MC Kinney December 2021 CJON

Clinical Trial
Participation
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A pilot study of patient-identified barriers

Mishellene McKinney, MHA, RN, OCN®, Rose Bell, PhD, AOCNP®, ARNP-C, Cindy Samborski, MSN, MHA, RN, CCRC, Kristopher Attwood, PhD,
Grace Dean, PhD, RN, Katherine Eakle, PharmD, Wei Yu, PhD, and Stephen B. Edge, MD, FACS, FASCO
BACKGROUND: Clinical trial enrollment in the

United States is lacking, particularly among older
adult and ethnic and racial minority populations.
OBJECTIVES: The aim of the current study was

to identify patient-related barriers to clinical trial
participation using a mixed-methods patient survey
and to offer insights to develop evidence-based
implementation strategies to address these barriers.
METHODS: A retrospective survey was conducted

of patients who were not interested in participat-
ing in a clinical trial to quantify the reasons these
patients chose not to participate. Directed qualita-
tive content analysis was used to identify themes
P PROGRESS IN CANCER CARE REQUIRES ONGOING CLINICAL TRIALS. Only 3%–5% of
adult cancer treatment in the United States is provided within a clinical trial
(Hallquist Viale, 2016). Little progress has been made in the past decade in
terms of improving clinical trial enrollment in the United States, particularly
for older adults and those in ethnic and racial minority groups (Sedrak et al.,
2021). Barriers to cancer trial enrollment have been explored and reported
extensively in the literature. The most common obstacles have been broadly
categorized as structural, clinical, and physician or patient related (Lara et
al., 2001; Mills et al., 2006; Nipp et al., 2019; Sedrak et al., 2021; Unger et
al., 2019). Hillyer et al. (2020) reported that there remains a wide dispar-
ity in provider versus patient attitudes and beliefs regarding clinical trials.
Oncology nurses play a pivotal role in identifying and addressing patient con-
cerns about clinical trials.
In a systematic review and meta-analysis, structural and clinical barriers
accounted for more than 77% of patients not enrolling in a clinical trial (Unger
that emerged from the write-in responses. et al., 2019). Structural barriers include the absence of an available trial at an
institution and other factors, such as limited clinical research staff support.
FINDINGS: The greatest patient-reported barriers The institution may not offer clinical trials at all or may not offer a trial that is
were misperceptions about placebos, a desire appropriate for the patient’s cancer type or stage. More than 85% of patients in
to not feel like a human guinea pig, uncertainty the United States receive cancer care in a community setting, where there are
surrounding clinical trial treatment effectiveness fewer opportunities for trial participation than at an urban academic center
compared to standard care, and concerns about (American Cancer Society Cancer Action Network, 2018).
additional appointments or tests. Oncology Clinical barriers include restrictive clinical trial eligibility criteria. Trial
nurses can address patient enrollment barriers by eligibility criteria help to ensure a defined population to address the research
providing targeted education and participating in question and protect the safety of trial participants because of the poten-
the informed consent process. tial impact the study may have on patients with more serious health issues.
Despite recommendations from the American Society of Clinical Oncology
KEYWORDS to update trial eligibility to be more representative of the health of patients
clinical trial; enrollment; patient-related with cancer, stringent eligibility criteria persist (Kim et al., 2017). Ineligibility
barriers; mixed-methods survey rates in the United States are between 18.5% and 25.4% (Unger et al., 2019). In
particular, the expansion of personalized medicine (i.e., the use of patients’
DIGITAL OBJECT IDENTIFIER genetic or other biomarker information to make treatment decisions) has
10.1188/21.CJON.647-654 led to an increase in biomarker-specific trials that limit eligibility to a small
group of patients (Janiaud et al., 2019).
CJON.ONS.ORG DECEMBER 2021, VOL. 25, NO. 6 CLINICAL JOURNAL OF ONCOLOGY NURSING 647
CLINICAL TRIAL PARTICIPATION
Physicians play a critical role in presenting trials to patients

