cancer clinical research options for cancer survivors jeannette mendez, ba, ccrp cancer disparities...
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Cancer Clinical Research Options for Cancer Survivors
Jeannette Mendez, BA, CCRPCancer Disparities Research Coordinator
Mayo Clinic Arizona
What is cancer Clinical Research?
Cancer clinical studies are conducted by medical scientists to improve the care and treatment of cancer patients
Cancer clinical studies test new ways to: Diagnose and treat cancer in people Prevent or reduce disease or treatment side
effects Prevent or treat a recurrence of cancer Improve the comfort and quality
of life of people with cancer
Background
ACS estimated about 30,000 individuals in Arizona received a cancer diagnosis in 2010
An estimated 20% of all adult cancer patients are medically eligible for a cancer clinical trial
Trial participation in the US remains between 3-5% in the general population and 1% in minority groups.
Types of Studies
Screening
Prevention
Treatment
Quality of Life
Screening
Imaging
Laboratory
Genetics
•Test the best way to find cancer, especially in its early stages
Prevention
Test new methods, like medicines, vitamins, minerals, or other supplements that doctors think may lower the risk of a certain type of cancer
Two kinds of prevention clinical studies
Action studies (doing something) Find out whether actions people take, such as exercising more or quitting smoking, can prevent cancer.
Agent studies (taking something)Find out whether taking certain medicines, vitamins, minerals or food supplements (or a combination of them) can prevent cancer.
Treatment Studies
Test new treatments
new cancer drugs
new ways of doing surgery or radiation therapy
new combinations of treatments
new methods such as gene therapy
Are placebos used in cancer treatment clinical trials?
Placebos also known as “sugar pills” are rarely used in treatment trials! In fact, it is unethical to not treat a patient during their cancer journey!
Patients must minimally receive standard care.
Quality of Life
Look at ways to improve comfort and quality of life for cancer patients
Cancer control
Symptom management
Phases of a Study Objective: To establish a drug’s pharmacokinetic profile and
safety profile Protocol is less detailed to allow more design flexibility Phase I answers:
What is the correct dose? What are the side effects? How is the drug metabolized? Safety/tolerability?
First time in human subjects Pharmacokinetics / pharmacodynamics Open label, often single center Not always performed in the U.S.
Case Example #1
Native American, Female, metastatic breast cancer, Triple Negative, 3 prior chemo regimens, exhausted options at home institution
Would be eligible for studies that allow her indication and can range from phase 1 to 4.
Mayo had 5 options for her at one point excluding phase 1!
Case Example #2
Hispanic, Female, newly diagnosed breast cancer, indicated for masectomy with a mass larger than 2cm. Patient wants other options.
Patient eligible for neo-adjuvant study where she received chemo before surgery, and her tumor shrunk enough for her to have breast conservation surgery saving her from completely removing her breast.
Learning about clinical trials
Study DesignEligibilitySafetyCosts
Study Design
Each cancer clinical study has a written detailed design, called the protocol, that includes:
background of why the clinical study is needed the purpose of the study what drug or drugs are being tested, along with a
treatment and follow-up schedule safety measures to be followed throughout the
clinical study program
Eligibility
Clinical studies… are not only for people with the most advanced
disease can also be for people with newly diagnosed or very
limited disease are appropriate for different types of people,
depending on the purpose and phase of the study take into account age, gender, race, stage of disease,
other treatments used, and presence of any other illness
Safety
Each study is managed according to a strict set of rules intended to protect patients quality of care safety of participants
Researchers must explain the purpose, benefits, and risks of a clinical study before a patient gives consent must be in a language they understand they can ask questions if anything is unclear they can have a language interpreter if needed they may bring an advocate
Costs• Costs that are usually covered by the sponsor at no cost to the
patient:• research physician and nurse time• cost of the drug being studied
• Costs that may not be covered by private or public health insurance are those that a patient would have whether or not he / she was in a clinical trial:• hospitalizations• doctor visits• laboratory tests• drugs that are not part of the study design
If trials are successful, What gets in the way? Cancer patients may not have access to clinical studies
e.g., under-insured or have no insurance, worry about costMayo Clinic ADVOCATES-Economic hardship and Pharmacy
Assistance Programs may fear or distrust medical research
I don’t want to be a “guinea pig”Mayo Clinic EDUCATES-The Clinical Trial Process
may face practical obstacles: Transportation, meals, housing
Mayo Clinic provides SUPPORT through an ACS patient navigator.
