Session Item

 Around 30-50% of Head Neck  squamous cell cancer (HNSCC)patients experience elevated levels of distress. An elevated level of distress is associated with poor health related Quality of Life (QoL), decreased patient satisfaction, poor treatment compliance and possible reduced survival.  Can Specialist care may help in improving the outcomes!

This Randomized prospective trial from a single center in India enrolled HNSCC patients aged > 18 years who received curative  Radiation Therapy (RT) and had a baseline significant distress as per the NCCN distress thermometer (distress score ≥ 4).Patients were randomized into the Standard arm (STD),which included an assessment and interview with the treating physician for distress screening and alleviation, or the Interventional arm (INV), where psycho-oncology/ palliative care referral was done at baseline and every week during treatment. Block randomization was done in a1:1 allocation ratio with stratification for treatment (definitive vs. adjuvant), age (< 65 vs.≥65 years), and primary site (Oral cavity vs. non-oral cavity). The study's primary endpoint was the proportion of patients having significant distress 6 months post-treatment. The trial was powered to detect a 20% difference in significant distress between the 2 arms with 80% power and 5% significance level (2-sided), requiring 106 patients in each arm (10% attrition rate). The secondary endpoints included symptom burden assessment by the Edmonton Symptom Assessment Score (ESAS), QoL (assessed by EORTC QLQC30 & HN 35), and survival. The study was registered with the Clinical Trial Registry of India (CTRI/2016/01/006549)

Three hundred and forty patients were screened, 212 patients were randomized (n=104 STD, n=108 INV). At 6 months post-treatment completion, 89 and 90 were evaluable in the STD and INV, respectively. The median distress score at baseline for both arms was 6 (IQR:5-8). At 6 months post-treatment completion, the median distress score was 2(IQR:2-3) in both arms. There was no significant difference in the proportion of patients having significant distress at 6 months post-treatment completion in STD vs. INV (16 vs. 9.3%, p=0.19). There was no significant difference between arms in other distress checklist domains (physical, practical, family, spiritual and social). At 6 months after treatment, there was an improvement in all symptoms measured by the ESAS (pain, tiredness, drowsiness, nausea, lack of appetite) & the QoL for the entire cohort with no statistically significant difference between arms. The 3-year Overall Survival for STD vs. INV was (70 vs 66%, p=0.56).

Psycho-oncology and palliative care referral did not impact distress, symptom burden, quality of life or survival significantly in this randomized trial. The primary treating  oncologist should  screen for elevated distress in patients of HNSCC and continue to provide wholesome care for their patients.