Abstract
What do cancer researchers need the most to conduct their important research projects? Certainly funding. But without ‘tissue specimens’, clinical trials are delayed, and research that could save lives and possibly lead to a ‘cure’, just don't ‘happen’.
There are many ‘myths and misunderstandings’ about clinical trials, tissue donation, tissue banking, and research in general.
As a cancer patient advocate, and wife of a cancer patient, I became involved in learning about clinical trials as a way of finding out more about what treatment options were available. I had no idea of what' ‘tissue’ was and that cancer patients could ‘choose’ to participate in research. I met Michael Berens, PhD, Director of the Cancer and Cell Biology Division at TGEN, the Translational Genomics Research Institute, Phoenix, Az., at a research meeting in September, 2006 and heard the following statement. I knew it was time to take action!
“The use of tissue in research is vital for medical science to advance. The fastest way to accelerate breakthroughs in cancer diagnosis and treatment is to ensure access by researchers to properly consented, accurately annotated, and carefully preserved clinical specimens. Patients need to be aware of the enormous role that they can play by agreeing to allow ‘excess’ portion of their clinical specimens to be used in discovery and validation studies.'
I joined forces with pancreatic cancer patient and avid research advocate, Kay Kays, and we submitted a grant to the Arizona Department of Health Services, Cancer Control Program, for our Tissue Donor Awareness Program, TDAP™. The TDAP™ grant was awarded in March, 2007 to the Arizona Myeloma Network, the ‘grassroots’ myeloma charity that I had founded in 2004 and which became a 501(c)(3) non-profit organization in 2006.
Our goal was to bridge the gap between the cancer patient and the researcher. We developed a collaborative committee of scientists, researchers, oncology specialists, and cancer patients, who helped us to design and deliver our ‘free’, 2 hour, TDAP™ programs for the public.
Our programs discussed such questions as: ‘What is tissue?’ Why is it important to consider donating ‘excess tissue’ for cancer research? How is ‘tissue’ used in research? How can cancer patients help in the search for a ‘cure’?
We knew that it was important to promote better understanding among cancer patients, their families and caregivers about donating tissue and listen to community questions and concerns, in order to increase participation in clinical trials. And, we realized that no one really knew ‘why’ patients weren't already participating or requesting information about tissue donation and clinical trials.
With only 8 months to complete our study, April–November, we planned ‘focus’ groups/programs in three diverse communities: Phoenix, Prescott, and Tucson. We promoted TDAP™ in local newspapers, radio stations, websites, attended community groups, presented to cancer support groups and organizations, and met with cancer professionals, and sent out hundreds of emails throughout Arizona.
We also obtained additional funding and sponsorships from: Blue Cross/Blue Shield of Arizona, Millennium Pharmaceuticals, Celgene Corporation, and the Binding Site. And, we enlisted the support of some of the top scientists and oncology specialists to participate on our faculty panels, along with cancer patients who were currently or had participated in clinical trials. All cancer charities and organizations were invited to attend and to have display tables to share cancer information with the attendees at each program. The Programs were ‘free’, offered refreshments, and a box lunch following the presentation, to allow for interaction among patients, families, and faculty.
Our communications/flyers were ‘headlined’: ‘Cancer Community Awareness: If you have cancer and would like to make a real difference in improving treatment for you and future generations, this workshop is for you’.
‘The Tissue Donor Awareness Program, TDAP, What you need to know about donating tissue for cancer research.
You may be asked to donate some of your excess tissue that is not needed for your medical care. Before you make your decision, it may be helpful for you to learn more about tissue and why it is so important.
The use of tissue or specimens in research is vital for medical science to advance.”
All three workshops were listed on the calendar flyer, and people could register for any, or all of the workshops. A CEU certificate was offered for two general hours for each workshop and participants could register on line, by email, or phone. Each program was ‘tailored’ to the community—some were smaller and more informal, others were ‘theater style with a larger faculty panel, etc. The faculty included major researchers and also local oncologists, social workers, nurses, and patients. Volunteers from AzMN and other cancer groups assisted in registrations, doing the mailings, phone follow-up, and setting up information tables, handing out lunches, and joining in the discussions. It was truly a ‘team’ effort with collaboration at every level.
Evaluation: Evaluations forms were completed at all the programs, collated and included in the grant report. Over 500 people participated in the workshops, as well as smaller presentations throughout the eight-month grant schedule. Some of the presentations were to cancer support groups, medical practices, an organization of oncology nurses, an association of clinical research professionals, The Wellwoman Health Check; the Intertribal Council of Arizona's annual Board meeting; the Asian Pacific Community in Action; PanCan; TheWellness Community, Phoenix; Us Too International (a prostate cancer organization); as well as social and business groups in Barbara's and Kay's own communities.
Many important questions were raised at these programs and meetings: What is tissue? What is a clinical trial? How do we actually donate this tissue? Who do we contact at hospitals to promote tissue donations? What are the legal implications? How is my privacy protected? How do I get my physician involved in using my tissue for research?
