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Hope for a cure and altruism are the main motives behind
participation in phase 3 clinical cancer trials
T. GODSKESEN, RN,PHD STUDENT,Department of Public Health and Caring Sciences, Centre for Research Ethics &
Bioethics, Uppsala, M.G. HANSSON, PROFESSOR, Centre for Research Ethics & Bioethics, Uppsala, P. NYGREN, MD,
PROFESSOR, Department of Radiology, Oncology and Radiation Science, Oncology, Uppsala University Hospital,
Uppsala, K. NORDIN, PROFESSOR, Department of Public Health and Caring Sciences, Uppsala, Sweden and Depart-
ment of Global Public Health and Primary Care, University of Bergen, Bergen, Norway, & U. KIHLBOM, PHD,SENIOR
LECTURER, Centre for Research Ethics & Bioethics, Uppsala, Sweden
GODSKESEN T., HANSSON M.G., NYGREN P., NORDIN K. & KIHLBOM U. (2014) European Journal of
Cancer Care
Hope for a cure and altruism are the main motives behind participation in phase 3 clinical cancer trials
It is necessary to carry out randomised clinical cancer trials (RCTs) in order to evaluate new, potentially useful
treatments for future cancer patients. Participation in clinical trials plays an important role in determining
whether a new treatment is the best therapy or not. Therefore, it is important to understand on what basis
patients decide to participate in clinical trials and to investigate the implications of this understanding for
optimising the information process related to study participation. The aims of this study were to (1) describe
motives associated with participation in RCTs, (2) assess if patients comprehend the information related
to trial enrolment, and (3) describe patient experiences of trial participation. Questionnaires were sent to 96
cancer patients participating in one of nine ongoing clinical phase 3 trials at the Department of Oncology,
Uppsala University Hospital in Sweden. Eighty-eight patients completed the questionnaire (response rate
92%); 95% of these were patients in adjuvant therapy and 5% participated in clinical trials on palliative care.
Two main reasons for participation were identified: personal hope for a cure and altruism. Patients show
adequate understanding of the information provided to them in the consent process and participation entails
high patient satisfaction.
Keywords: cancer, clinical trials.
INTRODUCTION
Advances in cancer treatment are evidently dependent on
the successful recruitment of cancer patients to clinical
trials. From a patient perspective, participation in clinical
trials is a potentially important decision and various
factors may influence satisfaction with their decision.
Therefore, it is necessary to analyse factors that are rel-
evant for patient participation in such trials.
The randomised clinical trial (RCT) is the heart of
evidence-based medicine (EBM) and is the gold standard
method for establishing the clinical efficacy of a new
therapy or comparing new treatments to standard treat-
ment (Fisher 1991; Rosenberg & Donald 1995). To partici-
pate in an RCT, the patients need to meet the inclusion
criteria to be eligible for enrolment. After being informed
about the study, the patient needs to voluntarily provide
consent: written, dated and signed. Patients participating
in the trial will then be randomly allocated to one of two
or sometimes more treatment groups and be closely moni-
tored. Individual patients participating in a RCT may not
Correspondence address: Tove Godskesen, Department of Public Health
and Caring Sciences, Centre for Research Ethics & Bioethics, Box 564, 751
22 Uppsala, Sweden (e-mail: tove.godskesen@crb.uu.se).
Accepted 2 January 2014
DOI: 10.1111/ecc.12184
European Journal of Cancer Care, 2014
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Original article
© 2014 John Wiley & Sons Ltd
benefit directly themselves. Non-participants who do not
meet all of the inclusion criteria will be offered the stand-
ard of care and best-proven treatment available. Patients
in the experimental group will be offered the treatment
theorised to have similar or better effect than that pro-
vided in the control group (Levine 1993).
Before patients participate in the research, the physicians
need to ensure that the patients know their treatment
options and relevant facts necessary to make informed
decisions. Various ethical declarations, principles and
guidelines concerning participation in research include
several essential elements (e.g. voluntariness and the dis-
closure of adequately provided and understood relevant
information) in order to give informed consent (Beauchamp
& Childress 2009). Informed consent is not a signature on
a piece of paper; it should reflect a process of advanced
communication between a patient and the research person-
nel. It is also defined as an ‘active process through which
both parties share information and the participant at any
time can freely decide whether to withdraw from or con-
tinue to participate in the research’ (NBAC 2001). It is
therefore important that the clinical trial information
is clearly explained in writing by the research physicians
and nurses and adequately communicated to the cancer
patients.