and helping them to understand the role of a clinical trial in
their treatment. When eligible patients are presented with a
“Little progress has
trial by their physician, they agree to participate more than 50%
of the time (Unger et al., 2019). Physicians may decide not to
been made in terms
discuss trials with patients because of time constraints or treat-
ment preference. They may also be unaware of trial options or
of improving clinical
have concerns about the complex nature of protocols (Mills et
al., 2006). This may be an area where oncology nurses can help
trial enrollment in the
physicians through assisting in identifying trial candidates and

educating patients about the value of clinical trials.
United States.”
Patient-related barriers can include personal factors and
beliefs that affect patient willingness to participate. Other factors
identified include concerns of a negative impact on their relation- to ascertain whether basic eligibility is met. Physicians introduce
ship with their physician (Mills et al., 2006), patient and family the standard of care and the clinical trial to the patient as treat-
dynamics (Hillyer et al., 2020), fear of placebo, loss of control, ment options. If the patient chooses the clinical trial, the clinical
time required to participate, and fear of side effects (Hillyer et al., research coordinator reviews the research study consent in depth
2020; Mills et al., 2006; Nielsen & Berthelsen, 2019; Nipp et al., to ensure that the patient understands the trial. Once consent
2019; Sedrak et al., 2021). is obtained, study-related tests are initiated to determine final
The aims of this study were to (a) identify patient-related eligibility.
barriers to clinical trial participation and (b) present oncology
nurses with evidence-based strategies to address these barriers. Patient Eligibility and Recruitment
The study population consisted of adult English- and Spanish-
Methods speaking patients receiving a clinical oncology pathway
Sample and Setting recommendation for a cancer type and circumstance (e.g., adju-
This study was a retrospective mixed-methods analysis of patients vant therapy, metastatic or recurrent cancer) where a clinical trial
not interested in participating in a clinical trial. Quantitative anal- was presented to the provider for consideration. Eligible patients
ysis was used for closed-ended survey questions, and directed were identified using data from the clinical oncology pathway.
qualitative content analysis was used to identify themes that The data were filtered to identify patients who declined to partic-
emerged from the write-in responses. The survey was conducted ipate and who had a solid tumor cancer: breast, gastrointestinal,
from January 24 to June 30, 2019. The Roswell Park Institutional genitourinary, gynecologic, head and neck, and thoracic cancers,
Review Board approved this study, and participants signed a writ- and melanoma.
ten consent form to participate. If the provider documented in the clinical oncology pathway
Data from the point-of-care clinical oncology pathway system that the patient was not interested in any trial or this trial, and if
at the Roswell Park Comprehensive Cancer Center in Buffalo, the patient met the other basic eligibility criteria for study par-
New York, were leveraged to help identify patients who were ticipation, a research staff member contacted the patient to join
eligible for trials based on cancer type, staging, and relevant bio- the study. The researcher also verbally confirmed with patients
markers and other clinical characteristics. In the clinical oncology that they were not interested in participating in a trial. Eligible
pathway, the medical oncology provider shares information on patients were consented for this study, and a hard copy survey
the patient’s cancer type, stage, biomarkers, and clinical situation. was given to the patient to complete and collected immediately.
If a clinical trial at the center is open for accrual and matches the
basic clinical situation, it is presented to the provider as the first Data Collection
treatment choice. The provider must then either select a trial or The mixed-methods survey was based on a questionnaire used
select from a list of reasons why a trial was not selected (patient in a similar study at the Royal Marsden Hospital in London,
eligibility, provider preference, insurance or cost, patient prefer- England (Moorcraft et al., 2016). The questionnaire, licensed
ence, other reason). If the provider selects the trial, the clinical under a Creative Commons Attribution 4.0 International License
oncology pathway immediately sends an automatic message with unrestricted permissions, was developed based on a review
to the clinical research coordinator to complete full eligibility of the literature and the authors’ experiences of trial recruit-
screening for that trial. ment. The modified mixed-methods survey used for this study
Clinical research coordinators and physicians at Roswell Park was expanded to include open-ended write-in responses to the
Comprehensive Cancer Center review a patient’s medical history following questions for richer qualitative analysis:
648 CLINICAL JOURNAL OF ONCOLOGY NURSING DECEMBER 2021, VOL. 25, NO. 6 CJON.ONS.ORG
ɐ How do you view being asked to participate in cancer research? metastatic solid tumors. Most participants were female (n = 14)
Please elaborate on this question—why? and non-Hispanic White (n = 17) and reported their education
ɐ Please explain the reasons that you decided not to enroll level as college (n = 11). The mean age of participants was 64 years
in the clinical trial; underline or circle the most important (range = 41–69 years).
reason to you. The majority of participants had not previously participated
ɐ Please let us know any changes you would have made to make in a clinical trial (n = 17). Travel time to get to the cancer center
you more interested in participating in the clinical trial. varied; 11 participants stated it took more than 30 minutes to
ɐ Please explain what a clinical trial means to you, in your own reach the cancer center, and 6 said it took one to two hours.
words.
The survey includes Likert-type (n = 6), multiple-choice (n = TABLE 1.

