Palliative Care in Phase 1 Trials is Essential for Patients and Their Caregivers

Structured palliative care for patients enrolled in phase 1 studies is associated with increased duration of study participation by nearly 3 weeks, improved patient and caregiver quality of life (QOL), and reduced patient symptom and caregiver burden. These findings were presented during the ASCO20 Virtual Scientific Program.

The first step in the development of new cancer therapeutics is a phase 1 clinical trial. Typically, patients enrolled in these studies have exhausted standard therapies and study participation or hospice care are their only options. In addition, significant symptom burden and early trial discontinuation due to significant symptom burden can confound phase 1 trial outcomes, including toxicity profiles.

Researchers at Case Comprehensive Cancer Center in Cleveland, Ohio, sought to determine the palliative care needs of patients enrolled in phase 1 clinical trials and their caregivers, as well as the effects of structured palliative care on duration of study participation, adverse event (AE) and symptom profiles, and QOL compared with usual supportive care (Clinicaltrial.gov Identifier: NCT02543541).

For the study, 68 patients enrolled in phase 1 clinical trials were randomly assigned to receive structured palliative care or usual supportive care. In addition, 39 of their caregivers were enrolled and assigned to the same arm. The researchers obtained monthly quality of life metrics using the Functional Assessment of Cancer Therapy-General and Memorial Symptom Assessment Scale–Short Form for patients and the Quality of Life in Life Threatening Illness–Family Carer Version and Caregiver Reaction Assessment for caregivers. Use of palliative care resources was assessed for those in the palliative care arm, and referrals to supportive care services were assessed for those in the usual care arm. AEs recorded on the phase 1 trials were evaluated and compared between the study arms.

Patients in the palliative care arm participated in phase 1 studies for a mean duration of 132 days compared with 114 days for those in the usual care arm (P =.55). Total weighted AE rate (number of AEs × AE grade per month) was 26.9 and 34.0 in the palliative care and usual care arms, respectively (P =.53). Both patients and their caregivers in the palliative care arm experienced better QOL and lower symptom burden compared with those in the usual care arm. “Although the differences in outcomes were not statistically significant, all results favored structured palliative care,” the researchers reported.

Patients and their caregivers involved in phase 1 clinical trials have physical and psychosocial needs that warrant palliative care services, the researchers concluded. However, “a larger study is warranted to confirm these results and further develop the ideal palliative care intervention in these populations.”

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original abstract for a full list of disclosures.

Reference

Treasure ME, Daly BJ, Fu PF, Cao S, Meropol NJ, Dowlati A. A randomized, controlled trial of structured palliative care versus standard supportive care for patients enrolled on phase I clinical trials. Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl):abstr 3634.