The most frequently cited preference and motivation
for trial participation is personal health benefit. Another
common reason for participating is to contribute to
research and society as a whole (Ellis et al. 2001). Misun-
derstanding the purpose of the design of clinical research is
often called ‘therapeutic misconception’ and is described
as the failure to ‘appreciate the distinction between the
imperatives of clinical research and standard treatment’
(Appelbaum et al. 1982, 2012). Discussions have therefore
continued regarding how to minimise this misconception.
Well-informed and active patients are less likely to regret
their decision to participate (Stryker et al. 2006; Mancini
et al. 2012), and are more satisfied with their participation
(Coyne et al 2003). However, added information about
risks, benefits of trial participation (Stryker et al. 2006) and
increased knowledge do not seem to make the patients
more likely to participate (Garcea et al. 2005).
Demographic variables are reported as influencing
patients’ decision-making as education, financial status,
severity of the disease and ability to communicate
(Verheggen et al. 1998; Ellis et al. 2001; Biedrzycki 2011).
Swedish cancer care and research have an internation-
ally high standard and homogeneity. Healthcare is
delivered through a tax-funded system to all inhabitants.
Consequently, in a Swedish clinical research context,
financial incentives are not an issue for patients as they do
not need to take cost into consideration when making
decisions about cancer care.
There is a need for evaluating cancer patients’ prefer-
ences, motivation and satisfaction with the decision to
participate in RCTs (Medicine 2002; Biedrzycki 2010;
Socialstyrelsen 2011). A better understanding of cancer
patients’ motivation for participating in RCTs, their
understanding and experiences may identify how patients
receive and weigh information in the process of deciding
to participate. There is a lack of empirical studies focus-
ing on decision-making among patients for clinical trial-
participation in a Swedish cancer context. Therefore,
the main aim of this study was to investigate patients’
motives for participating in phase 3 RCTs. Additional
aims were to find out how patients perceived the informa-
tion concerning the trials and to describe their experiences
related to their trial participation.
MATERIAL AND METHODS
Study subjects
All adult cancer patients participating in one of nine
ongoing academic or pharmaceutical company-sponsored
randomised phase 3 clinical trials in an adjuvant or pal-
liative setting at the Department of Oncology, Uppsala
University Hospital, Sweden, were invited to participate.
Seven of these nine clinical trials were in an adjuvant
setting (breast cancer 2, gastrointestinal cancer 2, prostate
cancer 1, melanoma 1, gastric cancer 1; Table 1). Two of
the clinical trials were for palliative treatment of meta-
static colorectal cancer or lymphoma respectively.
Invited patients participated in one of the RCTs
between 2009 and 2012. Patients were invited to answer
the questionnaire (see below) between January 2012
and April 2012. Cancer patients participating in clinical
trial participants in Sweden are not offered any reim-
bursement, except for their expenses related to participa-
tion (e.g. travel costs). The study was approved by the
Regional Ethical Review Board in Uppsala, Sweden (Dnr
2011/018).
Procedure
The 96 patients identified were sent the questionnaire
together with a combined introduction and consent letter
and a stamped-addressed envelope. As stated in the patient
information, the patients consented to be included in the
study by returning the questionnaire. Two reminders were
posted to those who had not returned the questionnaire,
the first within 3 weeks and the second after 5 weeks.
GODSKESEN ET AL.
© 2014 John Wiley & Sons Ltd2
Questionnaire
Data were collected using a study specific questionnaire
about the decision-making process, trial information and
experiences from trial participation. The questionnaire
was based on the questionnaire, Patient Understanding
of Research, developed by Hutchison et al. (2007). Addi-
tional items were generated based on interviews with
three cancer patients participating in an RCT. The draft
questionnaire was developed and pre-tested on a sample of
four patients participating in a RCT (Streiner & Norman
2008). On the basis of this pretesting, the questionnaire
was revised and administered to a multidisciplinary team
(including an oncologist, a psychologist, a philosopher,
bioethicists and a nurse) who analysed the items and
discussed scale design and how questions/statements
were worded and could be made clearer. After modifica-
tions, five patients in RCTs filled out a pilot version
of the questionnaire. No further reason for revision
was identified at this point. The final questionnaire
instrument consisted of 60 items (statements) and
addressed four areas in relation to trial-participation: the
decision-making process, information, understanding and
experiences.
For responses to most of the items a six-point Likert
scale was used (with end-points strongly disagree –
strongly agree). For items related to personal motives and
preferences, a visual analogue scale (VAS, 0–100) was
used. The last two items were used to assess the general
health and quality of life the last week. The question-
naire took approximately 20 min to complete.
