Challenges and Pathways to Simultaneous Clinical Trial and Palliative Care Enrollment

A recent study detailed a process to provide palliative care simultaneously with a phase one clinical trial, the results of which were shared in a poster presentation during the Oncology Nursing Society 44th Annual Congress.

When patients exhaust their treatment options, they usually have three choices: enrollment in a clinical trial, a palliative care program, or hospice. Those who enroll in phase one trials typically have a projected survival of five to nine months, and a 3.8-10.6% response rate to investigational products. Because many patients choose to continue with their directed treatment regimen, they do not take part in advanced care planning discussions. Palliative care teams are able to not only transition patients from their usual treatment to investigational treatment, but also from investigational treatment to end of life care at the conclusion of the patient’s study participation. A patient’s quality of life (QoL) is not often considered: QoL was only considered a study’s endpoint in 2% of phase one trials. There are currently no data on palliative care’s impact on this population.

Including palliative care in the clinical trial enrollment process could help bridge the gap between research and clinical care. Potential positive outcomes with this approach include:

  • Reduce some of the clinical investigator’s burden
  • Improve patients’ QoL
  • Reduce End of Life care costs
  • Increase the number of patients enrolled in the trial who have advanced care planning discussions
  • Provide post-trial continuity
  • Extend life expectancy
  • Prolong length on trial
  • Achieve high rates of advance directive completion
  • More likely to die comfortably at home

Because the majority of phase one clinical trials take place in medical centers—where a palliative care team is available—it would be possible to refer these patients to palliative care automatically.

 

Brock A. The Role of Palliative Care in Phase 1 Clinical Trial Participants.