Quality of life changes over time and predictors in a large head and neck patients' cohort: secondary analysis from an Italian multi-center longitudinal, prospective, observational study-a study of the Italian Association of Radiotherapy and Clinical Oncology (AIRO) head and neck working group.

PURPOSE: The present study examined the longitudinal trajectories, through hierarchical modeling, of quality of life among patients with head and neck cancer, specifically symptoms burden, during radiotherapy, and in the follow-up period (1, 3, 6, and 12 months after completion of radiotherapy), through the M.D. Anderson Symptom Inventory Head and Neck questionnaire, formed by three factors. Furthermore, analyses were conducted controlling for socio-demographic as well as clinical characteristics. METHODS: Multi-level mixed-effects linear regression was used to estimate the association between quality of life and time, age, gender, household, educational level, employment status, ECOG performance status, human papilloma virus (HPV) status, surgery, chemotherapy, alcohol intake, and smoking. RESULTS: Among the 166 participants, time resulted to be a predictor of all the three questionnaire factors, namely, general and specific related symptoms and interference with daily life. Moreover, regarding symptom interference with daily activities factor, HPV-positive status played a significant role. Considering only HPV-negative patients, only time predicted patients' quality of life. Differently, among HPV-positive patients, other variables, such as gender, educational level, alcohol use, surgery, age at diagnosis, employment status, and ECOG status, resulted significant. CONCLUSION: It was evident that quality of life of patients with head and neck cancer declined during RT, whereas it slowly improved after ending treatment. Our results clarified the role of some socio-demographic and clinical variables, for instance, HPV, which would allow to develop treatments tailored to each patient.

Psychometric validation of the Chinese version of the M. D. Anderson Symptom Inventory-Head and Neck Module in patients with nasopharyngeal carcinoma.

Objective: The Chinese version of the M. D. Anderson Symptom Inventory-Head and Neck Module (MDASI-HN-C) has been linguistically validated. However, its psychometric properties have not been established yet. The purpose of the study was to psychometrically validate the MDASI-HN-C in patients with nasopharyngeal carcinoma (NPC). Methods: 130 Chinese NPC patients who were undergoing radiotherapy (RT) participated in this cross-sectional study. The content, convergent, and construct validity of the MDASI-HN-C were examined. The reliability of the instrument was tested by examining the internal consistency and test-retest reliability. Results: Cronbach's α coefficients ranged from 0.85 to 0.91 for the three subscales of the MDASI-HN-C. The 3-day test-retest reliability was acceptable with intraclass correlation coefficients (ICC) ranged from 0.52 to 0.71. The scale content validity index (S-CVI) was satisfactory (0.97). Subscale scores of the MDASI-HN-C were negatively correlated with the total score of the Chinese version of the Functional Assessment of Cancer Therapy-Head and Neck Scale (FACT-H&N-C) as hypothesized (r â€‹= â€‹-0.484 to -0.563, all P â€‹< â€‹0.01). Exploratory factor analysis (EFA) revealed two factors for the 13 core and another two for the nine HNC-specific items. Only one factor was generated for the six interference items. Conclusions: The MDASI-HN-C shows desirable psychometric properties for evaluating symptom burden in NPC patients, which can be used in both clinical and research contexts.

Comparing the M.D. Anderson Symptom and Dysphagia Inventories for Head and Neck Cancer Patients.

OBJECTIVES: Where patient-reported outcome measures (PROMs) may be administered at multiple patient visits, it is advantageous to capture these symptoms with as few questions as possible. In this study, the M.D. Anderson Head and Neck Symptom Inventory (MDASI-HN), and the M.D. Anderson Dysphagia Inventory (MDADI) is compared to determine if using the MDASI-HN alone would overlook symptoms identified with MDADI. METHODS: The MDASI-HN and the MDADI were completed by 156 patients, postradiotherapy for head and neck cancer (HNC). Associations between the two instruments were analyzed using correlation analysis, unsupervised machine learning, and sensitivity analysis. RESULTS: Little correlation was found between the two surveys; however, there was overlap between MDASI-HN dry mouth and many MDADI items, confirming that dry mouth is an important factor in difficulty swallowing, and patient QoL. Taking longer to eat (MDADI), was the most commonly reported item overall, with 85 (54%) patients rating it as moderate-severe. Dry mouth was the most endorsed MDASI-HN item (68, 44%). There were 51 patients missed by the MDASI-HN, reporting no moderate-severe symptoms, but reported one or more moderate-severe QoL impacts on MDADI. If patients who reported a score of 2 or higher on the MDASI-HN Dry Mouth item are flagged as requiring follow-up, the number of patients missed by MDASI-HN drops to 15. CONCLUSION: In an HNC clinic where MDASI-HN is routinely administered, assessment of symptoms and QoL might be enhanced by reducing the value at which MDASI Dry Mouth is considered moderate-severe to 2. LEVEL OF EVIDENCE: 3 Laryngoscope, 132:2388-2395, 2022.