Data analysis
The Statistics Package for the Social Sciences, v20
(SPSSv20) was used for the analysis. Data were summa-
rised descriptively to determine the proportion of indi-
vidual responses to each question. Data related to motives
for participation in Figure 1 are expressed as medians. To
simplify data interpretation, results are presented as the
range of patients scoring the two most extreme values:
disagree (scores 1–2) and agree (scores 5–6). The well-used
Likert scale has been discussed as to whether it provides
ordinal or interval date. The VAS scale in this study was
analysed using non-parametric statistical methods and
seen as an ordinal scale. Therefore, the data are presented
as medians. Full data are available in the appendix.
RESULTS
Description of the participants
All cancer patients (n=96) participating in a RCT at the
Dept. of Oncology, Uppsala University Hospital, Sweden,
at the time for recruitment (n=96) were invited to par-
ticipate and 92% (n=88) accepted participation by com-
pleted the questionnaire. Sixty per cent of the respondents
were female, and the mean age was 61 (SD =9.1 years,
range =39–80 years). Almost half of the respondents, 48%,
Table 1. Overview of tumour diagnosis, stage and study type for patients included (number of patients)
Diagnosis
Disease setting
Trial outlineCurative Palliative
Breast cancer 42 RCT of short or prolonged adjuvant treatment with trastuzumab added to chemotherapy
Breast cancer 6 RCT of tailored or standard adjuvant chemotherapy
Prostate cancer 20 RCT of adjuvant chemotherapy following radical radiotherapy
Melanoma 8 RCT of two different adjuvant treatments for operated high-risk melanoma
Colorectal cancer 3 RCT of second-line palliative chemotherapy with or without a new angiogenesis inhibitor
Rectal cancer 5 RCT of two different sequences of radiotherapy, surgery and chemotherapy for locally
advanced disease
Gastric cancer 1 RCT of neo-adjuvant chemotherapy followed by postoperative radio-chemotherapy or
chemotherapy
Pancreatic cancer 2 RCT of two different adjuvant chemotherapy regimens following radical surgery
Lymphoma 1 RCT of two different treatments for lymphoma refractory to standard therapy
RCT, randomised controlled trial.
9.7
8.7
6.2
4.6 4.1
2.4
0.7
0
1
2
3
4
5
6
7
8
9
10
9.7
Figure 1. The cancer patient reason(s) for participating in the
trial. Each of the eight possible reasons for participating in the
trial is listed on the X-axis.
Main motives behind participation in clinical cancer trials
© 2014 John Wiley & Sons Ltd 3
were college or university educated 39% were employed
and 43% retired. The majority (74%) was married/
cohabitating, 93% had children and 18% had children
under the age of 18. More than half, 64%, of the respond-
ents had no earlier history of trial participation. Demo-
graphic characteristics are presented in Table 2.
Multifaceted motives for trial participation
Most of the participants reported one major reason for
participation in RCTs, and some cited several reasons. Of
eight possible reasons given for participation in the trial
(Fig. 1, expressed as the median, highest score 10), two
statements achieved identical and very high agreement:
‘the hope of getting well/slowing the disease’ (median 9.7)
and ‘contributing to research that can help others in the
future’. There was also a high level of agreement with the
motive ‘access to extra examinations’ (median 8.7). Fewer
respondents cited ‘access to better care within healthcare’
(median 6.0) and ‘to give something back in return for the
help I’ve received from healthcare/society’ (median 4.6)
as an important reason for participating. Most of the
respondents did not experience any pressure from their
doctor (median 4.1) or from relatives and friends (median
2.4). The respondents disagreed with the statement ‘it felt
like a duty to help’ (the median 0.7).
When finally asked: ‘Which of these reasons was the
most important to you?’ hope of personal medical benefit
was the most frequently cited motivation (41%). Contrib-
uting to research that could help other people was the
second most significant reason given by the respondents
(28%) and the third reason was access to better examina-
tions (9%). Nearly 20% of respondents reported two to
four sets of reasons for participating in the clinical trial
(a combination of getting well, helping others, access to
examinations, giving something back in return and a duty
to help).
The majority of the respondents had a preference for
shared decision-making regarding participation in cancer
trials. Slightly more than half of the respondents preferred
to share the responsibility for making the decision. In
most cases, this shared decision-making was done in con-
sultation with a doctor, family/relatives or the research
nurse (Table 3).
