Study Accrual…Study Accrual…Recruiting Across the SpectrumRecruiting Across the Spectrum

ACRIN – RA Education SessionSeptember 29, 2010Pentagon City, VA

Lorna Beccaria, RN, BSN, CCRC

Three Distinct TracksThree Distinct Tracks

• Working with Health Care Professionals

• Working with Community Members, Advocates and Underrepresented Populations

• Working with Patients in a Clinical Setting

GoalsGoals

• Enhance clinical trial accrual through outreach and education efforts at local institutions and in the community

• Increase clinical trial accrual/participation in underrepresented populations (women, minorities, rural communities, older patients with co-morbidities)

• Identify strategies for increasing patient accrual i.e. use of multimedia resources

ObjectivesObjectives

Learning Objectives:• Identify strategies to address barriers to

clinical trial participation• Assess the needs of specific groups: health

care professionals, community members, advocates & patients

• Incorporate key factors to tailor educational approaches for specific groups

Working with Health Care Working with Health Care ProfessionalsProfessionals

Barriers to Participation in Barriers to Participation in Clinical TrialsClinical Trials• Lack of awareness of appropriate clinical trials• Unwillingness to “lose control” of a patient’s care• Belief that standard therapy is best• Belief that referring and/or participating adds

administrative burden and cost• Unsure how to address patient concerns or

physician expertise about clinical trial participation

• Little connection between community cancer care and conduct of clinical research

Key MessagesKey Messages

• Educate Health Care Professionals:– Clinical trial design– How clinical trials work & advance care– Patient protection (IRB, consents, advocates)– How to respond to patient concerns– Ways to participate in clinical trials– Keep patient/physician engaged and involved– Accessing clinical trials resources

How to Reach Health Care How to Reach Health Care ProfessionalsProfessionals• Multimedia Resources (i.e. CTES slide show):

– Talks in physician offices, nurse educators, hospitals, tumor boards

– Talks at local and state medical societies

– Talks at professional meetings

• Letters, fax, email to solicit referrals

• Exhibits at conferences

• Local and national press coverage

Working with Community Working with Community Members, Advocates & Members, Advocates & Underrepresented PopulationsUnderrepresented Populations

Working with Community Working with Community Members and Advocates Members and Advocates • Provide “key” descriptions: define clinical trials,

describe type/phase of trial, purpose and significance

• Explain how clinical trials advance care• Discuss and respond to barriers and myths• Describe how patients are protected: informed

consent, IRB’s, FDA, advocates• Community and web based resources• Role of patient advocates in the research process

Underrepresented PopulationsUnderrepresented Populations

• Rural communities

• Elderly patients, especially those with co-morbidities

• Pediatric patients

• Women

• Minorities

• Patients with low literacy skills

Barriers for Underrepresented Barriers for Underrepresented PopulationsPopulations

• Language and literacy issues• Difficulty with transportation, child care, time off

from work• Cultural beliefs • Lack of health insurance and general health care• Concern about past abuses• Distrust of “Western” medicine

• Present clinical trials in a respectful, honest, easy-to-understand manner

• Address risks and benefits openly

• Stress importance of equal access to high quality health care, including clinical trials

• Be sure the informed consent process reflects participant’s understanding

How to Address BarriersHow to Address Barriers

How to Address Barriers (cont.)How to Address Barriers (cont.)

• Understand concerns of particular ethnic/cultural groups

• Provide evening/weekend appointments• Provide transportation, meal vouchers• Explain how subjects’ rights are protected

(don’t deny past abuses)• Have educational materials in patient’s native

language at his/her literacy level

Working with Patients in the Working with Patients in the Clinical SettingClinical Setting

General Barriers to Participation General Barriers to Participation in Clinical Trialsin Clinical Trials

• General Attitudes Toward Research

• Protocol Related Issues

• Logistical Concerns

• Influence of Others

• Decision Process/Other Issues

• Social Barriers

General Attitudes Toward Research General Attitudes Toward Research

• Unwilling to go against physician’s advice• Dislike of being “experimented on”• Mistrust of research• Lack of education about clinical trials• Perception that care will not be as good

Protocol Related IssuesProtocol Related Issues

• Dislike of randomization/possibility of the “placebo”

• Potential unknown side effects

• Trial treatments offer little or no personal benefits

Logistical ConcernsLogistical Concerns

• Increased personal cost

• Diminished or lack of health insurance coverage

• Inconvenience to everyday life, time impact, travel costs

Influence of OthersInfluence of Others

• Opinion of spouse, SO, family, friends or other support system

• Degree of the family support system

• Perceived strength or weakness of physician’s recommendation

• CRA’s recommendation or influence

Decision Process/Other IssuesDecision Process/Other Issues

• Fear of losing control over decision making process

• Feeling of being coerced to join

• Stress of diagnosis, especially if terminal

• Religious/spiritual beliefs

• Altruistic Motives

Social Barriers to Clinical TrialsSocial Barriers to Clinical Trials

• Low Income Participants, even when they have health insurance:– have more difficulty gaining access to care – face challenging circumstances such as:

• disconnected telephones, transportation issues

• multiple or inflexible jobs

• unaffordable copayments for medication

• often have cultural and language barriers

Social Barriers (continued)Social Barriers (continued)

– For low-income patients who obtain care:• treatment plans may also be complicated by

competing priorities. • many make tradeoffs between health care

and other basic needs, such as housing, food, and utilities.

Use of Multimedia Resources in Use of Multimedia Resources in the Clinical Settingthe Clinical Setting

• Patient oriented slide programs, videos, booklets and other publications (i.e. CTES)

• Social marketing

• Disease-based help lines– LiveHelp: from the NCI, offers live phone,

online & chat options– Need Answers?: from the ACS, offers 24/7 live

phone support

CTES (Clinical Trials Education CTES (Clinical Trials Education Series) ComponentsSeries) Components

• Publications

• Booklets

• DVD’s

• Slide Programs (CD-ROM) also in Spanish

• Online Training & Education Courses

Order from 1-800-4-CANCER (1-800-422-6237)or

download at www.cancer.gov/publications

Web Based Public Web Based Public Information/Recruitment (continued)Information/Recruitment (continued)

• AccrualNet.cancer.gov– Resource/professional community for clinical trial

accrual

• ResearchMatch.org– Registry for research volunteers and researchers

• Cancer.org – American Cancer Society

• ClinicalTrials.gov– Searchable database for patients, family & public

Coordinator Tactics!!!Coordinator Tactics!!!

In the context of a Breast MRI Clinical Trial• Pre-screen

– Clear and complete explanation of requirements of the procedures, provide informed consent etc

• MRI “trial run”• Use of anti-anxiety agents• Schedule of events, copies of all reports• Timely follow-up with patient and MD’s

ConclusionConclusion

THE KEY IS EDUCATION…

And

the RA is the Key Educator!