Open to Options:

Training Cancer Research Staff to Enhance Clinical Trials Access Margo Michaels, Natasha Blakeney, Melissa Miller,

Kathleen Coyne, Bonnie Crawford, Margaret Stauffer, Mitch Golant, Jeff Belkora

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A Unique Partnership

… ensures that all people impacted by cancer are empowered by knowledge, strengthened by action, and sustained by community.

improves access to cancer clinical trials through education and collaboration with communities, health care providers, and researchers.

Our Ultimate Goal for the Patient with (Hematologic) Cancer: Better Quality Care

At first treatment, in the adjuvant setting, or at recurrence…how can we ensure that

Every eligible patient is offered the opportunity to participate

Every interested patient can make an informed decision

○Including “informed refusal” Every patient feels confident to ask all questions,

including, “is there a trial for me?”

Training Clinical Research Staff in Community Context

Patients diagnosed with hem-

onc cancers

Primary care providers

referring out for dx/tx

Oncologists treating hemonc pateints

Enhanced awareness and access to cancer clinical trialsReduction in anxietyEnhanced copingOptimal patient care

(Training)

(Decisional Counseling)

(Training)

Why are CCTs part of Comp Cancer Control?

• High-quality treatment option open to many patients, regardless of stage Access to CCTs: a key quality measure for the

delivery of quality cancer care (ACOSOG Accreditation Guidelines)

An established standard for the delivery of quality comprehensive cancer care.

• Placebos never used instead of appropriate medical treatment

• Less than 3% receive treatment through a clinical trial

• Participation rate is even lower among ethnic and racial minorities, older people, and the medically underserved

Harnessing Science: Advancing Care by Accelerating the Rate of Cancer Clinical Trial Participation. 108th Congress, Second Session (May 13, 2004). Serial No. 108-189.;  Christian, M. C., & Trimble, E. L. (2003);  Cancer clinical trials: A resource guide for outreach, education, and advocacy. (2006). Retrieved from the NCI web site: ttp://www.cancer.gov/clinicaltrials/resources/outreach-education-advocacy ; Digest Page: Boosting Cancer Trial Participation. (2008). Retrieved from the NCI web site: http://www.cancer.gov/clinicaltrials/digestpage/boosting-trial-participation ; Brawley, O. (2004); Murthy, V,H., Krumholz, H,M. & Gross, C.P. (2004); Stewart et al. (2007).

 

Why are CCTs part of Comp Cancer Control?

• Only 15% of patients offered CCTs as treatment option

Patients from minority groups or who are over 65 are even less likely to be offered participation in a cancer clinical trial

Simon, M. JCO. 22: 2046-2052; Sateren, W. B., et al. (2002); Wendler, D PLoS Med, Feb;3(2):e19.Epub 2005

Why are CCTs part of Comp Cancer Control?

Why Train Clinical Research Staff?

• They face a variety of challenges, which can lead to lower rates of accrual. These include:

determining which national trials they are best able to accrue patients to in a timely manner

finding effective ways to increase the participation rates – especially among minority groups

finding best ways to approach eligible patients to enroll in a study

having limited capacity to consent eligible non-English speaking patients

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Process • Participating sites include CSC Centers of

Excellence Philadelphia

Greater Cincinnati/Northern Kentucky

San Francisco Bay Area

• CSC Program Directors at each site recruit local cancer clinical trial investigators and staff to

participate in ENACCT training on optimal recruitment and retention practices

Provide1-on-1 treatment decision making counseling to blood cancer patients referred by local oncologists or who are self-referred

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Development of Unique, Innovative Curriculum

• Qualitative interviews• Development of 4 hour training program• Objectives:

Gain insight into provider concerns about barriers to recruitment and retention among medically underserved populations in local cancer clinical trials.

Explain the impact of changing demographics and personal culture within the clinical research setting.

Describe current issues and future directions related to cultural competency and cancer clinical trials at the individual and organizational level.

Identify optimal strategies to enhance patient interaction at 5 different points of encounter in the clinical trial setting.

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Design/Objectives/MeasuresStudy Design Pre-post evaluation

among oncology professionals trained at 3 community sites

Follow-up evaluation at 6 months, 12 months and yearly thereafter

Objective To assess how training

impacts knowledge and behaviour of clinical research staff to enhance access to cancer clinical trials

Changes in knowledge and behaviour toward patient clinical trials education and engagement with primary care providers

Preliminary Results

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Sample Characteristics (n=83)

Socio-demographic

91% Female

45% Nurses

27% Physicians

7% Clinical Research

Associates

Other

46% Med Oncology

8% Radiation Oncology

6% Surgical Oncology

6 Sessions: July 2009-June 2010

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Pre Post Outcomes:Cancer Clinical Trials Knowledge and

Behavioral Intent

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What one aspect of cancer clinical trials did you learn about during this segment of the

educational program? • Culturally and Linguistically Appropriate

Service (CLAS) standards Previously unaware of its mandate and relevance

• Consent Availability of short-form consent

• Health Literacy “Made me more aware of literacy as a barrier to clinical trials”

“Literacy is even more of a concern than I previously thought”

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Conclusions

• Training oncology professionals to strengthen recruitment and retention practices shows promise in promoting greater access among blood cancer patients to clinical trials as a potential treatment option.