Role of eHealth application Oncokompas in supporting self-management of symptoms and health-related quality of life in cancer survivors: a randomised, controlled trial.

BACKGROUND: Knowledge about the efficacy of behavioural intervention technologies that can be used by cancer survivors independently from a health-care provider is scarce. We aimed to assess the efficacy, reach, and usage of Oncokompas, a web-based eHealth application that supports survivors in self-management by monitoring health-related quality of life (HRQOL) and cancer-generic and tumour-specific symptoms and obtaining tailored feedback with a personalised overview of supportive care options. METHODS: In this non-blinded, randomised, controlled trial, we recruited patients treated at 14 hospitals in the Netherlands for head and neck cancer, colorectal cancer, breast cancer, Hodgkin lymphoma, or non-Hodgkin lymphoma. Adult survivors (aged ≥18 years) were recruited through the Netherlands Cancer Registry (NCR) and invited by their treating physician through the Patient Reported Outcomes Following Initial Treatment and Long term Evaluation of Survivorship (PROFILES) registry. Participants were randomly assigned (1:1) by an independent researcher to the intervention group (access to Oncokompas) or control group (access to Oncokompas after 6 months), by use of block randomisation (block length of 68), stratified by tumour type. The primary outcome was patient activation (knowledge, skills, and confidence for self-management), assessed at baseline, post-intervention, and 3-month and 6-month follow-up. Linear mixed models (intention-to-treat) were used to assess group differences over time from baseline to 6-month follow-up. The trial is registered in the Netherlands Trial Register, NTR5774 and is completed. FINDINGS: Between Oct 12, 2016, and May 24, 2018, 625 (21%) of 2953 survivors assessed for eligibility were recruited and randomly assigned to the intervention (320) or control group (305). Median follow-up was 6 months (IQR 6-6). Patient activation was not significantly different between intervention and control group over time (difference at 6-month follow-up 1·7 [95% CI -0·8-4·1], p=0·41). INTERPRETATION: Oncokompas did not improve the amount of knowledge, skills, and confidence for self-management in cancer survivors. This study contributes to the evidence for the development of tailored strategies for development and implementation of behavioural intervention technologies among cancer survivors. FUNDING: Dutch Cancer Society (KWF Kankerbestrijding).

Trends in treatment, incidence and survival of hypopharynx cancer: a 20-year population-based study in the Netherlands.

Hypopharynx cancer has the worst prognosis of all head and neck squamous cell cancers. Since the 1990s, a treatment shift has appeared from a total laryngectomy towards organ preservation therapies. Large randomized trials evaluating treatment strategies for hypopharynx cancer, however, remain scarce, and frequently this malignancy is evaluated together with larynx cancer. Therefore, our aim was to determine trends in incidence, treatment and survival of hypopharynx cancer. We performed a population-based cohort study including all patients diagnosed with T1-T4 hypopharynx cancer between 1991 and 2010 in the Netherlands. Patients were recorded by the national cancer registry database and verified by a national pathology database. 2999 patients were identified. The incidence increased significantly with 4.1% per year until 1997 and decreased non-significantly afterwards. For women, the incidence increased with 1.7% per year during the entire study period. Total laryngectomy as primary treatment significantly decreased, whereas radiotherapy and chemoradiation increased. The 5-year overall survival significantly increased from 28% in 1991-2000 to 34% in 2001-2010. Overall survival for T3 was equal for total laryngectomy and (chemo)radiotherapy, but for T4-patients the survival was significantly better after primary total laryngectomy (± adjuvant radiotherapy). This large population-based study demonstrates a shift in treatment preference towards organ preservation therapies. The 5-year overall survival increased significantly in the second decade. The assumed equivalence of organ preservation and laryngectomy may require reconsideration for T4 disease.

Patterns of structural recurrence in papillary thyroid cancer.

BACKGROUND: Papillary thyroid carcinoma (PTC) is uncommonly associated with tumor-related mortality, although local recurrence can be a frequent and difficult problem. This study was conducted to clarify the pattern of structural locoregional recurrence in PTC. MATERIAL AND METHOD: A retrospective cohort study of patients undergoing surgical intervention for PTC was undertaken. Data were collected from a comprehensive thyroid cancer database maintained within a single tertiary referral center. The primary outcome measure was cancer recurrence requiring surgical intervention. Secondary outcome measures were site of recurrence, time to recurrence, and risk factors for recurrence. RESULTS: In the period 1980-2013, 1,183 patients with PTC were included in the study. The overall rate of structural recurrence requiring reoperative surgery was 7.9 %. The median time to reoperation was 31 months. Younger age, male gender, large primary tumor diameter, and number of positive lymph nodes at initial presentation were all significantly associated with disease recurrence. The lateral compartments (levels I, II, III, IV, V) were involved almost twice as frequently as the central compartment (level VI) (67 vs 32 %, P < 0.01). The distribution of recurrences was level I (1 %), level II (12 %), level III (18 %), level IV (18 %), level V (17 %), level VI (32 %), level VII (2 %). CONCLUSIONS: In a center with a liberal approach to central compartment lymph node dissection for PTC, the lateral neck compartment is the most common site of structural recurrence requiring reoperative surgery.

Decisional Conflict in Patients with Advanced Laryngeal Carcinoma: A Multicenter Study.

