Preparing Patients for the
Oncology Referral: The Role
of the Primary Care
Provider in Cancer Clinical
Trials
© 2014
2011 ENACCT Inc. All rights reserved. 1
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All uses of these training materials are subject to the
copyright and trademark notices contained in the
Training Materials and the Terms and Conditions
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ENACCT’s Web site, www.enacct.org.
© 2014
2011 ENACCT Inc. All rights reserved. 2
Continuing Education Credit
Physicians:
This course was previously approved for continuing
education credit for physicians. No credit is
currently offered.
To pursue credit approvals for course content, please
contact a local continuing medical education
provider in your community
© 2014
2011 ENACCT Inc. All rights reserved. 3
Objectives
Clarify common misconceptions among primary care
providers about cancer clinical trials
Reflect on your critical role, being the first point of
contact for patient access and participation in
clinical trials
Describe practical strategies referring physicians can
take to effectively prepare patients for discussions
with their oncologist about cancer clinical trials
© 2014
2011 ENACCT Inc. All rights reserved. 4
Did You Know…?
Only 2% of primary care providers routinely
discuss oncology clinical trials with their
patients.
A physician’s recommendation is often the
primary factor influencing patients’ decisions to
enroll in a trial.
A 2004 article by Sherwood and colleagues
indicated that provider attendance at cancer
clinical trial education sessions consistently
predicted referral.
Crosson, K., Eisner, E., Brown, C., & Ter Maat, J. (2001). Primary care physicians’ attitudes, knowledge, and practices related to
cancer clinical trials. J Canc Educ,16(4), 188-192; Comis, R.L, Miller J.D, Colaizzi D, Kimmel L.G. Physician-Related Factors
Involved in Patient Decisions to Enroll onto Cancer Clinical Trials. Journal of Oncology Practice, Vol 5, Issue 2, 2009 pp 50-56;
Sherwood P., Give B., Scholnik A, Given C. J Cancer Education 2004; 19:58-65 To Refer or Not to Refer: Factors that Affect Primary
Care Provider Referral of Patients with Cancer to Clinical Treatment Trials
© 2011 ENACCT Inc. All rights reserved. 5
Cancer Clinical Trials:
Importance for Primary
Care Providers
© 2014
2011 ENACCT Inc. All rights reserved. 6
Quotes to Consider
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2011 ENACCT Inc. All rights reserved. 7
Quotes to Consider
“I think the primary care provider can be
a resource for general conversation about
clinical trials rather than referring a
patient for a particular clinical trial.”
Larissa Neklyudov, MD, General Internist
“Oftentimes [patients] return back to our
office because they have other concurrent
medical problems, but we’ll have the
opportunity to kind of reinforce or support
their decision to enter a clinical trial….”
Anthony T. McCormack, MD, Geriatric Medicine
© 2014
2011 ENACCT Inc. All rights reserved. 8
What Are Cancer Clinical Trials?
© 2014
2011 ENACCT Inc. All rights reserved. 9
Cancer Clinical Trials
Focus on developing new strategies for the prevention,
detection, and treatment of cancer and overall
improvement in the quality of life of…
People with cancer or
People at high risk for developing cancer
National Cancer Institute (2002a)
© 2014
2011 ENACCT Inc. All rights reserved. 10
Types of Cancer Clinical Trials
Treatment
Prevention
Screening and
Early Detection
Diagnostic
Genetics
Quality-of-Life/Supportive Care
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2011 ENACCT Inc. All rights reserved. 11
Participation in Clinical Trials
About 20% of cancer patients are medically eligible for
a clinical trial 1; however…
Trial participation among adult cancer patients
remains low, at about 2.5% to 3%.2‒4
This rate is even lower among people of color and
the medically underserved.5‒7
1 U.S.
Department of Health and Human Services (2004); 2 Sateren et al. (2002); 3 Christian and Trimble (2003); 4 National Cancer Institute (2002b);
(2000); 6 Murthy, Krumholz, and Gross (2004); 7 Stewart et al. (2007)
5 Brawley
© 2014
2011 ENACCT Inc. All rights reserved. 12
Cancer Clinical Trials:
Myths and Facts
© 2014
2011 ENACCT Inc. All rights reserved. 13
Myth 1
Clinical trials have nothing
to do with my day-to-day
medical practice
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2011 ENACCT Inc. All rights reserved. 14
FACT: Yesterday’s Trials Are
Today’s Improved Treatments
Standard treatment options today are based on the
results of past clinical trials, resulting in…
Changes in clinical practice
Decreases in morbidity and mortality
Creation of more-effective treatment options
Improved quality of life for people diagnosed with
cancer
© 2014
2011 ENACCT Inc. All rights reserved. 15
Improved Treatment Has Had a
Large Impact on Survival Rates
* Five-year relative survival rates based on follow-up of patients through 2002.