19), and open-ended responses (n = 3), as well as demographic SAMPLE CHARACTERISTICS (N = 21)
questions. An oncology and nursing research team reviewed
the modified version for face and content validity. The open- CHARACTERISTIC n
ended survey responses and their analysis were intended to be
Education
an adjunct to the primary survey research, with the intention of
enhancing the analysis of closed-ended survey responses. Survey High school 7
study data were collected and managed using REDCap, a secure,
Some college or no degree 3
web-based software platform designed to support data capture
for research studies (Harris et al., 2019). College 11
Metastasis
Mixed-Methods Analysis
A mixed-methods approach was used to analyze the survey data. Yes 17
Statistical analysis was performed to determine the mean and range
No 4
for continuous responses, and counts and percentages for categor-
ical responses. Directed qualitative content analysis was used to Race
identify concepts and themes that emerged from the open-ended
Non-Hispanic White 17
responses. The directed qualitative content analysis approach is
generally used to describe a phenomenon that would benefit from African American 2
further description (Assarroudi et al., 2018) and was used here to
American Indian or Alaska Native 1
probe patients’ perceptions of participating in a clinical trial. The
primary author and research assistant coded the data, and the expert Other or not specified 1
panel reached consensus about the final themes that emerged.
Sex
Results Female 14
Trials Presented for Prescreening
Male 7
During the study time period, there were 272 cases of trials offered
to 164 unique patients that were categorized in the clinical oncol- Tumor type
ogy pathway as the patient not being interested in clinical trial
Breast 4
participation. Of these patients, 23 were deceased before being
approached about study participation, and 75 were determined Colorectal 4
to be ineligible because the patient did not recall being offered
Gastroesophageal 3
clinical trial participation when approached by the researcher, or
the patient was hospitalized or too ill to approach. In addition, Non-small cell lung 3
36 patients did not have a scheduled appointment at the cancer
Pancreatic 3
center within the enrollment window or were missed. Of the 30
patients who were approached to take the survey, 9 declined and Ovarian 2
21 completed the survey, for a 70% participation rate.
Prostate 1
Quantitative Survey Data Uterine 1

