Late Toxicity and Long-Term Quality of Life in Survivors of Cancer of the Major Salivary Glands More Than 5 Years After Diagnosis: A Multi-National Study.

Background: Because salivary gland cancers (SGC) are rare and include different tumor subtypes, data on their long-term quality of life and late toxicities are sparse.

Methods: Multi-national study including SGC survivors more than 5 years after diagnosis. They completed the European Organisation for Research and Treatment of Cancer (EORTC) quality of life core questionnaire together with its head and neck cancer module and reported problems that were most bothering for them.

Toxicities in long-term survivors of head and neck cancer-A multi-national cross-sectional analysis.

Head and neck cancer (HNC) patients may experience toxicities as a result of their treatment modality. While acute toxicities have been well documented, the prevalence of toxicities at long-term follow-up of HNC survivors is less clear. As part of a multi-national, cross-sectional study, HNC survivors at least 5 years post-diagnosis were invited to undergo a toxicity examination.

Flexibility in patient-reported outcome and health-related quality of life measurement: The EORTC Quality of Life Group measurement strategy.

The development of the first European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) health-related quality of life (HRQoL) questionnaires contributed to the systematic uptake of HRQoL as an endpoint in cancer clinical trials, and to the measurement of HRQoL for individual assessment in routine care. Following a modular approach, these patient-reported outcome (PRO) measures (PROMs) ensure that both generic and disease-specific issues are assessed, enabling comparison of PROs across groups and studies. The application of a comprehensive and continually refined methodology for developing and updating these PROMs has been crucial in supporting their psychometric and cross-cultural validity, and their continued implementation in clinical research.

Chronic fatigue in long-term survivors of head and neck cancer treated with radiotherapy.

Background: There is lack of evidence on chronic fatigue (CF) following radiotherapy (RT) in survivors of head and neck cancer (HNC). We aimed to compare CF in HNC survivors > 5 years post-RT with a reference population and investigate factors associated with CF and the possible impact of CF on health-related quality of life (HRQoL).

Material And Methods: In this cross-sectional study we included HNC survivors treated in 2007-2013.

Long-term health-related quality of life in head and neck cancer survivors: A large multinational study.

Head and neck cancer (HNC) patients suffer from a range of health-related quality of life (HRQoL) issues, but little is known about their long-term HRQoL. This study explored associations between treatment group and HRQoL at least 5 years' post-diagnosis in HNC survivors. In an international cross-sectional study, HNC survivors completed the European Organization for Research and Treatment of Cancer (EORTC) quality of life core questionnaire (EORTC-QLQ-C30) and its HNC module (EORTC-QLQ-H&N35).

Radiation-induced long-term dysphagia in survivors of head and neck cancer and association with dose-volume parameters.

Background: Although dysphagia is a common side effect after radiotherapy (RT) of head and neck cancer (HNC), data on long-term dysphagia is scarce. We aimed to 1) compare radiation dose parameters in HNC survivors with and without dysphagia, 2) investigate factors associated with long-term dysphagia and its possible impact on health-related quality of life (HRQoL), and 3) investigate how our data agree with existing NTCP models.

Methods: This cross-sectional study conducted in 2018-2020, included HNC survivors treated in 2007-2013.

Impact of hyperfractionated re-irradiation on quality of life in patients with recurrent or second primary head and neck cancer, a prospective single institutional study.

Purpose: Describe the clinical outcome of hyperfractionated re-irradiation (HFRT) in patients with recurrent or second primary (SP) head and neck cancer (HNC).

Methods: This prospective observational study included HNC patients eligible for HFRT. Inclusion criteria: age ≥18 years, recurrent or SP HNC, planned re-irradiation and ability to respond to questionnaires.

Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures.

Patient-reported outcomes (PROs), such as symptoms, functioning, and other health-related quality-of-life concepts are gaining a more prominent role in the benefit-risk assessment of cancer therapies. However, varying ways of analysing, presenting, and interpreting PRO data could lead to erroneous and inconsistent decisions on the part of stakeholders, adversely affecting patient care and outcomes. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) Consortium builds on the existing SISAQOL work to establish recommendations on design, analysis, presentation, and interpretation for PRO data in cancer clinical trials, with an expanded set of topics, including more in-depth recommendations for randomised controlled trials and single-arm studies, and for defining clinically meaningful change.

Serious Long-Term Effects of Head and Neck Cancer from the Survivors' Point of View.

The long-term problems of head and neck cancer survivors (HNCS) are not well known. In a cross-sectional international study aimed at exploring the long-term quality of life in this population, 1114 HNCS were asked to state their two most serious long-term effects. A clinician recorded the responses during face-to-face appointments.

A multicenter international prospective study of the validity and reliability of a COVID-19-specific health-related quality of life questionnaire.

Purpose: To develop and validate a health-related quality of life (HRQoL) questionnaire for patients with current or previous coronavirus disease (COVID-19) in an international setting.

Methods: This multicenter international methodology study followed standardized guidelines for a four-phase questionnaire development. Here, we report on the pretesting and validation of our international questionnaire.

Health-related quality of life in patients with COVID-19; international development of a patient-reported outcome measure.