M. D. Anderson symptom inventory head neck (MDASI-HN) questionnaire: Italian language psychometric validation in head and neck cancer patients treated with radiotherapy ± systemic therapy - A study of the Italian Association of Radiotherapy and Clinical Oncology (AIRO).

PURPOSE: Head and neck cancer (HNC) patients are likely to develop severe side effects, which may persist long after the end of treatment and may be responsible for decrease patient's quality of life. The M.D. Anderson Symptom Inventory- Head and Neck Module (MDASI-HN) is a questionnaire developed to detect patient's symptom burden. To conduct an Italian language psychometric validation of MDASI-HN among Italian HNC patients on behalf of the Italian Association of Radiotherapy and Clinical Oncology (AIRO) Head and Neck Working Group. METHOD AND MATERIALS: To assess construct validity, it was performed a confirmatory factor analysis (CFA) with both a five-factor solution and three-factor solution, which were compared by a chi-square difference test. The concurrent validity was evaluated by the correlation with EORTC QLQ-C30 and HN35, and it was also assessed known-group validity. The internal consistency was tested using Cronbach's alpha coefficient. RESULTS: In total 166 patients (71.7% male) were included in the study, most of patients (56.2%) had an oropharynx cancer and received definitive chemoradiotherapy (51.2%). The chi-square difference test was significant and indicated that the five-factor solution fits the data better than the other one. Regarding CFA, all items had a significant saturation with their respective factors; besides, significant and strong correlations were found among factors. Most of the correlations between MDASI-HN factors and EORTC QLQ-C30 and HN35 were significant. It was found a good internal consistency. CONCLUSION: The MDASI-HN is a valid, short, and easy patient-reported outcome questionnaire which would be useful and efficient in clinical setting.

Self-management intervention for head and neck cancer couples: Results of a randomized pilot trial.

BACKGROUND: Patients with head and neck cancer (HNC) experience significant physical and psychological morbidity during radiotherapy (RT) that contributes to treatment interruptions and a poor quality of life. Although spouses/partners can help by encouraging patient self-management (eg, self-care) during RT, they often experience high psychological distress rates, lack basic health care knowledge and skills, and report increased marital conflict regarding patient self-management. The current pilot study examined the feasibility and acceptability of a 6-session telephone-based intervention called Spouses coping with the Head And neck Radiation Experience (SHARE), which teaches self-management, communication, and coping skills to patients with HNC and their spouses. The treatment effects of SHARE compared with usual medical care (UMC) in controlling patient physical symptoms and improving patient/spouse psychological and marital functioning also were examined. METHODS: Thirty patients who initiated RT and their spouses (60 participants; 40% of whom were racial/ethnic minorities) were randomized to SHARE or UMC, and preintervention and postintervention assessments were completed. RESULTS: Solid recruitment (70%) and low attrition rates (7%) demonstrated feasibility. Strong program evaluations and homework completion rates (72%) supported acceptability. Significant treatment effects (medium in magnitude) were observed for SHARE compared with UMC with regard to HNC-specific physical symptom burden (Cohen's d, -0.89) and symptom interference (Cohen's d, -0.86). Medium to large effects favoring SHARE also were found for patient and spouse depressive symptoms (Cohen's d, -0.84) and cancer-specific distress (Cohen's d, -1.05). CONCLUSIONS: The findings of the current study support the feasibility, acceptability, and preliminary efficacy of SHARE. They also suggest that programs that empower HNC couples with the necessary skills to coordinate care and manage the challenges of RT together hold great promise for controlling a patient's physical symptoms and improving the psychological functioning of both partners.

Stereotactic radiosurgery for trigeminal pain secondary to recurrent malignant skull base tumors.