Sample characteristics can be found in Table 1. Most participants
(n = 17) had a clinical oncology pathway treatment decision for
Most participants (n = 15) had someone else drive them to the In write-in responses, there was no correlation between the word
cancer center (e.g., friend, family member, public transportation “placebo” appearing in the trial name and participants voicing
service). their concerns about receiving a placebo. Figure 1 summarizes the
Participants reported receiving the most information about participant topics, themes, and quotes.
clinical trials from their oncologist (n = 9) or the clinical research
coordinator (n = 9). The family and friends that participants Discussion
reported discussing treatment with most were spouses (n = 10) Participants who declined clinical trial participation primarily cited
and their children (n = 9). concerns related to the ambiguity of effectiveness versus standard
Most participants surveyed (n = 16) saw being asked to par- of care, the time required for participation in a trial, and lack of
ticipate in cancer research as positive. No participants felt that control of treatment choice. Findings from the current study sup-
it was negative, with the remainder of respondents (n = 5) seeing port those in the literature regarding patient barriers to enrollment
it as neither positive nor negative. Most (n = 19) responded pos- (American Cancer Society Cancer Action Network, 2018; Dias et al.,
itively (agree or strongly agree) to the following statement: “I 2016; Hillyer et al., 2020; Lara et al., 2001; Manne et al., 2015; Mills
believe clinical trials associated with cancer research will help et al., 2006). The survey data suggest that designers of clinical trials
doctors better understand and treat cancer.” A few (n = 2) were should consider factors affecting the patient’s burden of participa-
concerned about the use and storage of blood and tissue samples tion. This has been examined extensively in the literature (Manne et
for research, and one participant reported being concerned about al., 2015; Mills et al., 2006; Naidoo et al., 2020; Nielsen & Berthelsen,
incurring additional costs because of clinical trial participation. 2019; Sedrak et al., 2021). Making the frequency of clinic visits and
Overall, participants reported that the amount of information time commitment equivalent to standard-of-care treatment should
provided about the clinical trial and the time spent discussing the be considered a goal when designing trials. Findings from the cur-
clinical trial were adequate (see Table 2). The most frequently rent study support that time can be a significant burden.
reported barriers in the multiple-choice response section were Although cost was not reported as a barrier by most partic-
concerns about receiving a placebo (n = 11) and not wanting to ipants, indirect costs, such as additional requirements for time
feel like a human guinea pig (n = 9). away from work or family care (Nusbaum et al., 2017), could result
in a financial burden to patients (Nipp et al., 2019; Winkfield et
Qualitative Survey Data al., 2018).
When asked about changes that would make them more inter- Wright et al. (2004) showed that perceived personal benefit
ested in participating in a clinical trial, 10 participants wanted was the most significant patient-related predictor of clinical trial
more supporting evidence for the trial, indicating a perceived enrollment. The current authors’ analysis of write-in responses
risk about the quality of trial outcomes compared to standard- expands on this by providing additional perspective on the par-
of-care outcomes. Response themes for the question concerning adoxical concern about the risk of participation because, as one
reasons that participants decided not to enroll in a clinical trial participant stated, it is “unknown if it would be better than stan-
indicated concerns about additional appointments or tests and dard of care—too risky.”
the perceived risk of participating in a clinical trial versus receiv- Participant comments on the study survey indicated confu-
ing the standard of care, including concerns related to receiving sion about the availability of efficacy data for the trial treatment
a placebo and the uncertainty of the effectiveness of the treat- offered. Some participants did not appear to understand that
ment. When asked to explain what a clinical trial was in their own efficacy data are not yet available for most phases of a clinical
words, three participant responses included the word “placebo.” trial. For example, one participant stated that they would be
TABLE 2.
SURVEY RESPONSES: CLINICAL TRIAL COMMUNICATION (N = 21)
QUESTION YES NO
Did you feel you were given enough time to consider whether you wished to participate in the trial? 20 1
Were you given the opportunity to ask questions before making your decision? 20 1
Would you have liked more time to ask questions? 3 18
Did you feel pressure to participate in the trial that was offered? 2 19
more willing to participate in a trial in the future by “knowing the barriers. Topics address many of the barriers identified in the cur-
results of testing in the past.” The provision of efficacy data to the rent study, including the following questions:
patient depends on the phase of the trial offered. ɐ What is a placebo?
Patient-related barriers can be addressed through com- ɐ Will taking part in a clinical trial help me?
munication and education. Implementation of patient-level ɐ Are there ways to deal with transportation and financial
interventions, such as PRE-ACT (Preparatory Education About issues?
Clinical Trials) (Meropol et al., 2016), has been shown to be useful Patients can access this free series of educational videos on
in a prospective multisite randomized clinical trial and should be Cancer.Net, a patient information website managed by the
considered for broad dissemination. The study by Meropol et American Society of Clinical Oncology (n.d.).
al. (2016) is the largest randomized controlled trial to date that Work that addresses nursing interventions includes a National
has looked at an intervention using a series of patient-facing Institutes of Health–funded study, Oncology Nurse IMPACT:
educational videos specifically designed to address patient-level Improving Communication with Patients about Clinical Trial,
FIGURE 1.
SELECTED WRITE-IN SURVEY RESPONSES
HOW DO YOU VIEW BEING ASKED TO PARTICIPATE IN CANCER PLEASE LET US KNOW ANY CHANGES YOU WOULD HAVE MADE TO
RESEARCH? MAKE YOU MORE INTERESTED IN PARTICIPATING IN THE
Positive CLINICAL TRIAL.
ɔ “Anything can help—my understanding is they don’t know enough about Evidence of positive outcomes
stomach cancer, and there is a lot of money involved to find something to ɔ “That it would have a better outcome [than the standard of care]”
help it.” ɔ “Knowing the results of testing in the past”
ɔ “Help future patients” ɔ “Receiving more information about the trial”
ɔ “Possibly better outcome” Travel and delays in care