Patient knowledge about trials
Most of the respondents said that they were satisfied
with the information they received, and more than 80%
reported that they had received sufficient and relevant
information (Table 4). They answered that they under-
stood both the oral and written information, including all
medical terms. They also answered that they understood
how the treatment would be performed and followed up,
and that they had no assistance from anyone in under-
standing the written information. A large proportion of
respondents (44%) did not find it hard to ask the physi-
cians questions. About 20% needed more information on
what participation entailed. These patients also found it
hard to ask questions because they did not know what to
ask about.
There was a high level of agreement (98%) with the
statement ‘the most important purpose for conducting a
trial like the one I am participating in is to improve the
treatment methods’. However, regarding the statement
‘new treatments are tested on patients only if it is believed
that the new treatment has no side-effects’ only half (46%)
of the respondents answered correctly and 34% strongly
believed that new treatments are investigated in trials
only if there is no risk of side-effects. Two of 10 patients
(20%) did not strongly agree or strongly disagree but
Table 2. Patient characteristics (N=88)
Characteristics n%
Age, years
Mean 61.1
Range 39–80
Sex
Male 35 39.8
Female 53 60.2
Marital status
Married/cohabitating 66 73.8
In relationship, but living apart 9 10.7
Single 13 15.5
Have children 81 93.1
Children<18 years 16 17.7
Education
Elementary school 13 14.8
Upper-secondary school or vocational 32 36.4
University/college 42 47.7
Missing 1 1.1
Current main occupation
Employed 34 38.6
On sick leave 8 9.1
Unemployed 2 2.3
Disability pension 5 5.7
Retired 38 43.2
Missing 1 1.1
Types of cancer
Breast 48 54.5
Prostate 20 22.7
Colorectal 8 9.0
Pancreas, lymphoma & stomach cancer 4 4.7
Malign melanoma 8 9.0
Previous trial experience
Yes 32 36.4
No 56 63.6
GODSKESEN ET AL.
© 2014 John Wiley & Sons Ltd4
answered between the two extremes. Sixty per cent agreed
with the statement ‘I understood what side-effects the
treatment in the trial could cause’, while circa 20% did
not agree with the statement. Half of the respondents,
54%, did not see side-effects as a drawback of trial partici-
pation. Almost all the respondents, 90%, correctly agreed
with the statement ‘in a randomised trial, patients are
randomly allocated to different treatment alternatives in
order to compare effects and side-effects between the dif-
ferent treatment alternatives’. With regard to the state-
ment ‘the treatment I receive in the trial is determined
randomly (called randomisation)’ 86% correctly agreed.
Twelve of 88 respondents (14%) answered ‘do not
know’ or left the question blank and nearly 30% of the
Table 3. Why patients agreed to participate in RCTs
Reasons for participation (response rate N=)
Mean
value
Very
important
Not
important
The hope of getting well/that the cause of the disease would be slowed (86) 9.7 26 (30) 0 (0)
That I was contributing to research that can help others in the future (86) 9.7 21 (24) 0 (0)
That I had access to extra exams (83) 8.7 8 (10) 0 (0)
That I would have access to better care within healthcare (82) 6.2 4 (5) 2 (2)
To give something back in return for the help I have received from healthcare/society (86) 4.6 5 (7) 8 (9)
That my doctor thought so (83) 4.1 0 (0) 7 (8)
Those close to me thought I should (85) 2.4 6 (1) 8 (9)
It felt like a duty to help (85) 0.7 1 (1) 14 (17)
Table 4. Overview of items regarding information given before participation
Information before participation (response rate N=) Agree* Disagree*
The most important purpose of conducting a trial like the one I am participating in is to improve the
treatment methods (85)
84 (98) 1 (1)
If I do not want to participate in a trial I will be offered treatment that is normally given for precisely
my disease (83)
82 (99) 0 (0)
Participating in a trial is voluntary – completely without conditions (87) 82 (95) 2 (2)
I understood the written information (83) 78 (94) 1 (1)
In a randomised trial, patients are randomly allocated to different treatment alternatives in order to
compare effects and side-effects between the different treatment alternatives (85)
78 (90) 3 (4)
I understood the oral information (82) 76 (93) 1 (1)
I understood how the treatment would be performed and followed up (86) 76 (88) 3 (4)
I can withdraw from a trial at any time – without giving a reason (86) 75 (87) 9 (11)
The treatment I receive in the trial is determined randomly (called randomisation) (86) 74 (86) 10 (12)
I thought the information I received was sufficient (83) 71 (85) 1 (1)
I feel I was given enough time to decide whether I wanted to participate or not (86) 69 (80) 5 (6)
The research nurse associated with the trial was the one who gave me the best information about the trial (83) 54 (66) 12 (15)
The doctor associated with the trial was the one who gave me the best information about the trial (83) 51 (62) 12 (15)
