Randomized Trial Assessing the Impact of Routine Assessment of Health-Related Quality of Life in Patients with Head and Neck Cancer

Abstract

The impact of routine assessment of health-related quality of life (HRQoL) on satisfaction with care and the HRQoL of patients with head and neck cancer (HNC) treated with radiotherapy was assessed. Patients with HNC were randomly assigned to two arms, with stratification on sex, cancer localization, and stage of the disease. In the intervention arm, the patients completed the EORTC QLQ-C30 and EORTC QLQ-H&N35 questionnaires first before randomization, then before each medical appointment during radiotherapy (7 weeks), and then every 3 months until 1 year and at 2 years thereafter. In the control arm, the EORTC QLQ-C30 and EORTC QLQ-H&N35 questionnaires were completed before randomization and at 1 year and 2 years thereafter. The primary endpoint was mean change in HRQoL at score at 2 years from baseline assessed by EQ VAS from the EuroQol questionnaire. The secondary endpoint was mean change in satisfaction with care at 2 years from baseline assessed by QLQ-SAT32. Two hundred patients with head and neck cancers were involved in this study (mean age, 58.83 years (range, 36.56–87.89)), of whom 100 were assigned to the intervention arm and 100 to the control arm. Patients in the intervention arm were reported to have a statistically significant increase in EQ VAS at 2 years (p < 0.0001) and exceeded the minimal clinically important difference (mean change at 2 years from baseline = 10.46). In the two arms, mean differences between arms were not statistically significant, but minimal clinically important differences in favor of the intervention arm were found for EQ VAS (mean change difference (MD) = 5.84), satisfaction with care, in particular waiting times (MD = 10.85) and satisfaction with accessibility (MD = 6.52). Routine assessment of HRQoL improves HRQoL and satisfaction with care for patients with HNC treated with radiotherapy.

Dental implant treatment in patients with cancer on high‐dose antiresorptive medication: A prospective feasibility study with 2 years follow‐up

“…Surprisingly, it turned out that the QLQ‐H&N‐35 questionnaire was not found relevant for the included patients, even though it contains oral related questions. The major difference from studies which used the H&N‐35 successfully is that the patients in the present study did not suffer from head and neck cancer, but prostate cancer, breast cancer, colon cancer, or multiple myeloma (Billa et al., 2021; Melan et al., 2021).…”

Effects of routine collection of patient-reported outcomes on patient health outcomes in oncology settings: A systematic review

“…In seven studies, the clinician asked or recommended contacting the patient if the PRO measures score reached the alert threshold, 26 , 27 , 28 , 30 , 31 , 32 , 33 two studies sent knowledge support materials, 17 , 21 and seven studies placed PROM summaries in the medical records or sent them to health providers before the clinical visit as a reference. 11 , 13 , 15 , 29 , 34 , 35 , 36 Three studies (19%) adopted a comprehensive theoretical model and framework or had clinicians follow specific guidelines for PROs feedback. 11 , 15 , 21 Nine trials (56%) implemented PROs intervention every week, two trials (13%) daily, and two trials (13%) monthly.…”

“…Eighteen PRO measures were administered in the reviewed trials to deliver the interventions ( Table 3 ). Ten RCTs relied on only one intervention PRO measure, three RCTs two PRO measures, 34 , 35 , 36 and two RCTs three or more PRO measures. 11 , 27 The most frequently used PRO measures were the European Organization for Research and Treatment of Cancer series questionnaire C30 ( n ​= ​4) 27 , 34 , 35 , 36 and the PROs version of the Common Terminology Criteria for Adverse Events ( n ​= ​4).…”

“…Ten RCTs relied on only one intervention PRO measure, three RCTs two PRO measures, 34 , 35 , 36 and two RCTs three or more PRO measures. 11 , 27 The most frequently used PRO measures were the European Organization for Research and Treatment of Cancer series questionnaire C30 ( n ​= ​4) 27 , 34 , 35 , 36 and the PROs version of the Common Terminology Criteria for Adverse Events ( n ​= ​4). 13 , 15 , 21 , 28 Twelve trials (75%) administrated PRO measures via electronic platforms and two (13%) via telephone.…”

“…Nine trials (56%) were rated low for the randomization process, two (100%) for the timing of identification or participant recruitment, seven (44%) for deviations from the intended interventions, sixteen (100%) for missing outcome data, two (13%) for measurement of the outcome (given that it is not possible to blind the participants, and most of the outcomes are not objective but also come from patients), and ten (63%) for selection of the reported result. Overall, 9 trials (56%) were rated as low-risk in three or more bias categories 15 , 17 , 21 , 28 , 29 , 31 , 32 , 33 , 36 and 15 trials (94%) were rated as high for overall risk due to large bias in the outcome measurements.…”