ɔ “Willing to try anything, as long as it is doable” ɔ “Less of a wait for enrollment and treatment”
Not positive or negative ɔ “Not having to travel for more appointments”
ɔ “I was concerned why I was chosen.” Would not consider/viewed as last resort
ɔ “It builds hope.” ɔ “If no other treatment”
PLEASE EXPLAIN THE REASONS THAT YOU DECIDED NOT TO ɔ “Nothing”
ENROLL IN THE CLINICAL TRIAL. ɔ “Not interested”
Additional time or requirements PLEASE EXPLAIN WHAT A CLINICAL TRIAL MEANS TO YOU, IN YOUR
ɔ “Too much time to travel, wife’s health issues” OWN WORDS.
ɔ “Was not ready for a regimented program with no flexibility” Cure or efficacy
ɔ “The time involved—I babysit my grandchildren.” ɔ “A study to see if there is room for improvement in how Roswell [Park Com-
Delay in care prehensive Cancer Center] handles future cases”

ɔ “Could not participate because it required time to wait to enroll; [it] could ɔ “To help [doctors] know how to treat patients with cancer”
have taken up to two weeks to participate.” ɔ “Trying new treatments and medicines to get better results and advance-
ɔ “Didn’t want to delay treatment” ments”

Distrust of research ɔ “Experimental treatments to determine specific efficacy”
ɔ “No time for the games” Placebo

ɔ “Guinea pig feelings” ɔ “Study where conditions are identical for participants, except 1/2 gets
ɔ “I just don’t want to be tested on.” placebo and 1/2 gets trial drug”
Perceived risk in efficacy of treatment ɔ “An extra drug given to 50%, and 50% get a placebo”
ɔ “Unknown if it would be better than standard of care—too risky” Testing

ɔ “I chose the best care option that was presented.” ɔ “Try a new procedure or a pill or food that could or couldn’t help myself or
Placebo others”
ɔ “I wanted not to be in the placebo part of the trial; I guess I wanted the added ɔ “Being used as a guinea pig”
benefit without the chance of not getting the extra benefits.” ɔ “Testing different [medications] for the type of cancer you have”
ɔ “Not wanting placebo” ɔ “Test of a new drug or treatment”
IMPLICATIONS FOR PRACTICE