OBJECTIVE: The objective of this study was to assess outcomes after Gamma Knife radiosurgery (GKRS) re-irradiation for palliation of patients with trigeminal pain secondary to recurrent malignant skull base tumors. METHODS: From 2009 to 2016, 26 patients who had previously undergone radiation treatment to the head and neck received GKRS for palliation of trigeminal neuropathic pain secondary to recurrence of malignant skull base tumors. Twenty-two patients received single-fraction GKRS to a median dose of 17 Gy (range 15-20 Gy) prescribed to the 50% isodose line (range 43%-55%). Four patients received fractionated Gamma Knife Extend therapy to a median dose of 24 Gy in 3 fractions (range 21-27 Gy) prescribed to the 50% isodose line (range 45%-50%). Those with at least a 3-month follow-up were assessed for symptom palliation. Self-reported pain was evaluated by the numeric rating scale (NRS) and MD Anderson Symptom Inventory-Head and Neck (MDASI-HN) pain score. Frequency of as-needed (PRN) analgesic use and opioid requirement were also assessed. Baseline opioid dose was reported as a fentanyl-equivalent dose (FED) and PRN for breakthrough pain use as oral morphine-equivalent dose (OMED). The chi-square and Student t-tests were used to determine differences before and after GKRS. RESULTS: Seven patients (29%) were excluded due to local disease progression. Two experienced progression at the first follow-up, and 5 had local recurrence from disease outside the GKRS volume. Nineteen patients were assessed for symptom palliation with a median follow-up duration of 10.4 months (range 3.0-34.4 months). At 3 months after GKRS, the NRS scores (n = 19) decreased from 4.65 ± 3.45 to 1.47 ± 2.11 (p < 0.001); MDASI-HN pain scores (n = 13) decreased from 5.02 ± 1.68 to 2.02 ± 1.54 (p < 0.01); scheduled FED (n = 19) decreased from 62.4 ± 102.1 to 27.9 ± 45.5 mcg/hr (p < 0.01); PRN OMED (n = 19) decreased from 43.9 ± 77.5 to 10.9 ± 20.8 mg/day (p = 0.02); and frequency of any PRN analgesic use (n = 19) decreased from 0.49 ± 0.55 to 1.33 ± 0.90 per day (p = 0.08). At 6 months after GKRS, 9 (56%) of 16 patients reported being pain free (NRS score 0), with 6 (67%) of the 9 being both pain free and not requiring analgesic medications. One patient treated early in our experience developed a temporary increase in trigeminal pain 3-4 days after GKRS requiring hospitalization. All subsequently treated patients were given a single dose of intravenous steroids immediately after GKRS followed by a 2-3-week oral steroid taper. No further cases of increased or new pain after treatment were observed after this intervention. CONCLUSIONS: GKRS for palliation of trigeminal pain secondary to recurrent malignant skull base tumors demonstrated a significant decrease in patient-reported pain and opioid requirement. Additional patients and a longer follow-up duration are needed to assess durability of symptom relief and local control.

An Investigation into Body Image Concerns in the Head and Neck Cancer Population Receiving Radiation or Chemoradiation Using the Body Image Scale: A Pilot Study.

INTRODUCTION: Body image (BI) can have a major impact on quality of life, sense of self, and self-confidence. BI concerns are underrepresented within the literature among patients treated with radiation therapy. This pilot study aimed to determine the prevalence of BI concerns among head and neck cancer patients receiving radiation alone or chemoradiation. METHODS: Using a cross-sectional descriptive study design, the Body Image Scale was completed by two cohorts of patients recruited consecutively in their last week of treatment (N = 15) or their follow-up appointment 8-24 weeks postradiation treatment (N = 15). RESULTS: The results revealed a minority of patients had moderate BI concerns in both cohorts. CONCLUSION: The data suggest BI concerns dissipate over time as those in the follow-up cohort reported lower Body Image Scores. Further research into BI within this population would allow a deeper understanding into the global impact of radiation therapy.

Linguistic Validation of the Turkish Version of the M.D. Anderson Symptom Inventory - Head and Neck Cancer Module.