If trials are successful, what gets in the way?
Cancer Patients … may lack health literacy may not want to ask their current doctor about
studies, or do not want to go against their doctor’s wishesMayo Clinic provides TRANSLATORS.
may be less likely to participate in clinical studies if they belong to an ethnic minority, or they are older / agedMayo Clinic employs CULTURALLY COMPETENT
staff.
Critical Barrier in Cancer Clinical Trials
Unaware of the option of participating in clinical trials. Research has consistently shown that most people are not aware that clinical trials could be an option for cancer treatment or prevention.
To achieve a balance in health literacy, clinical trial Awareness is vital.
A promise for the future
If we, as a population understand cancer research trials as a
therapy option, then we may extend the
life of those we love.
If we, as a population understand cancer research trials as a
therapy option, then we may extend the
life of those we love.
Participation in clinical trials: What gets in the way? Doctors might…
be unaware of available clinical studies believe that standard therapy is best be concerned about administrative burdens be unwilling to “lose control” of a patient’s care be concerned about how a patient will react to
the suggestion of a clinical study
Mayo Clinic educates members of the community on the need for minorities in cancer clinical trials.
A Mayo Research Experience
Diagnosis- Patient informed of treatment options. Research always included.
Consent-Patient is informed of study and asked if interested.
Screening- Staff makes sure patient is eligible. This is a safeguard.
Enrollment- Eligible patients enrolled.
A Mayo Research Experience
Active Treatment- Patient closely monitored by physician and research staff.Completion- Patient completes research therapyFollow Up- Patient is followed through study regulations.
#1 priority is the patient’s safety and well being!
Research Collaborations
Targeting increased minority enrollment in cancer trials, Mayo Clinic currently engages in research with:
-Maricopa Integrated Health Systems
-Mountain Park Health Center
-Phoenix Indian Medical Center
-Arizona State University.
Minorities in Research
Evidence of genetic variance in responses to cancer drugs!
Lack of minority representation in cancer research causes lack of true efficacy.
The solution to end disparity in medicine is to work together. Like the pieces of a jigsaw puzzle, each race’s genetic make-up is unique.
Advocating Cancer Trials
Participation in cancer research is key. Clinical Trial Education necessary for this to be achieved. Medicine is the glue that keeps us together and working towards a main goal. By full participation of all, we interlock these jigsaw puzzles and work to advance medicine as a team.
Research at your institution…
•
Risk Solutions
1.Communication barriers wit participants.
2.Barriers to acceptance within community health centers and physicians
3. Lack of patient participation
4. Lack of space availability to conduct studies.
5. Lack of sufficient finances for legal, IRB, or web maintenance services.
6. Lack of resources to complete projects within designated time frames.
1.Culturally competent and trained research teams
2.Guidance from Mayo Clinic resources to assist in promoting ideas.
3. Create events to foster trust.
4. Advocacy to further institutions such as schools and churches.
5. Seek economic hardship support from pharmacy assistance programs
6. Collaborate with current leading academic institutions for personnel support.
What can we do?
Know your community and it’s resources Create partnerships and establish relationships Provide education to the community, its leaders
and key stakeholders Listen to the needs of the community Be sensitive to the words you use to describe the
clinical trials process
“The needs of the patient come first”-Mayo Clinic
“One must not forget that recovery is brought about not by the physician, but by the sick man himself. He heals himself, by his own power, exactly as he walks by means of his own power, or eats, or thinks, breathes or sleeps” ~Georg Groddeck
Contact Info
Jeannette Mendez
Cancer Disparities Research Coordinator
(480)301-6478