** Recent changes in classification of ovarian cancer have affected 1995–2001 survival rates
SEER Program, 1975–2002, Division of Cancer Control and Population Sciences, National Cancer Institute (2005)
© 2014
2011 ENACCT Inc. All rights reserved. 16
FACT
Most cancer patients
are interested in clinical
trials but are never told
about the opportunity.
Comis RL et al. A Quantitative Survey of Public Attitudes Towards Cancer Clinical Trials (2000),
http://www.cancertrialshelp.org/CTHpdf/308-9.pdf; Comis RL et al. J Clin Oncol (2003)
© 2014
2011 ENACCT Inc. All rights reserved. 17
Clinical Trials: Quality Care
Access to cancer clinical trials: an established standard
for the delivery of quality comprehensive cancer care
American College of Surgeons Commission on Cancer
© 2014
2011 ENACCT Inc. All rights reserved. 18
Clinical Trials: Quality Care
Lack of access to equal treatment may contribute to
treatment and outcome disparities, especially for the
medically underserved
Some have suggested that clinical trials participation
may be able to help reduce those disparities
Institute of Medicine. The Unequal Burden of Cancer: An Assessment of NIH Research and Programs for
Ethnic Minorities and the Medically Underserved (1999)
© 2014
2011 ENACCT Inc. All rights reserved. 19
Clinical Trials: Quality Care
Some studies have suggested that research
participation may be associated with improved
clinical outcomes
These data have led some to recommend trial
participation as a means to better treatment
Daugherty C et al. J Clin Oncol (1995); Joffe S, Weeks JC. J Natl Cancer Inst {2002); Yuval R et al. Arch Intern
Med (2000); Karjalainen S, Palva I. BMJ (1989); Davis S et al. Cancer (1985); Marubini E et al. Lancet. (1996);
National Comprehensive Cancer Network (2006); Lara PN et al. J Clin Oncol (2001)
© 2014
2011 ENACCT Inc. All rights reserved. 20
Myth 2
Primary care providers
have no role to play in
encouraging their
patients diagnosed
with cancer to consider
clinical trials as a
treatment option.
© 2014
2011 ENACCT Inc. All rights reserved. 21
FACT: Your Influence Is Key
Patients are willing to participate but rarely get
asked.
Oncologists are the ones who talk most to patients
about clinical trials, but it is important for primary
care providers to introduce the option because they
are your patients, before, during, and after their
cancer treatment.
© 2014
2011 ENACCT Inc. All rights reserved. 22
Patients Are Willing to Participate
and Need to Be Invited
Most patients would consider a clinical trial if their
doctors recommended they do so.1
All who are eligible are not offered the opportunity to
participate by their treating physician.
20% or fewer of all cancer patients are ever told
about the option of receiving treatment through a
clinical trial.2,3
People from minority groups are even less likely to
be offered participation.4,5
1 Harris
Interactive (2002); 2 Comis et al. (2000); 3 Comis et al. (2003); 4 Sateren et al (2002); 5 Simon and Du (2004)
© 2014
2011 ENACCT Inc. All rights reserved. 23
Myth 3
Clinical trials are only
for patients who have
run out of other
treatment options.
© 2014
2011 ENACCT Inc. All rights reserved. 24
FACT: A Part of High-Quality Cancer
Care for Individual Patients
High-quality treatment options are open to many
cancer patients, even for first-line treatment.
“The best management of any cancer patient is in a
clinical trial.” — NATIONAL COMPREHENSIVE CANCER
NETWORK Clinical Practice Guidelines in Oncology
“Therapies offered through cancer clinical trials
should ideally be considered the preferred
treatment choice for physicians and patients….”
— INSTITUTE OF MEDICINE
Braunholtz DA, Edwards SJL, Lilford RJ. J Clin Epidemiol 2001;54:217–224; Peppercorn JM, Weeks JC, Cook EFC,
Joffe S. Lancet 2004;363:263–270
© 2014
2011 ENACCT Inc. All rights reserved. 25
Clinical Trial Phases at a Glance
Phase I
» Study questions: How should the treatment be given?
»
What dosage is safe?
Participants: People with no other treatment options
(n = 15 to 30)
Phase II
» Study question: Is the treatment effective?
» Participants: People with few treatment options (n < 100)
Phase III
» Study question: Is the new treatment (or new use of a
»
treatment) better than current practice?