I understood what side-effects the treatment in the trial can cause (84) 50 (60) 14 (17)
I decided to participate in the trial after talking about it with the doctor (87) 46 (53) 26 (30)
I decided to participate in the trial after talking about it with those close to me (86) 45 (53) 37 (42)
I got help from my doctor/research nurse in understanding the written information (83) 39 (47) 34 (39)
The trial I am participating in is being conducted by healthcare/society without the participation of
pharmaceutical companies (76)
32 (43) 26 (34)
I decided to participate in the trial after talking about it with the research nurse (86) 32 (37) 39 (45)
In the trial I am participating in, the doctor chooses the treatment for me (84) 32 (39) 48 (57)
New treatments are tested on patients only if it is believed that the new treatment has no side-effects (83) 28 (34) 38 (46)
The trial I am participating in is being conducted in collaboration with a pharmaceutical company (75) 26 (36) 34 (45)
I decided to participate in the trial without talking to anyone else at all (86) 26 (30) 53 (61)
I would have liked to have more information on what it entails to participate in the trial (83) 20 (24) 49 (59)
I notified the doctor of my decision to participate in the trial (86) 20 (19) 66 (76)
I can withdraw from a trial only if I experience side-effects (85) 19 (22) 64 (76)
It was hard to ask questions because I did not know what to ask (80) 17 (22) 35 (44)
I believe the risk of side-effects is a drawback of trial participation (84) 14 (17) 45 (54)
I got help from someone (within or outside the family) in understanding the written information (83) 12 (15) 67 (82)
It is expected of me that I participate in a trial (86) 8 (10) 61 (70)
I can withdraw from a trial only if I have a good reason (84) 7 (9) 72 (86)
*Values are the number (%).
Main motives behind participation in clinical cancer trials
© 2014 John Wiley & Sons Ltd 5
respondents incorrectly agreed that the trial was con-
ducted in collaboration with a pharmaceutical company.
Almost all patients, 95%, agreed that trial participation
is voluntary, entirely without conditions. All but one
respondent could identify that they would be offered
standard treatment if not participating in the trial.
Experiences of information and trial participation
Respondents tended to report high levels of satisfaction
with trial participation (Table 5). Most respondents (80%)
agreed that the trial information corresponded well with
the trial experience. When asked if the doctor took her/
his time in explaining the content of the trial, circa three
quarters of the respondents thought the doctor did so.
More than 60% perceived the doctors and nurses as inter-
ested in the participants’ experiences. About half of the
respondents agreed with the statement ‘contact with the
research nurse has allowed me to receive better care than
I would have received outside the trial’.
Regarding the statement ‘I worry that participation in
the trial can hurt me’ most of the respondents (74%)
disagreed. Similarly, when asked if they worried that par-
ticipation could carry a risk of receiving a lower quality
treatment than they would otherwise receive, most were
not worried (93%). Respondents seemed optimistic about
the possibility of better medical care in the trial than in
standard care. Forty-five per cent of the respondents disa-
greed with the statement ‘I receive better medical treat-
ment and better care by participating in the trial than I
would if I were treated outside the trial’.
Nearly all respondents (96%) reported that they were
satisfied with their participation in the clinical trial; only
one respondent regretted taking part. The vast majority
of respondents (82%) answered that they were positively
inclined to recommend others to participate in cancer
trials. Most of the respondents (70%) answered that they
did not feel pressured into participating, although, 10%
felt expected to participate. Almost half of the respond-
ents were willing to participate in trials supported by a
pharmaceutical company. Thirty per cent indicated less
desire to participate in such sponsored trials compared
with healthcare/society conducted trials.
DISCUSSION
The results show that the two most significant motives
for participating in phase 3 clinical trials are the hope
for a cure and to contribute to medical knowledge that
can help future patients. Better access to cancer-specific
examinations was also an important motive.
Most respondents indicated that they had mixed
motives when deciding to participate. Participants seem
to have been influenced by the strong personal motive of
medical benefit in terms of a cure while, at the same time,
pragmatically reflecting that even if they did not person-
ally benefit at least they had helped others by participat-
ing. There is also a possibility that patients regard clinical
trials as a way of receiving better than standard treatment.
These results confirm and strengthen the findings of pre-
vious studies that patients are motivated both by the hope
of personal health benefit and by altruism when partici-
pating in RCTs (McCann et al. 2010; Shah et al. 2010).
