Keywords:
Clinical trial - Patient advocacy - Awareness - Physician-Patient relations - Health
surveys.
Descritores:
Ensaio clínico - Defesa do paciente - Conscientização - Relações médico-paciente -
Pesquisas de saúde.
INTRODUCTION
Cancer treatment clinical trials are essential for developing new therapies and ensuring
they become available to all patients in need. When participating in a clinical trial
(CT), a patient plays an important and active role in this development, where he/she
can have access to potentially helpful treatments before they are available to the
general public, being also able to help other people by improving cancer care.
Patients' decisions regarding participating or not in a CT may be influenced by the
information they receive. Worries related to placebo use, decrease in quality of life
and lack of awareness on CT by the general population are among the main barriers
to CT recruitment.[1]
[2]
[3] Despite these concerns, 40% of patients would still accept to participate in a CT.[4] On the other hand, previous studies have shown that patients can have misconceptions
about aspects of research, such as the risk of adverse events, the trial's aims and
the likelihood of personal benefit.[5]
[6] This may lead to the low participation in CT: approximately 3% of adult cancer patients
participate in clinical trials in the US.[7] This indicates a clear gap between willingness to participate and effective participation
in CTs.
Understanding the main barriers to patient's recruitment is essential to improve enrollment
strategies and health access through CT, especially in severe diseases, as cancer.
A better understanding of patients' motivations for participating in cancer research
and their opinions of CT information and the consent process may lead to changes that
facilitate trial recruitment and improve patient satisfaction with the recruitment
process. Patient groups have an important role in patient's awareness, including adverse
events and treatment options - and this comprises CTs. Thus, they are an essential
tool to help in the recruitment of patients to CTs.
In Brazil, lack of information on clinical research may impair participation in CT.
Therefore, this study aims to identify the main barriers to CT participation, source
of information regarding CT, and evaluate CT awareness levels in followers of the
webpage of Oncoguia Institute, a Brazilian independent non-profit institution, with
the mission of helping cancer patients to live better. By identifying gaps and barriers
in of oncology patient advocacy group participants' knowledge, Oncoguia can plan strategies
and online actions aiming patient education improvement.
METHODS
Study design
This was an internet-based survey related to knowledge related clinical research from
Oncoguia Institute was available on the Institute's website, available online from
April 2012 until October 2014. The primary objective of the study was to identify
the level of knowledge on CT in Oncoguia's website users. The study population was
defined as all people with internet access that follow Oncoguia's webpage (15 million
accesses/year) or Facebook page (more than 220,000 followers).
This study was conducted according to the Brazilian regulation on anonymized surveys
(Resolution number 510 of 2016), which absolves surveys of personal opinion with anonymized
participants of approval in Institutional Ethics Committees. Also, the survey page
asked the participant if they consent to participate in the research. We did not collect
any identification of the respondents; so, collected data were fully anonymized in
order to ensure respondents confidentiality and privacy.
Questionnaire
In order to achieve the objectives of the study, we developed an online survey questionnaire
of easy comprehension in Brazilian Portuguese, separated in CT definition for the
respondent; sources of knowledge regarding CT; CT's role in advances of cancer treatment;
wiliness to participate in a CT; and, knowledge on any CT participation of any known
person. The full questionnaire is available in Brazilian Portuguese and translated
into English in Appendix 1.
Data analysis
This is a descriptive study with the aim of describe the population characteristics
and generate hypothesis. Survey responses were extracted, with counting/ranking for
those related to multiple-choice and categorization for those related to open-answer
questions. Subsequently, all outcomes were be summarized. In the description of data
defined as categorical variables were described by simple and cross contingency tabulation,
with absolute frequencies and percentages. All results are reported as the rate of
respondents with multiple choices for several questions.
RESULTS
From April 2012 until October 2014, 254 respondents answered the survey. In respondents'
opinion, clinical research was defined as “research to improve cancer treatment” (47.1%),
“clinical investigation” (22.0%), and “cure” (15.9%), while 13.6% did not know the
definition of clinical research, 1.0% claimed lack of information, and 0.3% gave inconclusive
answers.
The massive majority of respondents (69%) had internet as source of information regarding
clinical research, followed by newspapers and magazines (8%), physician's orientation
(8%), hospital informative material (7%), other healthcare professionals (3%), TV
or radio (2%), other patients (2%), and informative leaflets (1%). Almost all respondents
(99.6%) believe that clinical research can contribute to advances in cancer treatment,
and the reasons for that were: increasing the scientific knowledge (53.4%); improvement
in quality of life (53%); seeking the cure (48.2%); improvement of the treatment (42.9%);
and, finding novel treatment options (42.9%).
Regarding participation in CTs, 85% of the respondents would accept to participate.
The main reasons for accepting to participate or not are described in[Table 1]
. Among the respondents, only 20.1% knew someone who participated in a CT, of which
in 44.2% (n = 18) of the cases the respondent himself has already participated in
a clinical trial.
DISCUSSION
Clinical trials are a crucial step in advancing new treatments for the cancer care.
Thus, a thorough understanding of patient recruitment patterns and barriers to CT
is of paramount importance.[8]
Also, it is imperative to observe that patients can access the latest advancements
in cancer treatment through CTs. This is especially relevant in low- and middle-income
countries, where the burden of cancer care is increased, and new technologies are
not available or not affordable. Thus, expanding participation in CT may be a way
to access cuttingedge medications that would otherwise not be covered by these healthcare
systems.[9]
Several studies have shown that, even though patients are inclined to participate
in clinical trials, very few do so.[4]
[7]
[8] Therefore, there is a large gap between the patients' willingness to participate
in a CT and the actual participation rates, suggesting that barriers to CT participation
are numerous and frequently insuperable.