Participants: Varies; many patients receive first-line
treatment through phase III trials (n = 100’s to 1,000’s)
© 2014
2011 ENACCT Inc. All rights reserved. 26
Benefits of Participation in Clinical Trials
Patients are closely monitored
Early access to investigational treatments
Participation in advancing medical knowledge
Active role in their own cancer care
© 2014
2011 ENACCT Inc. All rights reserved. 27
Risks of Participation in Clinical Trials
Investigational treatments may not be better than
standard care.
There may be unexpected side effects.
May not work for every patient.
The patient may bear additional costs.
© 2014
2011 ENACCT Inc. All rights reserved. 28
Costs and Other Trial
Participation Concerns
What is covered by health insurance and what is not?
» Medicare, Tricare, VA
What about eligibility?
» There are strict eligibility criteria
» May have a disproportionate effect on minority patients
© 2014
2011 ENACCT Inc. All rights reserved. 29
Myth 4
My patients will be treated
like “guinea pigs” if they
participate in a clinical
trial.
© 2014
2011 ENACCT Inc. All rights reserved. 30
Past Research Abuses
US Public Health Service Study
of Syphilis in the Negro Male
Jewish Chronic Disease
Hospital
Willowbrook Study
© 2014
2011 ENACCT Inc. All rights reserved. 31
Informed Consent Protects Patients’ Rights
Informed consent is a process. Patients are told about:
Purpose of the study
Procedures—what’s
going to happen and when
Risks and potential
benefits
Their individual rights
© 2014
2011 ENACCT Inc. All rights reserved. 32
FACT: Placebos Are Never Used in
Place of Appropriate Treatment
Patients never receive
a placebo instead of
appropriate treatment.
In phase III randomized
studies, patients receive
either standard care or
the new agent/approach being tested.
In earlier-phase studies, all patients receive the same
agent.
© 2014
2011 ENACCT Inc. All rights reserved. 33
Myth 5
Clinical trials are only
available at large
academic medical
centers in big cities.
© 2014
2011 ENACCT Inc. All rights reserved. 34
FACT: Cancer Clinical Trials Are Available
in Many Local Communities Too
Cancer clinical trials take place in many settings, not
just academic centers; many, over 60% occur at the
community level
Enhancing Cancer Treatment through Improved Understanding of the Critical Components, Economics
and Barriers of Cancer Clinical Trials. C-Change and Coalition of Cancer Cooperative Groups, 2006.
© 2014
2011 ENACCT Inc. All rights reserved. 35
Myth 6
Helping my newly diagnosed
patients (or patients being
referred for a diagnostic
work-up) gain access to
cancer clinical trials is going
to take too much time and
effort and should only occur
with the oncologist, not me.
© 2014
2011 ENACCT Inc. All rights reserved. 36
FACT: Cancer Treatment Options—
Part of What You Already Discuss
Many of you…
» play an active role in cancer patient management;
» believe that discussing cancer treatment options with your
patients is part of your role and responsibilities; and
» are already proactive in communicating with your patients
about cancer treatment options.
Mentioning cancer clinical trials in your discussions
with your patients complements what you already do.
Klabunde CN, Ambs A, Keating NL, et al. J Gen Intern Med 2009;24(9):1029–1036.
© 2014
2011 ENACCT Inc. All rights reserved. 37
What You Can Do: Mention Clinical
Trials as an Option for Treatment
First, discuss what your patient should expect from
diagnostic workup procedures in general.
Next, discuss what to expect from treatment options
in general.
Then, mention clinical trials as a viable
treatment option.
© 2014
2011 ENACCT Inc. All rights reserved. 38
One Quick Way to Say It
“I’m going to refer you to an
oncologist, who can talk about
your treatment options in
more detail. Ask him/her
about clinical trials, because
it’s a quality treatment option
for many patients.”
© 2014
2011 ENACCT Inc. All rights reserved. 39
Another Way to Say It
Larissa Neklyudov, MD
General Internist
© 2014
2011 ENACCT Inc. All rights reserved. 40
“[Providers] should be able to let the
patient know that clinical trials do
have the potential benefits on society
and other patients by enhancing the
knowledge and our understanding. A
clinical trial may help the patient
directly, but it may not. And that the
patient really needs to know about the
potential benefits and the potential
risks of any trial before they sign on
the dotted line.”
More You Can Do
Provide patient education
materials—either directly to
patients or made available in
waiting areas and exam room.
Refer patients only to oncologists
and surgeons who participate in
local clinical trials (or who will
refer patients to clinical trials).