ɔ Proactively support and address the uncertainty that patients
feel about trial effectiveness when approached to participate in a
clinical trial.
testing the value of a tailored video-based educational interven- ɔ Implement evidence-based, multifaceted interventions that include
tion designed to increase oncology nurse intention to discuss education programs for patients and nurses.
clinical trials with patients. This study was built on work by Flocke ɔ Include the entire healthcare team in helping patients understand
et al. (2019) that measured the attitudes, subjective norms, and the role and value of clinical trials.
perceived behavioral control using survey data from more than
1,900 Oncology Nursing Society members.
A potential solution to the barrier of patient knowledge deficit Nurses should maintain proficiency through continuing edu-
suggested by Nipp et al. (2019) is the integration of patient cation related to the design and importance of clinical trials.
navigators into the clinical trial accrual process. Navigation Nurses can also benefit from watching the PRE-ACT patient
has been shown to improve accrual to clinical trials in multiple video series to enhance their knowledge; the videos provide
studies, and particularly to increase participation among African an example of how to present complex concepts in a concise,
American individuals (Fouad et al., 2016; Winkfield et al., 2018). understandable way to patients (American Society of Clinical
In addition, the Education Network to Advance Cancer Clinical Oncology, n.d.). Nurses can address patient concerns about the
Trials program recommends that documented prescreening of all availability of efficacy data for the trial treatment by reassuring
patients for clinical trial eligibility and the inclusion of clinical patients that although they cannot predict whether a trial will be
trial navigators be mandated (Nipp et al., 2019). more beneficial than the standard of care, trials are based on sci-
entific evidence that the new treatment has promise (American
Limitations Cancer Society Cancer Action Network, 2018).
The current study was conducted using a convenience sample at Nurses may also be involved in providing informed consent.
a single cancer center. Methodologic limitations included a small As noted in the Oncology Nursing Society’s (2016) Oncology
sample size (n = 21) that was 7% of the eligible patient population Clinical Trial Nurse Competencies, nurses play a role in providing
(N = 272). In addition, the study ratio of females to males was leadership and ensuring patient comprehension and safety during
2:1. Because of the small sample size, there were few non-White the informed consent process (Ness & Royce, 2017). The use of
participants. The survey, although used previously in a similar evidence-based nursing interventions, such as the teach-back
research context, was not a validated tool and was modified for method to verify patient understanding during informed consent
the practice setting. Therefore, findings from the study may not discussions, is recommended (Brega et al., 2015). A key compo-
be generalizable. nent of the teach-back method is putting the responsibility of
The use of the directed qualitative content analysis method patient understanding on the nurse.
to analyze the open-ended survey responses presents limitations. Studies such as that by Regan (2018) have demonstrated
The directed approach can lead to confirmation bias, meaning the effectiveness of the teach-back method, an evidence-based
that researchers are likely to find evidence that is supportive of a health literacy intervention, during informed consent. Nurses
particular hypothesis (Hsieh & Shannon, 2005). There is also the are provided with examples of teach-back scripts that can be
potential that contextual features that may have influenced par- used with patients in the informed consent process. Regan
ticipant responses were not recognized. To reduce the amount (2018) demonstrated that after receiving teach-back training,
of bias, study team members reviewed the data independently to nurses had high research knowledge scores and demonstrated
confirm trustworthiness of the responses. statistically significant improvement in post-test conviction
and confidence.
Implications for Nursing
When addressing educational barriers, the entire healthcare team Conclusion
should help patients understand the purpose of clinical trials and The results of the current study can be used by all stakeholders
the potential value of trial participation. Nurses have many roles to develop multifaceted interventions that include evidence-based
in their facilities and often have extended contact with patients; education programs for nurses and patients, as well as accom-
therefore, they are in a unique position to support patients in their modations to support patients in minimizing the time and effort
decision-making regarding clinical trial participation. Nurses can required to participate in a clinical trial. In addition, these findings
provide targeted education, address patient-identified concerns, demonstrate key gaps in patient understanding of clinical trials;
and participate in the informed consent process. Understanding they also support the need to conduct more extensive implemen-
and assimilating themes identified in this study may enhance tation studies on the feasibility and acceptability of evidence-based
