H.O.P.E. & Healing: a randomized pilot study of structured palliative care referrals in recurrent ovarian cancer

Objectives: The inclusion of palliative care (PC) across the cancer continuum has been identified as a marker of high-quality cancer care. With limited PC specialists, integrated approaches may be necessary with the primary oncologist providing this care. However, recurrent ovarian cancer patients often have significant physical and/or emotional needs that may be best addressed by PC specialists. Our primary objective was to test the effect of a structured PC intervention on quality of life (QOL) for patients with recurrent ovarian cancer. Secondary objective was to assess the effect of the structured PC approach on overall survival. Methods: This was an IRB approved prospective randomized controlled trial at 2 academic institutions and was registered with clinicaltrials.gov (NCT02090582). Eligible patients included those with platinum resistant ovarian cancer or platinum sensitive cancer with a sentinel clinical event (recent bowel obstruction, liver metastases, pleural effusion or ascites). Subjects were randomized 1:1 to usual care versus a structured palliative care intervention (see Figure 1). Quality of life was assessed using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) and Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-PAL) at baseline and 12-week intervals. Wilcoxon tests were used to detect differences between arms. Overall survival was analyzed using Kaplan-Meyer curves. Results: A total of 54 subjects were enrolled from 5/2014-4/2016; 26 in the intervention arm and 28 in the control arm. Median follow up was 6.5 months (Range: 2-12months). Median age of subjects was 63 with an ECOG performance status of 1. The majority of patients were Caucasian (44; 81.5%) and had platinum resistant disease (37; 68.5%). Most patients had received between 1-3 prior lines of chemotherapy (34/54; 63%); 5 patients (9.2%) had received ≥6 lines of therapy. There was no difference in overall or subset QOL in patients receiving usual care compared to those in the structured PC arm (p=0.14). There were no differences in hospital admissions (p=0.96), days from last chemo to hospice admission (p=1.0), days from hospice admission to death (p=0.41), place of death (p=0.68) or number of PC appointments (p=0.30) between the two arms. Patients enrolled in the 2nd half of the cohort were more likely to die at home rather than in the hospital or inpatient hospice (p=0.01) compared to subjects enrolled early in the study period. 81% of subjects randomized to the intervention arm completed at least 1 QDACT assessment (range 1-17). Similarly, there was no overall survival difference between the 2 arms (9.3m vs 10.1m; p=0.21). Download : Download high-res image (146KB) Download : Download full-size image Conclusions: Structured integrated approaches between gynecologic oncology providers and PC specialists are feasible. The QDACT tool may be an effective, standardized measure to assess cancer symptom burden over time in this population. Further study is needed to identify interventions and collaborations that may have the greatest impact on QOL for recurrent ovarian cancer patients.