondents expressed positive attitude toward legalization of MC. 7 Interestingly, in that study it was found that having relatives suffering from a health condition, which might be treated with MC, is associated with stronger positive attitudes toward MC legalization. 7
In our study, only three patients reported using MC, while analogous studies reported much higher MC use among cancer patients.4,5
In other countries the use of MC is so widespread that one wonders about patients satisfaction 8 and different perceived effects with Cannabis indica-based medicaments or Cannabis sativa-based medicaments. 9
A recent Australian study found that more than 60% of general practitioners reported one or more patients' enquiries of MC within the previous three months, and that the majority of them were supportive or neutral with regards to MC prescriptions. 10
It is not surprising that patients with higher educational level better knew MC, nor that patients on disease-oriented treatment or during adjuvant treatment are more likely to be informed about MC. In our opinion these tendencies could be related to the probability of being younger and more actively informed. Interestingly, home care patients better knew cannabis and MC (without significance), in spite of the fact that local legislations are more permissive for MC use in Abruzzo and Lazio rather than in Tuscany (the regions of L'Aquila, Rome, and Florence, respectively).11,12,13
A recent position paper of the Italian Group for Evidence Based Medicine (GIMBE) clearly states that the evidences supporting MC use in chronic cancer pain are weak, because of the few studies conducted and their methodological limitations. 14 Even looking to more recent data the evidences are quite scanty, despite the apparently good results15,16; a recent retrospective study has even investigated the possible interactions between cannabis and immunotherapy with nivolumab in NSCLC patients, without conclusive results. 17
As abovementioned, we developed this study to investigate the “prescription penetrance” of MC in cancer patients. Our first concern is that without consolidated data to reference on, cancer care professionals might take discordant positions about MC prescription, affecting patients' perceptions. It must be expected that patients and families might start to consider MC when all the established (conventional) treatments have failed, driven by desperation. As a recent article in the BMJ says, desperation may lead to underestimate the risks and overestimate the expected benefit, causing problems for both patients and healthcare systems. 18 In the next future, the challenge will be to correctly estimate the potential benefit of MC in cancer patients, in order to reach the proper benefit/risks profile. Unfortunately, “oncological” indications of MC mainly are supportive treatments, pain particularly. In this setting, patients characteristics (comorbidities, symptoms burden, concomitant treatments, and drug interactions) and the clinical outcomes (pain and nausea), which are difficult to measure, tend to bias clinical trial's results. First of all, clinicians must be trained to the proper MC use, knowing in the same time its therapeutic limits. Only with well-trained and aware professionals the right patient will have access to the right drug, avoiding self-prescriptions, and unpleasant overestimations/underestimations.
Among limits of this study we must recognize the small sample size and that the MCQ was not previously validated in a dedicated investigation. Despite that, this is the first Italian survey conducted among cancer patients on the topic.
Conclusion
To the best of our knowledge, this is the first Italian survey conducted among cancer patients on the topic. Most of the cancer patients seem to know what is MC and a third of them have considered using MC to treat one (or more) of their own health problems. In the same time, they are poorly informed and do not tend to ask for information about MC to healthcare professionals.
Supplemental Material
Supplemental material for What cancer patients actually know regarding medical cannabis? A cross-sectional survey with a critical analysis of the current attitudes
Supplemental Material for What cancer patients actually know regarding medical cannabis? A cross-sectional survey with a critical analysis of the current attitudes by Alessio Cortellini, Giampiero Porzio, Vincenza Cofini, Stefano Necozione, Raffaele Giusti, Paolo Marchetti, Maria A Aloe Spiriti, Andrea Costanzi, Flaminia Peris, Giulio Ravoni, Giuseppe Spinelli, Corrado Ficorella and Lucilla Verna in Journal of Oncology Pharmacy Practice
Footnotes
Acknowledgements
Authors would like to acknowledge Dr Martina Bruni, for the help in carrying out the project.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
Supplemental material
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References
Supplementary Material
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