Results: Over 65% of the participants reported that they felt that they had ‘learned a lot’, and that they were ‘more likely to donate tissue if they had an opportunity to do so.’ They also felt that they had a better understanding of tissue donation and clinical trials. They also stated that they felt more comfortable about making an informed decision about participating in clinical trials.
Over 80% said that they would recommend the TDAP™ program to others and would like to have additional programs in their community.
Community Awareness is another important element of this type of program and TDAP™ has provided this through the following activities:
The TDAP™ program was publicized at the Diamondbacks Baseball game as part of the AzMN Charity Corner on September 5th, 2007, when over 1500 AzMN/TDAP flyers were distributed at the baseball game and 300 cancer patients and families were given free tickets by AzMN/Dbacks to attend the game.
On May 12th, 2008, Kendra Sabol, Director of the Arizona Cancer Control Program, and grant manager of the TDAP™ project, presented a Poster at the National Comprehensive Cancer Control Program Directors' Meeting, co-sponsored by NCI and ACS, in Atlanta, Georgia.
On June 4th, 2008, Barbara Kavanagh and Kay Kays presented the TDAP™ program results at the Arizona Transnet Policy Development Retreat in Scottsdale. Their topic was: Patient Advocates in Research. The conference was sponsored by the Arizona Biomedical Research Commission and Arizona Hospitals and Healthcare Association, and coordinated by the Battelle Consulting group.
TDAP™ was also presented at the 2nd Annual, statewide, AzMN ‘Living with Myeloma Conference’, March 29, 2008. AzMn featured presentations by leading myeloma researchers on clinical trials and the latest myeloma research. Among the faculty participating was a well known researcher, medical doctor, and tribal healer, Dr. Donald Warne, a Lakota Sioux, who discussed the ‘barriers’ for Native Americans to participate in research.
Attending the Conference were representatives of several Arizona tribes and staff from the Ft. Defiance Hospital. They were so interested in this information that they invited AzMN to provide a similar conference for the Navajo Nation. On October 11, 2008, AzMN, a collaborative of cancer and healthcare resources, hospital staff and cancer patients from Ft. Defiance, held the 1st Ft. Defiance Cancer Awareness and Advocacy Conference at the Navajo Museum in Window Rock, Arizona. Our astounding response and results of the Ft.Defiance Cancer Conference, demonstrated that many Native Americans, over 260 at this Conference, want to ‘know more’, have information on new treatment, ‘new science’ as we term research, earlier diagnosis, screening, and what causes cancer. Many also wrote in their evaluations that they want to help others who have cancer, and are willing to be cancer patient advocates for their people. The collaboration included leading cancer foundations and organizations, such as TGEN, Scottsdale Healthcare, the John Wayne Cancer Foundation, and the Leukemia Lymphoma Society, created an atmosphere of sharing, learning, and community involvement. We have already been invited to plan the 2nd Ft. Defiance Conference in July 2009 and will be seeking funding and further collaborations.
Future Directions: We believe that the TDAP™ program can be adapted to other underserved populations, through education and culturally sensitive information. By involving the cancer patients and their families in planning their own programs and having open dialogue between ‘professionals’ and patients, there can be more interest and acceptance of research and ‘personal choice’. We realize that it will take ‘time’ and funding to reach out in a systematic way to develop trust and understanding. We hope to expand our workshops throughout the State and develop Cancer Patient Advocacy Training, CPAT™, a ‘train the trainer’ concept that will involve ‘local’ people to work in their own communities to provide cancer information and advocacy services with professional support.
We are currently also working with a TDAP Collaborative committee to design a program for hospital administrators, medical staff, and community oncologists, to better understand how to talk to patients about ‘tissue donation’ and implications for their own facilities. And, in December, AzMN was awarded a grant by the John C. Lincoln Foundation to develop a TDAP™ Program for the City of Glendale, which will be a first in Arizona and allow us to reach a diverse population in this community.
Challenges: There are many challenges, including financial, limited professional resources, decades of fear and distrust, as well as ‘resistance’ from physicians, the medical community, legal issues, tissue storage issues, and tissue ownership rights. There will need to be broader education of medical professionals, insurance companies, and the community in general to overcome these barriers.
The role of cancer patients and their loved ones will be critical to increasing tissue donation and funding more clinical trials. There will need to be more collaboration in the ‘fight’ for more research to improve cancer treatment and make it more accessible to all, and to work together with researchers to find the Cure!
As one of the Ft. Defiance conference attendees said: “I am a breast cancer survivor…I am alive and feeling good. I want to help my people and teach them that the word for cancer, ‘a sore that does not heal’ is not true. You can be helped—there is Hope!
Strategies to overcome barriers, increase awareness, and adapt research programs for the underserved will be addressed at the workshop.
Second AACR International Conference on the Science of Cancer Health Disparities— Feb 3–6, 2009; Carefree, AZ