BACKGROUND: The use of patient symptom reports with frequent symptom assessment may be preferred over the more commonly used health-related quality of life questionnaires. AIMS: We sought to linguistically validate the Turkish version of the M.D. Anderson Symptom Inventory-Head and Neck module (MDASI-HN) patient reported outcome questionnaire. STUDY DESIGN: Validation study. METHODS: Following standard forward and backward translation of the original and previously validated English MDASI-HN into a Turkish version (T-MDASI-HN), it was administered to patients with head and neck cancer able to read and understand Turkish. Patients were then cognitively debriefed to evaluate their understanding and comprehension of the T-MDASI-HN. Individual and group responses are presented using descriptive statistics. RESULTS: Twenty-six participants with head and neck cancer completed the T-MDASIHN and accompanying cognitive debriefing. Overall, 97 percent of the individual TMDASI-HN items were completed. Average recorded time to complete the 28 item TMDASI-HN questionnaire was 5.4 minutes (range 2-10). Average overall ease of completion, understandability, and acceptability were favorably rated at 1.0, 1.1, and 0.2, respectively, on scales from 0 to 10. Only 5 of the 26 of participants reported trouble completing any single questionnaire items, namely the "difficulty remembering" item for 3 individuals. CONCLUSION: The T-MDASI-HN is linguistically valid with ease of completion, relevance, comprehensibility, and applicability and it can be a useful clinical and research tool.

Italian version of the M.D. Anderson Symptom Inventory--Head and Neck Module: linguistic validation.

BACKGROUND: Head and neck cancer (HNC) patients can experience symptoms due to the tumor itself or to the treatment, with an impact on health-related quality of life (HRQoL). Patient-reported outcome (PRO) measures pertaining to HRQoL are used in medical research and to support clinical decisions. PRO instrument applicability and cultural adaptation must be tested for each population. The aim of this study is to linguistically validate the Italian translation of the M.D. Anderson Symptom Inventory--Head and Neck Module (MDASI-HN). METHODS: Following forward and backward translation of the items of the English MDASI-HN into Italian, it was administered along with a cognitive debriefing to HNC patients able to read and understand Italian language. Individual and group responses are presented using descriptive statistics. RESULTS: From May 2013 through September 2013, 56 patients with HNC (18 during curative treatment, 20 in palliative chemotherapy, and 18 in follow-up period) completed the MDASI-HN followed by accompanying cognitive debriefing. Ninety-nine percent of the individual MDASI-HN items were completed. Average time to complete the MDASI-HN was 8.5 min (range 3-15). Results suggested overall ease of completion, relevance, and comprehensibleness of this translated self-report instrument in this Italian patient population. CONCLUSIONS: The Italian version of the MDASI-HN is linguistically valid; future research should explore dimensionality, reliability, and convergent, discriminant, and predictive validity of this patient-reported instrument, in order to use this translated version in outcomes research and clinical settings.

High symptom burden prior to radiation therapy for head and neck cancer: a patient-reported outcomes study.

BACKGROUND: As a first step toward developing effective strategies to control symptoms associated with head and neck cancer (HNC) and its treatment, we sought to describe the pattern of symptoms experienced before radiation therapy. METHODS: Subjects completed the MD Anderson Symptom Inventory-Head and Neck Module before beginning radiation therapy. RESULTS: In all, 270 patients participated. Symptom severity and interference varied between treatment-naïve patients and those with prior treatment. Cluster analyses revealed that 33% of patients had high symptom burden. Symptoms most often rated moderate-to-severe were fatigue, sleep disturbance, distress, pain, and problems chewing and swallowing. Poorer performance status, higher T classification, and receipt of previous treatment correlated with higher symptom burden. CONCLUSIONS: A substantial proportion of patients were experiencing high symptom burden. Because few interventions currently exist for several of the most problematic symptoms, research in symptom reduction that targets the pattern of symptoms described here is greatly needed.

Linguistic validation of the Greek M.D. Anderson Symptom Inventory - Head and Neck Module.

BACKGROUND: Our goal is to linguistically validate the Greek translation of the M.D. Anderson Symptom Inventory Index - Head and Neck Module. PATIENTS & METHODS: Following forward and backward translation of the previously validated head and neck cancer specific items of the English MDASI-HN into Greek (G-MDASI-HN), it was administered along with a cognitive debriefing to head and neck cancer patients able to read and understand Greek. Individual and group responses are presented using descriptive statistics. RESULTS: From 02/2009 through 06/2009 30 subjects with head and neck cancer completed the G-MDASI-HN followed by completion of the accompanying cognitive debriefing. Ninety-eight percent of the individual G-MDASI-HN items were completed. "Voice" item was not completed by 5 patients. Average time to complete the G-MDASI-HN was 13.3 minutes. Average ease of completion was rated at 1.21 on a 0 to 10 scale with "0" being "very easy" and "10" being "very hard". Only 10% of patients reported trouble completing any item, namely "distress" and "numbness". CONCLUSIONS: The Greek-MDASI-HN is linguistically valid and a patient-reported instrument that can be used both in outcomes research and as a clinical tool.