In our study, results showed that overall about 85% of respondents would participate
in a cancer trial. Of all respondents, 99.9% believe that clinical research can contribute
positively to the advancement of cancer treatment and 96% affirmed that have already
had some information on clinical research. On the other hand, only 6.9% of respondents
reported previously participation on CT, and about 10% answered that they knew someone
who participated in a CT (e.g. friend, family or other).
Table 1
Patient's reasons to participate or not in clinical trials
|
Reasons to participate or not in clinical trials
|
Patients[*] (%)
|
|
Reasons to participate in clinical trials
|
|
|
Improvement in treatment / Cure
|
(47.2)
|
|
Personal experience/motivation
|
(32.6)
|
|
Help to other patients
|
(30.3)
|
|
Would participate if ensured that the trial would not add any additional risk
|
(5.5)
|
|
Access to novel treatments
|
(3.7)
|
|
Clinical trial subject
|
(2.3)
|
|
Special interest in the subject/Prevention
|
(2.3)
|
|
Reasons NOT to participate in clinical trials
|
|
|
Lack of information
|
(32.4)
|
|
Lack of opportunity
|
(29.4)
|
|
Fear
|
(14.7)
|
|
Consider their treatment well studied
|
(11.8)
|
|
Inconclusive
|
(5.9)
|
|
Negative past experiences
|
(2.9)
|
* Patients answers were categorized from open-answer; Patients' answer could fulfill
more than one reason.
The data indicate that lack of available information, including low participation
of physician on instructing their patients, are the current major barriers on CT in
Brazil. This is in line with recent discussions on the same subject, which are few
worldwide[10]
[11]. Currently, the treatment decision-making process based on the patient's perspective
receives more and more emphasis. Patient-centered medicine is practice with patients
participating in their own healthcare decisions and in researches informing such decisions.[12] Therefore, giving the opportunity and the necessary tools for patients to make a
well-informed decision to participate or not in CTs is vital.[8] Improvements in patient understanding of trial methodology and patient safety could
improve interest in and recruitment to CTs.[1]
In this scenario, the role of patient groups is fundamental. Patients' groups provide
oriented education, advocacy, and support services, playing an important role in patient's
perspective, increasing quality of life, emotional support and other outcomes.[13] In oncology, they also help understanding patients' needs and disease awareness,
which may improve prevention, early detection, quality-oflife and legal rights, reducing
the burden of the disease.[14] Hence, these groups are of paramount importance in educating and raising patients'
awareness regarding CT, thus contributing to filling the gap between willingness to
participate and actual participation in cancer trials.
Information is a valuable tool in cancer care, and patient groups are important -
and reliable - vehicles for disseminating this information. Thus, they can be an effective
communication channel on cancer trials, clarifying patients' doubts, informing them
about new researches, and even referring patients to CTs that best fit their condition.
Cancer patient groups worldwide engage in the design of CTs and tackle the inequalities
of access to treatment and information. They are important tools for patients to gain
access to medicines, and also in the development of CTs, influencing their design
and helping to increase their accrual.[15]
To date, little is known about Brazilian patient's perception regarding CT. This study
sought to describe the overall perception of patients on clinical research in Brazil
and showed that lack of information impairs patients' participation in cancer trials.
Despite its limitations, such as low participation rate, recruitment only among Oncoguia's
website users, absence of gender and tumor specification, it presented preliminary
data that can be useful for planning and developing strategies for recruiting participants
to CTs, as well as for the design of studies themselves.[16] It also shows that a crucial component for increasing accrual should focus on the
process of informing and educating patients about clinical research - a role that
must be played by patients' advocacy groups too.
CONCLUSION
This survey, even with its limitations aforementioned, demonstrates that respondents
associate clinical research as an option in cancer treatment. However, only a small
number of respondents have participated previously in a CT. Besides, the internet
was the main tool to learn about CTs. The data indicate that lack of available information,
including low participation of physician on instructing their patients, are the current
major barriers on CT in Brazil on patient perspective. Besides the improvements needed
on regulation and approval timelines, on patient/CT subject perspective, the improvement
of physician and patient awareness are potential solutions. Thus, strategies are needed
to improve communication between patient and physician.
Questionnaire applied (in Brazilian Portuguese)
-
O que é pesquisa clínica para você?
-
Como soube da pesquisa clínica?
-
Você acha que a pesquisa clínica contribui para o avanço do tratamento do câncer?
-
Se sim, de que maneira?
-
□ Aumento do conhecimento científico
-
□ Melhora do tratamento
-
□ Busca da cura
-
□ Melhora da qualidade de vida
-
□ Para ter uma nova opção de tratamento
-
Você participaria de uma pesquisa clínica em câncer?
-
○ Se sim, por que?
-
○ Se não, por que?
-
Você conhece alguém que já participou de uma pesquisa clínica em câncer?
Questionnaire translated to English
-
In your opinion, what is clinical research?
-
How did you know about clinical research?
-
Do you think clinical research contributes to advances of cancer treatment?
-
If yes, in which manner(s)?
-
□ Increase of scientific knowledge
-
□ Treatment improvement
-
□ Seeking cure
-
□ Improvement in quality of life
-
□ To be a novel treatment option
-
Would you participate in a clinical trial in cancer?
-
○ If yes, why?
-
○ If not, why?
-
Do you know anyone that already parcipated in a cancer clinical trial?
Bibliographical Record
Guilherme Silva Julian, Christiane Bueno, Renata Eiras Martins, Luciana Holz Camargo
de-Barros. Barriers to participation in clinical trials: cross-sectional study on
perceptions of oncology patient advocacy group webpage in Brazil. Brazilian Journal
of Oncology 2019; 15: e-20190016.
DOI: 10.5935/2526-8732.20190016