In Scandinavian healthcare, autonomy is one of the
basic ethical principles, and the patient is integrated in
and a part of the decision-making process. More than 80%
Table 5. Overview of items regarding experiences of participation
Experiences of participation (response rate N=) Agree* Disagree*
My experience of participating in the trial has corresponded well with the information I have received about
the trial (84)
67 (80) 3 (3)
The doctor took his time in explaining the content of the trial (83) 60 (73) 7 (8)
Based on my experience, I would recommend to others that they participate in cancer treatment trials (80) 65 (82) 5 (6)
The research nurse has been interested in my experiences of the treatment in the trial (82) 56 (69) 9 (11)
The doctors have been interested in my experiences of the treatment in the trial (84) 54 (64) 11 (13)
Contact with the research nurse has allowed me to receive better care than I would have received outside
the trial (80)
38 (48) 20 (25)
I am taken better care of within healthcare because I am participating in a trial (84) 29 (35) 38 (45)
If a pharmaceutical company finances a trial, my desire to participate is lower compared with if it is
healthcare/society conducting a trial (84)
25 (30) 41 (49)
I sensed expectation from the doctor that I would consent to participate in the trial (87) 10 (12) 61 (70)
I worry that participation in the trial can hurt me (85) 7 (8) 62 (74)
I worry that my participation in the trial carries a risk that I will receive lower quality treatment than I
otherwise would have received (86)
2 (2) 80 (93)
I have regretted consenting to participate in the trial (83) 1 (1) 80 (96)
*Values are the number (%).
GODSKESEN ET AL.
© 2014 John Wiley & Sons Ltd6
of the patients felt they had an adequate amount of time to
decide about trial participation and 70% sensed no expec-
tation of agreeing to participate. Most of the respondents
in this study adopted an active decision-making process in
terms of discussing it with family members or the doctors.
However, one quarter of the respondents found it hard
to ask questions; this was related to not knowing what to
ask. The respondents also indicated a need for additional
information about participation in the clinical trial. Side-
effects are common in cancer treatments, but they vary
depending on the type of cancer and treatment. Most
cancer treatments include side-effects and risks, and new
treatments may also have unknown side-effects. There-
fore, it is noteworthy that many patients indicated that
cancer trials should not be performed if there are potential
side-effects. In addition, two of ten patients were not
aware of the side-effects the trial treatment could cause.
Only about half of the participants understood what side-
effects the trial could cause. This finding has important
implications regarding information and consent proce-
dures for participation in clinical trials since, according to
ethics and guidelines, patients should be aware of risk for
side-effects. This may imply that research personnel need
to improve information regarding side-effects to ensure
that the patients adequately understand the information
when informed consent is given. Furthermore, well-
informed patients are less likely to experience regretting
participating in a trial (Stryker et al. 2006).
Most of the respondents comprehended the nature
of the clinical trial to an acceptable level and the entire
process around participation seemed to work well.
Respondents demonstrated knowledge of randomisation
in clinical trials, but some aspects of participation were
inadequately understood. Some patients did not under-
stand the study design in terms of responsibility for the
research. Notably, 14% of the respondents left the ques-
tion blank or answered that they did not know, and more
than 30% answered that the clinical trial was sponsored
by a pharmaceutical company when in fact the trial was
funded by public healthcare. This may indicate a gap in
the information on sponsorship or that patients do not pay
attention to such information. Previous research has con-
cluded that it is important for participants to know how
trials are funded and that this information should be
included in the information given to potential study par-
ticipants before they agree to participate (Kim et al. 2004).
Poor understanding of the principal responsibility for
the trial can of course be related to recall bias. Some of the
patients took part in a clinical trial in 2009, opening
for recall bias (Gerhard 2008). Other findings are that
the respondents were satisfied with their trial decision,
trusted the medical system and did not worry that the trial
would hurt them. These data support results from previ-
ous studies, which showed high trial-related satisfaction
(Stryker et al. 2006).
Several demographic factors such as gender, age, educa-
tion and state of health have been found to correlate with
the decision to participate in clinical trials (Verheggen
et al. 1998; Ellis et al. 2001; Biedrzycki 2010). In this
current study, more than half of the participants were
women with breast cancer, mean age 61 (range of age
39–80), well educated, married/cohabitating and had chil-
dren. Cancer patients treated with adjuvant chemotherapy
that thus had a good prognosis also dominated this trial
population. It was hypothesised that willingness to par-
ticipate in RCTs may be related to low anxiety given that
the survival rate and prognosis for recovery is good. The
sample group is representative of the general cancer popu-
lation in terms of gender, age and incidence of breast
and prostate cancer, except for level of education. Almost
half of the patients in this study had a university-level
education. According to Ellis et al. (2001), patients with
higher education and socio-economic status are more able
to comprehend knowledge and understand the concept of
research.