Background: We aimed to create a questionnaire to assess the health-related quality of life including functioning, symptoms, and general health status of adult patients with current or previous COVID-19. Here, we report on Phase I and II of the development.

Methods: Internationally recognized methodology for questionnaire development was followed.

Comparing the use of patient-reported outcomes in clinical studies in Europe in 2008 and 2018: a literature review.

Purpose: Several guidelines for the use of patient-reported outcomes (PROs) in clinical studies have been published in the past decade. This review primarily aimed to compare the number and compliance with selected PRO-specific criteria for reporting of clinical studies in Europe using PROs published in 2008 and 2018. Secondarily, to describe the study designs, PRO instruments used, patient groups studied, and countries where the clinical studies were conducted.

Methodological approach for determining the Minimal Important Difference and Minimal Important Change scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module (EORTC QLQ-HN43) exemplified by the Swallowing scale.

Purpose: The aim of this study was to explore what methods should be used to determine the minimal important difference (MID) and minimal important change (MIC) in scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43.

Methods: In an international multi-centre study, patients with head and neck cancer completed the EORTC QLQ-HN43 before the onset of treatment (t1), three months after baseline (t2), and six months after baseline (t3). The methods explored for determining the MID were: (1) group comparisons based on performance status; (2) 0.

Health-related quality of life issues, including symptoms, in patients with active COVID-19 or post COVID-19; a systematic literature review.

Purpose: This systematic review was performed to identify all relevant health-related quality of life (HRQoL) issues associated with COVID-19.

Methods: A systematic literature search was undertaken in April 2020. In four teams of three reviewers each, all abstracts were independently reviewed for inclusion by two reviewers.

Cancer patients' diagnosis and symptoms and their family caregivers' self-efficacy and social support are associated with different caregiver reactions.

Objective: To describe caregiver and patient characteristics that are associated with negative and positive reactions in family caregivers (FCs) of cancer outpatients.

Methods: A total of 194 FCs completed the Caregiver Reaction Assessment (CRA) scale 6 months after start of new treatment in patients with breast, ovarian, colorectal, or head and neck cancer. Linear regression models were used to examine which caregiver characteristics (i.

International validation of the revised European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43: Phase IV.

Background: We validated the new European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43).

Methods: We enrolled 812 patients with head and neck cancer from 18 countries. Group 1 completed the questionnaire before therapy, and 3 and 6 months later.

Symptom burden and patient characteristics: Association with quality of life in patients with head and neck cancer undergoing radiotherapy.

Background: Patients with head and neck cancer (HNC) experience diminished quality of life (QOL) during and after treatment. This study examined which characteristics were associated with QOL over time.

Methods: One hundred thirty-three patients with HNC from a study of 534 oncology patients rated physical and mental QOL using the Short Form-12 5 times from the initiation of radiotherapy (RT) through the following 6 months.

Improved treatment decisions in patients with esophageal cancer.

Background: Patients with esophageal cancer seldom achieve long-term survival. This prospective cohort study investigated the selection of patients likely to benefit from curative treatment and whether information on patients' health-related quality of life (HRQL) would assist treatment decisions in the multidisciplinary team.

Methods: Consecutive patients completed HRQL assessments and clinical data were collected before start of treatment.

Patient factors and quality of life outcomes differ among four subgroups of oncology patients based on symptom occurrence.

Context: Reviews of the literature on symptoms in oncology patients undergoing curative treatment, as well as patients receiving palliative care, suggest that they experience multiple, co-occurring symptoms and side effects.

Objectives: The purposes of this study were to determine if subgroups of oncology patients could be identified based on symptom occurrence rates and if these subgroups differed on a number of demographic and clinical characteristics, as well as on quality of life (QoL) outcomes.

Methods: Latent class analysis (LCA) was used to identify subgroups (i.

International field testing of the psychometric properties of an EORTC quality of life module for oral health: the EORTC QLQ-OH15.

Purpose: This international EORTC validation study (phase IV) is aimed at testing the psychometric properties of a quality of life (QoL) module related to oral health problems in cancer patients.

Methods: The phase III module comprised 17 items with four hypothesized multi-item scales and three single items. In phase IV, patients with mixed cancers, in different treatment phases from 10 countries completed the EORTC QLQ-C30, the QLQ-OH module, and a debriefing interview.

The effects of age on health-related quality of life in cancer populations: A pooled analysis of randomized controlled trials using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 involving 6024 cancer patients.

Background: Cancer incidence increases exponentially with advancing age, cancer patients live longer than in the past, and many new treatments focus on stabilizing disease and HRQOL. The objective of this study is to examine how cancer affects patients' HRQOL and whether their HRQOL is age-dependent.

Methods: Data from 25 EORTC randomized controlled trials was pooled.

Changes in and predictors of pain characteristics in patients with head and neck cancer undergoing radiotherapy.

Pain is a common symptom in patients with head and neck cancer (HNC) that is associated with significant decrements in physical and psychological functioning. Only 4 studies have evaluated for changes in and predictors of different pain characteristics in these patients. In this longitudinal study of patients with HNC, changes in pain intensity (i.