nurses’ ability to identify, teach, and proactively discuss terms nursing interventions that have been shown to help address
such as “placebo” and the idea of receiving “extra treatment,” as patient-reported concerns about enrolling in clinical trials. Given
well as help patients explore concerns about the effectiveness of their central role in oncology care, nurses should be considered
trial treatments. integral members of the clinical research education program.
Mishellene McKinney, MHA, RN, OCN®, was, at the time of this writing, the director Fouad, M.N., Acemgil, A., Bae, S., Forero, A., Lisovicz, N., Martin, M.Y., . . . Vickers, S.M. (2016).
of clinical pathways and implementation science at Roswell Park Comprehensive Patient navigation as a model to increase participation of African Americans in cancer clinical
Cancer Center in Buffalo, NY; Rose Bell, PhD, AOCNP®, ARNP-C, is a clinical oncol- trials. Journal of Oncology Practice, 12(6), 556–563. https://doi.org/10.1200/jop.2015.008946
ogy nurse practitioner at Roswell Park Care Network in Buffalo, NY, and an associate Hallquist Viale, P. (2016). Participation in cancer clinical trials: Researching the causes of low
professor in the Department of Nursing at Daemen College in Amherst, NY; Cindy accrual. Journal of the Advanced Practitioner in Oncology, 7(2), 143–144. https://doi.org/
Samborski, MSN, MHA, RN, CCRC, is a senior clinical research coordinator and 10.6004/jadpro.2016.7.2.1
clinical research educator, and Kristopher Attwood, PhD, is an assistant professor Harris, P.A., Taylor, R., Minor, B.L., Elliott, V., Fernandez, M., O’Neal, L., . . . Duda, S.N. (2019). The
of oncology, biostatistics, and bioinformatics, both at Roswell Park Comprehensive REDCap consortium: Building an international community of software platform partners.
Cancer Center; Grace Dean, PhD, RN, is an associate professor in the School of Journal of Biomedical Informatics, 95, 103208. https://doi.org/10.1016/j.jbi.2019.103208
Nursing at the University at Buffalo in New York; Katherine Eakle, PharmD, is the Hillyer, G.C., Beauchemin, M., Hershman, D.L., Kelsen, M., Brogan, F.L., Sandoval, R., . . .
medical science director, and Wei Yu, PhD, is the head of oncology biostatistics and Schwartz, G.K. (2020). Discordant attitudes and beliefs about cancer clinical trial participa-
a data and statistical sciences leader, both at Genentech in South San Francisco, CA; tion between physicians, research staff, and cancer patients. Clinical Trials, 17(2), 184–194.
and Stephen B. Edge, MD, FACS, FASCO, is a professor of oncology and the vice https://doi.org/10.1177/1740774520901514
president of system quality and outcomes at Roswell Park Comprehensive Cancer Hsieh, H.-F., & Shannon, S.E. (2005). Three approaches to qualitative content analysis. Qualita-
Center. McKinney can be reached at mishellene.x.mckinney@kp.org, with copy to tive Health Research, 15(9), 1277–1288. https://doi.org/10.1177/1049732305276687
CJONEditor@ons.org. (Submitted February 2021. Accepted July 12, 2021.)
The authors gratefully acknowledge Nessa Stefaniak, MA, for data collection and PROFESSIONAL DEVELOPMENT ACTIVITY
research coordination; Monica Murphy, BSMT, for analytics support, and Lu Liu, EARN 1 CONTACT HOUR
PhD, for demographic data, as well as Joanne Abbotoy, MSN, RN, and Laurie
Musial, PhD, MSN, RN, who both provided guidance with the protocol formation ONS members can earn free nursing continuing professional development
and study design. (NCPD) for reading this article and completing an evaluation online. To
do so, visit cjon.ons.org/ncpd to link to this article and then access its
The authors take full responsibility for this content. This work was supported evaluation link after logging in.
by Genentech and a grant (P30CA016056) from the National Cancer Institute
involving the use of Roswell Park Comprehensive Cancer Center’s Pathology Certified nurses can claim no more than 1 total ILNA point for this
Network, Genomic, and Clinical Data Network shared resources. The article has program. Up to 1 ILNA point may be applied to Oncology Nursing Practice
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MC Kinney December 2021 CJON

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Clinical Trial

A pilot study of patient-identified barriers

BACKGROUND: Clinical trial enrollment in the

OBJECTIVES: The aim of the current study was

METHODS: A retrospective survey was conducted

Physicians play a critical role in presenting trials to patients

physicians through assisting in identifying trial candidates and

The survey includes Likert-type (n = 6), multiple-choice (n = TABLE 1.

Quantitative Survey Data Uterine 1

Would you have liked more time to ask questions? 3 18

help it.” ɔ “Knowing the results of testing in the past”

ɔ “Help future patients” ɔ “Receiving more information about the trial”

ɔ “Possibly better outcome” Travel and delays in care

Not positive or negative ɔ “Not having to travel for more appointments”

PLEASE EXPLAIN THE REASONS THAT YOU DECIDED NOT TO ɔ “Nothing”

ENROLL IN THE CLINICAL TRIAL. ɔ “Not interested”

Delay in care prehensive Cancer Center] handles future cases”

ɔ “Didn’t want to delay treatment” ments”

ɔ “No time for the games” Placebo

ɔ “Unknown if it would be better than standard of care—too risky” Testing

ɔ “Not wanting placebo” ɔ “Test of a new drug or treatment”

IMPLICATIONS FOR PRACTICE

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