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Keywords:

  • Phase I trials;
  • ethics;
  • research ethics;
  • hospice;
  • palliative care;
  • informed consent

Abstract

BACKGROUND

Phase I oncology trials offer no meaningful chance for direct medical benefit and they may prevent patients with advanced cancer from receiving palliative care in a hospice program. However, it is not known whether dual enrollment in a Phase I trial and hospice is feasible.

METHODS

Five hundred thirty-four Phase I trials were identified in a national online database, of which 179 (34%) accepted patients with a life expectancy of less than 6 months. Of these, 50 were selected randomly. Their principal investigators were surveyed by fax, with follow-up telephone calls and e-mails. Ninety-two hospices were selected randomly from a national database. Surveys were conducted by telephone with intake coordinators. Principal investigators were asked whether patients enrolled in hospice could also enroll in their trials if they were eligible in all other respects. Hospice intake coordinators were asked whether a patient with advanced cancer who met hospice eligibility criteria could also enroll in a Phase I trial.

RESULTS

Surveys were completed by 45 of 50 principal investigators (90%) and by 89 of 92 hospices (97%). Although both groups were in favor of dual enrollment, principal investigators (41 of 45; 91%) were more likely to support dual enrollment than hospices (60 of 89; 67%; chi-square test, P = 0.004). Most hospices that did not support dual enrollment cited reasons that were based on concerns about payment or misunderstandings about the nature of Phase I trials.

CONCLUSIONS

Most hospices and Phase I principal investigators believe that eligible patients should be allowed to enroll simultaneously in hospice and Phase I trials. These results suggest that the choice between hospice and a Phase I trial is a false dilemma and that greater collaboration in this area is needed. Cancer 2002;95:1601–4. © 2002 American Cancer Society.

DOI 10.1002/cncr.10820