Distress Screening in Head and Neck Cancer Patients Undergoing Active Cancer Directed Treatment and Impact of Referral to Psycho-Oncology and Palliative Care

Abstract

To estimate the prevalence of clinically significant distress (Distress score > or equal to 4) in Head and Neck cancer patients treated with a radical intent using the NCCN Distress thermometer (DT) and to evaluate the impact of referral to psycho-oncology and palliative care. This is a prospective study evaluating distress in head and neck cancer patients and patients were accrued from February 2016 to May 2017 (CTRI No. : CTRI/2016/01/006549). The study was conducted in two parts (Parts A and B). Part A: Total of 600 patients undergoing curative radiation therapy, aged more than 18 years, aware of their diagnosis and treatment plan ECOG 2 or less and signed inform consent were considered for accrual. Patients were screened for distress using DT at baseline. Part B: This is a prospective randomized controlled trial and 212 patients of Part A with score= 4 were randomly assigned to the control (care as usual by the treating physician) or intervention group (referral to psycho-oncology and palliative care). All patients were administered the DT with NCCN problem check list, Edmonton symptom assessment system (ESAS) and EORTC QLQ-C-30 and HN35 questionnaires at baseline and 6 month post treatment. Intention to treat analysis was done for Part B. Part A: Six hundred and twenty one patients were screened for the study and 600 patients were accrued in the study. The median distress score of entire cohort was 4 (IQR: 3-5) and clinically significant distress (score = 4) was seen in 340 patients (56.7%). At a median follow up of 15 months, patients with clinically significant distress had inferior survival (2 year: 91% v/s 96%; p=0.04). Part B: 340 patients with a distress score of 4 or more were screened for the Part B study and 212 patients were accrued in the study. The median distress score at baseline in both groups was 6 (IQR: 5-8). At 6 month follow up, the median distress score in both groups was 2 (IQR: 2-3). At 6 month follow up, there was no difference in clinically significant distress (4 or more) between the two groups (16% v/s 9.3%; p= 0.19). There was no difference in the distress checklist domains (physical, practical, family, spiritual and emotional) between the 2 groups. At 6 months follow up, there was reduction in all symptoms as measured by ESAS and improvement in quality of life (QOL) both groups however not statistically significant. At a median follow up of 23.5 months, 1 year and 2 year overall survival (OS) and disease free survival (DFS) rates were 87%, 66% and 75%, 65% respectively. There was no difference in OS, DFS and locoregional control between the arms. Clinically significant distress was seen in 56% of all head and neck cancer patients treated with a curative intent and the survival was significantly poor. Although there was improvement in the distress scores, symptom scores and QOL domains with psycho-oncology and palliative care referral, there was no statistically significant difference. The survival outcomes were similar between the groups.