The answers to questions in a survey may be influenced
by many factors, such as self-image or expectations of
what researchers are interested in. To add ‘Altruism’ as
a reason for participation may be a way to enhance one’s
self-image. However, altruism appeared spontaneously as
a motive for trial participation in the pilot test. Thus, we
conclude that most patients participated in their clinical
trial due to hope for therapeutic benefit and altruism.
Altruism is an important moral value and helping
others can be of an important meaning to these patients.
One may raise the question if the respondents cite altru-
ism as one of the main reasons for participation due to the
fact that they are treated in adjuvant chemotherapy. The
altruistic reasons to help others by contributing towards
medical knowledge may be easier to relate to for patients
in adjuvant studies since they are less vulnerable and the
likelihood for cure is significant, compared with patients
in the palliative setting.
In Sweden, socio-economic factors have become of
increasing importance and it is known that the highly
educated and those with higher socio-economic status
have a greater claim on healthcare. Therefore, age and
level of education may explain why the majority of
patients answered the statements correctly. Cultural
differences and social factors, such as difficulties with
the Swedish language, have been found to hamper com-
munication between potential participants and clinicians
Main motives behind participation in clinical cancer trials
© 2014 John Wiley & Sons Ltd 7
(Murthy et al. 2004). In this study, there was little ethnic
variation. This is consistent with a systematic review
by Biedrzycki (2010), who found reduced trial participa-
tion among ethnic minorities. This can be related to
the inclusion and exclusion criteria in the study proto-
col. A number of factors can add to the observed socio-
demographic discrepancy in cancer trials. First, stringent
eligibility criteria play an important role in exclusion of
patients with co-morbidities. Second, language barriers
can exclude ethnic minorities. Third, willingness to par-
ticipate in clinical trials may differ based on ethnicity,
age and education. Thus, the generalisability of our
results may be limited to study populations with similar
characteristics.
The study has several strengths. The response rate was
high, the patients were recruited from many different
clinical trials and a number of diagnoses were included.
The questionnaire was developed and validated for this
study and population and the response rate was high (92%)
which indicates that the questionnaire was feasible
and that the patients regarded it as relevant to respond to.
However, high response rates do not necessarily ensure
external validity. The study also has some weaknesses; it
was conducted at a single site and is retrospective. There-
fore, the respondents may have been affected by recall
bias. This may limit the generalisability of findings (exter-
nal validity). Even if the results of this study cannot be
generalised to all cancer patients in RCTs, it can at least
be generalised to other patients in comparable clinical
cancer trial situations, with a trial population, which
has a relatively high education level, as in this Swedish
context. Future studies involving a varied group of
patients from a broader geographic region should clarify
and provide more definitive results.
In conclusion, results from this retrospective study
show that cancer patients had mixed motives when
participating in RCTs but the hope of potential health
benefits and a willingness to help others were the main
driving forces. The trial information process seemed
to work properly and trial participation entailed high
satisfaction.
ACKNOWLEDGEMENTS
The authors wish to thank the trial participants for taking
the time to participate in this study. We also thank
Katarina Schoning at the Oncological Research and Devel-
opment Unit at Uppsala University Hospital for support
during the working process. The Swedish Cancer Society
provided financial support.
DISCLOSURE
The authors have declared no conflicts of interest.
REFERENCES
Appelbaum P.S., Roth L.H. & Lidz C.
(1982) The therapeutic misconception:
informed consent in psychiatric research.
International Journal of Law and Psy-
chiatry 5, 319–329.
Appelbaum P.S., Anatchkova M., Albert K.,
Dunn L.B. & Lidz C.W. (2012) Therapeu-
tic misconception in research subjects:
development and validation of a measure.
Clinical Trials 9, 748–761.
Beauchamp T.L. & Childress J.F. (2009)
Principles of Biomedical Ethics. Oxford
University Press, New York, NY, USA.
Biedrzycki B.A. (2010) Decision making
for cancer clinical trial participation: a
systematic review. Oncology Nursing
Forum 37, E387–E399.
Biedrzycki B.A. (2011) Factors and out-
comes of decision making for cancer
clinical trial participation. Oncology
Nursing Forum 38, 542–552.
