The How, Where, and Why of Clinical Trials ERIN HAWKS, CCRC
Lost in the woods .
Standard of Care Treatment Nursing Staff Doctor Patient’s Personal Support Patient Integrated Care
Standard of Clinical Research Care Integrated Care Nursing Staff Treatment with the Doctor addition of Patient’s Personal Support Clinical Patient Research
Topics • Quick background of clinical research • What are the barriers that face cancer treatments? • Where do you find out information about clinical trials? • And why?
How many cancer patients participate in clinical trials? • 5% • 70% • 60% • 23.3% • 1.6%
How many cancer patients participate in clinical trials? • 5% , Less than 5% of Adult Cancer Patients participate in clinical trials with in the U.S.A. • 70%, Americans are willing or show interest in participating in clinical trials. • 60%, American Children with cancer are participating in clinical trials. • 23.3%, This is the latest data for Children in Idaho participating in clinical trials • 1.6%, This is the latest data for Adults in Idaho participating in clinical trials
Initial Barriers that Cancer Patient Face • First Patients need to have access to a cancer clinic. • Factors that Influence Patient’s Care: • Transportation • Travel costs • Access to insurance • Availability of child care
Structural Barriers • Now you are at the cancer clinic, does this clinic have access to clinical trials?
In December 2016, Joe Biden helped to established the CANCER MOONSHOT. This initiative aims to accelerate research efforts and break down barriers that are faced.
Which of these facilities have clinical trials available? • MD Anderson • MAYO • Huntsman • Saint Alphonsus • Great Falls Clinic
Which of these facilities have clinical trials available? • MD Anderson • MAYO • Huntsman THEY ALL HAVE CLINICAL TRIALS • Saint Alphonsus AVAILABLE • Great Falls Clinic
How do I access clinical trials?
National Cancer Institute (NCI) • NCI was established through the National Cancer Act of 1937, signed into law by President Franklin D. Roosevelt • NCORP (NCI Community Oncology Research Program), Created in 1983 by the National Cancer Institute (NCI) • NCORP currently has over 900 research facilities throughout the nation.
NCORP SITES Throughout THE NATION
NCORP SITES IN IDAHO AND MONTANA Idaho Clinics or Hospitals: Montana Clinics or Hospitals: • Benefis Healthcare - Sletten Cancer Institute- Great Falls • Kootenai Cancer Center- Post • Billings Clinic Cancer Center- Billings Falls & Sandpoint • Bozeman Deaconess Hospital- Bozeman • Kootenai Medical Center- • Community Hospital of Anaconda- Anaconda Coeur D'Alene • Community Medical Hospital- Missoula • Saint Alphonsus Cancer Care • Great Falls Clinic- Great Falls Center – Boise, Nampa, & • Kalispell Regional Medical Center- Kalispell Caldwell • Saint Peter's Community Hospital- Butte • Saint Luke's Mountain States • Saint Patrick Hospital - Community Hospital- Missoula Tumor Institute- Boise, • Saint James Community Hospital and Cancer Treatment Meridian, Nampa, Fruitland, Center- Butte and Twin Falls • Saint Vincent Frontier Cancer Center- Billings • Summit Cancer Center- Boise • Saint Vincent Healthcare- Billings
NCORP GROUPS IN IDAHO AND MONTANA Pacific Cancer Research Consortium Montana Cancer Consortium: www.MTcancer.org MT MT • Saint Patrick Hospital - Community Hospital- Missoula • Benefis Healthcare - Sletten Cancer Institute- Great Falls ID • Billings Clinic Cancer Center- Billings • Saint Luke's Mountain States Tumor Institute- Boise, • Bozeman Deaconess Hospital- Bozeman Meridian, Nampa, Fruitland, and Twin Falls • Community Hospital of Anaconda- Anaconda Colorado Cancer Research Program: www.CO- • Community Medical Hospital- Missoula cancerresearch.com • MT Great Falls Clinic- Great Falls • Saint James Community Hospital and Cancer Treatment • Kalispell Regional Medical Center- Kalispell Center- Butte • Saint Peter's Community Hospital- Butte • Saint Vincent Frontier Cancer Center- Billings ID • Saint Vincent Healthcare- Billings • Kootenai Cancer Center- Post Falls & Sandpoint Seattle Cancer Alliance: www.Seattlecca.org • Kootenai Medical Center- Coeur D'Alene ID • Saint Alphonsus Cancer Care Center – Boise, Nampa, & • Summit Cancer Center- Boise Caldwell
Searching for Clinical Trial • www.ClinicalTrials.gov • www.Cancer.gov/about-cancer/treatment/clinical-trials/search • www.MTcancer.org • www.CO-cancerresearch.com • www.Seattlecca.org • Contacting your local cancer clinic or hospital
Clinical Barriers • Even if trials are available at this clinic, patients may not be eligible. Why? • Protocol Eligibility has a narrow criteria- patients are excluded due to safety concerns. It is estimated that 18% of patients that meet the inclusion criteria will be excluded due to medical history, previous treatments, co-morbidity/ performance status (60%), or other factors.
Physician Attitudes • 87% of Oncologist in community cancer clinics feel that clinical trials provide high quality care and they feel that 83% of enrolled patient benefit from their participation. • A physician’s role is to guide the patients care in determining trial participation: • May treat eligible patients off-protocol with the one of the protocol treatment arms. • May have a strong inclination towards a specific treatment for a given patient. • May have concerns with the trial participation affecting their relationship with their patient. • Amount of time dedicated to the responsibilities of clinical research. • Training for clinical trials • Finding staff that is willing and eager to be involved in research procedures.
Patient’s Personal Support ? • Concerns from your family & friends. • Commitment- Time taken away from family events, community support, etc. • Social media, the internet, what’s in the news could be a barrier
Patient Attitude • This is the most important barrier to address. We have navigated through all these previous barriers. • Clinical Trials are available at a patient’s locate cancer clinic. • The protocol is being discussed with the patient by their physician, nursing staff, or a research team member. • You are given a consent form to read through. • And you have to decide to give your consent to participate in this clinical trial.
What is the consent process? • Your participation is voluntary • Prior to signing any document, your participation will be discussed with you. • Discuss the clinical trial participation with your family, your friends, your general practice doctor, your dentist, etc. • Who is looking out for my safety? • Has all of my questions been answered?
Other Factors in a Patient Life that will affect their decision • Transportation • Travel costs or lodging • Delay of insurance approval • Is this information available in my native language • Availability of child care
Choose to be made. Standard of Care Treatment Participate in the Clinical Trial OR
References: • The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies. (https://www.ncbi.nlm.nih.gov/pubmed/27249699) • Children’s Oncology Group, (https://www.childrensoncologygroup.org/index.php/what -is-a-clinical-trial) • https://ncorp.cancer.gov • http://mcrconline.org/content/about-mcrc-ccop • Comprehensive Cancer Alliance for Idaho (CCAI) 2016 Data • Cancer Patient Dresses As Wonder Woman For Last Day Of Chemo, Becomes Our New Hero. (https://www.huffingtonpost.co.uk/2015/11/26/cancer-patients-dresses-wonder-woman-chemo_n_8654586.html) • The Male Breast Cancer Coalition: Men Have Breasts Too. (https://medivizor.com/blog/2015/09/10/male-breast- cancer-coalition-men-breasts/)
THANK YOU.
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