To order:
1-800-4-CANCER
www.cancer.gov
© 2014 ENACCT Inc. All rights reserved. 41
Provider Discussion, Post Referral
Primary care provider–patient
communication beyond referral
“…It’s quite important for the primary care doctor to
realize that their role doesn’t end with the referral to
the medical oncologist.”
Jay Zatzkin, MD
Medical Oncologist
© 2014
2011 ENACCT Inc. All rights reserved. 42
“…The primary care doctor as a person with a longer
standing relationship with the patient than the
oncologist, whom they are just starting to see…are put
in a perfect position to either support or refute the
recommendation for clinical trials, whether they
know about the detail of the trial or not. If they
simply understand that clinical trials are a good thing
to recommend, it allows us to get their support.”
Patient Case Studies
© 2014
2011 ENACCT Inc. All rights reserved. 43
Consider Your Role in Cancer Care
Susan Jenkins, 56 years old, has
been sent for a routine
mammogram. Due to suspicious
findings, she is now being
referred to a surgeon, who
confirms her cancer diagnosis
and mentions clinical trials as a
treatment option. Susan has now
made a follow-up appointment
with you and is asking questions
about the pros and cons of her
treatment options.
© 2014
2011 ENACCT Inc. All rights reserved. 44
Patient Questions and Concerns:
How Would You Answer?
“The surgeon told me about a
clinical trial, but isn’t that only
for people who are really sick?
What do you think I should do?”
© 2014
2011 ENACCT Inc. All rights reserved. 45
Possible Responses
Clinical trials are not only for those with the most
advanced disease.
Many patients with many different types of cancer
receive their first treatment as part of a clinical trial.
Other patients participate in clinical trials after they
have already been treated with one or more standard
treatments.
© 2014 ENACCT Inc. All rights reserved. 46
Consider Your Role in Cancer Care
Maria Flores, 48, has chronic
myelogenous leukemia. She has been
seen by you for routine care since
completing cancer treatment 3 years
ago. Following an appointment with
you for routine care, at which she
presented with suspicious symptoms,
she returns to her oncologist for
further testing; it’s discovered that
she’s experiencing a recurrence. After
meeting with the oncologist, who
mentioned a clinical trial that she
may be eligible for, she comes back to
you to discuss her treatment options.
© 2014 ENACCT Inc. All rights reserved. 47
Patient Questions and Concerns:
How Would You Answer?
“My cancer doctor said there’s a
study I can join, but that I may
not get the new treatment being
tested. Why can’t I just get the
new treatment if it’s available?
It’s better than what’s already
out there, isn’t it?”
Cheung WY et al. J Clin Oncol 2009;27(15):2489–2495; Nekhlyudov L. J Clin Oncol 2009;27(15):2424–2426.
© 2014
2011 ENACCT Inc. All rights reserved. 48
Possible Responses
Patients are assigned to different groups in a trial,
and this selection is done by a computer. Neither
doctors nor patients can choose the group they are
assigned to.
This helps prevent study results from being
affected by a doctor's beliefs or choices—and helps
keep the groups as similar as possible and,
therefore, comparable.
If the new approach being tested in the trial was
already known to be better than standard care,
there would be no need for the study.
© 2014 ENACCT Inc. All rights reserved. 49
49
Consider Your Role in Cancer Care
Louis Green is a 62-year-old
African-American man with
Medicaid and blood in his urine
for “a few weeks.” A DRE
revealed an enlarged prostate.
The results of his blood work
indicate a PSA level of 12.0. Your
office staff contacts Mr. Green to
return to the office to discuss the
findings.
© 2014
2011 ENACCT Inc. All rights reserved. 50
Patient Questions and Concerns:
How Would You Answer?
“I don’t think I’d want to hear
anything about taking part in a
study for my treatment—I don’t
want to be a guinea pig in some
experiment.”
© 2014
2011 ENACCT Inc. All rights reserved. 51
Possible Responses
Patients who participate in clinical trials have both
rights and protections to make sure their privacy
and well-being are maintained.
One of the most important protections is informed
consent—a process does not end once the form is
signed.
Conduct of trials is overseen by local review
boards, and clinical findings of national studies are
monitored by Data Safety Monitoring Boards.
Participation is voluntary, and patients can leave a
study at any time.
© 2014 ENACCT Inc. All rights reserved. 52
Consider Your Critical Role
In ensuring your patients receive quality cancer care:
Refer to oncologists who participate in clinical trials.
Educate patients about the importance
of cancer clinical trials as an option for
first-line treatment.
Encourage patients to ask the oncologist
if there is a clinical trial that is right for him or her.
© 2014
2011 ENACCT Inc. All rights reserved. 53
Thank You
© 2014
2011 ENACCT Inc. All rights reserved. 54