Coyne C.A., Xu R., Raich P., Plomer K.,
Dignan M., Wenzel L.B., Fairclough D.,
Habermann T., Schnell L., Quella S.,
Cella D. & Eastern Cooperative Oncol-
ogy G. (2003) Randomized, controlled
trial of an easy-to-read informed consent
statement for clinical trial participation:
a study of the Eastern Cooperative Oncol-
ogy Group. Journal of Clinical Oncology
21, 836–842.
Ellis P.M., Butow P.N., Tattersall M.H.,
Dunn S.M. & Houssami N. (2001)
Randomized clinical trials in oncology:
understanding and attitudes predict will-
ingness to participate. Journal of Clinical
Oncology 19, 3554–3561.
Fisher B. (1991) On clinical trial participa-
tion. Journal of Clinical Oncology 9,
1927–1930.
Garcea G., Lloyd T., Steward W.P.,
Dennison A.R. & Berry D.P. (2005)
Differences in attitudes between pati-
ents with primary colorectal cancer
and patients with secondary colorectal
cancer: is it reflected in their willingness
to participate in drug trials? European
Journal of Cancer Care 14, 166–170.
Gerhard T. (2008) Bias: considerations for
research practice. American Journal of
Health-System Pharmacy: AJHP: Official
Journal of the American Society of
Health-System Pharmacists 65, 2159–
2168.
Hutchison C., Cowan C. & Paul J. (2007)
Patient understanding of research: devel-
oping and testing of a new questionnaire.
European Journal of Cancer Care 16,
187–195, quiz 195–186.
Kim S.Y.H., Millard R.W., Nisbet P., Cox C.
& Caine E.D. (2004) Potential research
participants’ views regarding researcher
and institutional financial conflicts of
interest. Journal of Medical Ethics 30,
73–79.
Levine R.J. (1993) Ethics of clinical trials.
Do they help the patient? Cancer 72,
2805–2810.
Mancini J., Genre D., Dalenc F., Ferrero
J.M., Kerbrat P., Martin A.L., Roche H.,
Maylevin F., Tarpin C., Viens P.,
Gamet C. & Julian-Reynier C. (2012)
Patients’ regrets after participating in a
randomized controlled trials depended
on their involvement in the decision
making. Journal of Clinical Epidemiol-
ogy 65, 635–642.
McCann S.K., Campbell M.K. & Entwistle
V.A. (2010) Reasons for participating in
randomised controlled trials: conditional
altruism and considerations for self.
Trials 11, 31. [Electronic Resource].
GODSKESEN ET AL.
© 2014 John Wiley & Sons Ltd8
Medicine I.O. (2002) Responsible Research:
A Systems Approach to Protecting
Research Participants. The National
Academies Press, Washington, DC, USA.
Murthy V.H., Krumholz H.M. & Gross C.P.
(2004) Participation in cancer clinical
trials: race-, sex-, and age-based dispari-
ties. JAMA: The Journal of the American
Medical Association 291, 2720–2726.
NBAC. (2001). Ethical and policy issues in
research involving human participants.
Available at: http://bioethics.georgetown
.edu/nbac/human/oversumm.pdf (cited
2001).
Rosenberg W. & Donald A. (1995) Evidence
based medicine: an approach to clinical
problem-solving. BMJ (Clinical Research
Ed.) 310, 1122–1126.
Shah J.Y., Phadtare A., Rajgor D., Vaghasia
M., Pradhan S., Zelko H. & Pietrobon R.
(2010) What leads Indians to participate
in clinical trials? A meta-analysis of
qualitative studies. PLoS ONE 5, e10730.
Socialstyrelsen T.N.B.O.H.a.W. (2011)
Quality and Efficiency in Swedish Cancer
Care – Regional comparisons 2011 (ed
2009:11, S.).
Streiner D.L. & Norman G.R. (2008) Health
Measurement Scales. Oxford University
Press, New York, NY, USA.
Stryker J.E., Wray R.J., Emmons K.M.,
Winer E. & Demetri G. (2006) Under-
standing the decisions of cancer clinical
trial participants to enter research
studies: factors associated with informed
consent, patient satisfaction, and deci-
sional regret. Patient Education and
Counseling 63, 104–109.
Verheggen F.W., Nieman F.H., Reerink E. &
Kok G.J. (1998) Patient satisfaction
with clinical trial participation. Interna-
tional Journal for Quality in Health
Care: Journal of the International Society
for Quality in Health Care/ISQua 10,
319–330.
Main motives behind participation in clinical cancer trials
© 2014 John Wiley & Sons Ltd 9
