Paula M' Fracasso, M'D', Ph'D'

1
Overcoming Barriers to Early Phase Clinical
Trials

• Paula M. Fracasso, M.D., Ph.D.
• Mark S. Walker, Ph.D

2
Coaching Intervention
Enrollment of Patients with Advanced Breast,
Colon, Lung, and Prostate Cancer
Assess for Enrollment into Early Clinical Trials
Baseline Evaluation
6 Month Evaluation
Randomization
Usual Care
3
Theoretical Model
Coach
4
Time Line
5
Screened Patients from March-September 2005
6
Patients Screened and Enrolled
37 Patients ineligible because of PS, wrong
stage, multiple malignancies, and non-English
speaking.
7
Patient Characteristics
8
Randomization
9
Longitudinal Data

• Sample including follow-up data n 41
• Demographics are similar to full sample
• Females younger than males (48.6 v 62.8)
• Breast younger than prostate (47.0 v 63.6)
• Education by gender

10
Trial Enrollment

• Trial Enrollment and Adherence to Care available
  on 36 patients

11
Trial Enrollment
12
Adherence to Care

• Very small numbers
• MD visits (n 36)
• Chemo visits (n 26)
• Radiation therapy (n 10)
• No difference Coach v. Usual Care
• Among Coached patients
• contacts ? missed MD visits (r -.603, p
  .029)
• contacts ? missed Chemo visits (r -.323, ns)

13
Other Outcomes

• No apparent effect of assignment on
• Attitudes toward Trials
• Perceptions of Racism
• Some evidence of effect on Medical Mistrust among
  less educated patients

14
Other Outcomes
15
Other Outcomes

• No apparent effect of assignment on Trust in
  Doctor
• Among coached patients
• contacts ? Trust in Doctor (p .038)
• Controlling for baseline values, contacts ?
  Trust in Doctor (ns, but significant with n
  50)

16
Other Outcomes
17
Summary

• No evidence of main effect of Coach intervention
  on any outcomes
• Some evidence that Coach intervention may be
  selectively beneficial for males / less educated
• Evidence that trials enrollment is related to
  attitude domains assessed in this study
• Some evidence that level of engagement ( of
  coach contacts) may relate to adherence and Trust
  in Doctor.

18
Challenges

• Low rate of enrollment
• Staffing
• Availability of early phase trials
• Confounding of gender education
• CATI programming error
• Need for more structured content delivery
  regarding clinical trials
• Need other intermediate trials-related outcomes
• Much larger sample size