OBJECTIVES: Decision-making for patients with a locally advanced laryngeal carcinoma (T3 and T4) is challenging due to the treatment choice between organ preservation and laryngectomy, both with different and high impact on function and quality of life (QoL). The complexity of these treatment decisions and their possible consequences might lead to decisional conflict (DC). This study aimed to explore the level of DC in locally advanced laryngeal carcinoma patients facing curative decision-making, and to identify possible associated factors. METHODS: In this multicenter prospective cohort study, participants completed questionnaires on DC, level of shared decision-making (SDM), and a knowledge test directly after counseling and 6 months after treatment. Descriptive statistics and Spearman correlation tests were used to analyze the data. RESULTS: Directly after counseling, almost all participants (44/45; 98%) experienced Clinically Significant DC score (CSDC >25, scale 0-100). On average, patients scored 47% (SD 20%) correct on the knowledge test. Questions related to radiotherapy were answered best (69%, SD 29%), whilst only 35% (SD 29%) of the questions related to laryngectomy were answered correctly. Patients' perceived level of SDM (scale 0-100) was 70 (mean, SD 16.2), and for physicians this was 70 (SD 1.7). CONCLUSION: Most patients with advanced larynx cancer experience high levels of DC. Low knowledge levels regarding treatment aspects indicate a need for better patient counseling. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:3604-3610, 2024.

Does Prophylactic Replacement of Voice Prosthesis Make Sense? A Study to Predict Prosthesis Lifetime.

OBJECTIVE: Voice prosthesis leakage significantly affects the quality of life of patients undergoing laryngectomy, causing insecurity and frequent unplanned hospital visits and costs. In this study, the concept of prophylactic voice prosthesis replacement was explored to prevent leakages. STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary hospital. METHODS: This study included all patients who underwent laryngectomy between 2000 and 2012 in the Netherlands Cancer Institute. Device lifetimes and voice prosthesis replacements of a retrospective cohort were used to calculate the number of needed voice prostheses per patient per year to prevent 70% of the leakages by prophylactic replacement. Various strategies for the timing of prophylactic replacement were considered: adaptive strategies based on the individual patient's history of replacement and fixed strategies based on the results of patients with similar voice prosthesis or treatment characteristics. RESULTS: Patients used a median 3.4 voice prostheses per year (range, 0.1-48.1). We found high inter- and intrapatient variability in device lifetime. When prophylactic replacement is applied, this would become a median 9.4 voice prostheses per year, which means replacement every 38 days, implying >6 additional voice prostheses per patient per year. The individual adaptive model showed that preventing 70% of the leakages was impossible for most patients and only a median 25% can be prevented. Monte-Carlo simulations showed that prophylactic replacement is not feasible due to the high coefficient of variation (SD/mean) in device lifetime. CONCLUSION: Based on our simulations, prophylactic replacement of voice prostheses is not feasible due to high inter- and intrapatient variation in device lifetime.

Optimizing Survival Predictions of Hypopharynx Cancer: Development of a Clinical Prediction Model.

OBJECTIVES: To develop and validate a clinical prediction model (CPM) for survival in hypopharynx cancer, thereby aiming to improve individualized estimations of survival. METHODS: Retrospective cohort study of hypopharynx cancer patients. We randomly split the cohort into a derivation and validation dataset. The model was fitted on the derivation dataset and validated on the validation dataset. We used a Cox's proportional hazard model and least absolute shrinkage and selection operator (LASSO) selection. Performance (discrimination and calibration) of the CPM was tested. RESULTS: The final model consisted of gender, subsite, TNM classification, Adult Comorbidity Evaluation-27 score (ACE27), body mass index (BMI), hemoglobin, albumin, and leukocyte count. Of these, TNM classification, ACE27, BMI, hemoglobin, and albumin had independent significant associations with survival. The C Statistic was 0.62 after validation. The model could significantly identify clinical risk groups. CONCLUSIONS: ACE27, BMI, hemoglobin, and albumin are independent predictors of overall survival. The identification of high-risk patients can be used in the counseling process and tailoring of treatment strategy or follow-up. LEVEL OF EVIDENCE: 4 Laryngoscope, 130:2166-2172, 2020.

Improving decision making in larynx cancer by developing a decision aid: A mixed methods approach.

OBJECTIVE: Patients diagnosed with advanced larynx cancer face a decisional process in which they can choose between radiotherapy, chemoradiotherapy, or a total laryngectomy with adjuvant radiotherapy. Clinicians do not always agree on the best clinical treatment, making the decisional process for patients a complex problem. METHODS: Guided by the International Patient Decision Aid (PDA) Standards, we followed three developmental phases for which we held semi-structured in-depth interviews with patients and physicians, thinking-out-loud sessions, and a study-specific questionnaire. Audio-recorded interviews were verbatim transcribed, thematically coded, and analyzed. Phase 1 consisted of an evaluation of the decisional needs and the regular counseling process; phase 2 tested the comprehensibility and usability of the PDA; and phase 3 beta tested the feasibility of the PDA. RESULTS: Patients and doctors agreed on the need for development of a PDA. Major revisions were conducted after phase 1 to improve the readability and replace the majority of text with video animations. Patients and physicians considered the PDA to be a major improvement to the current counseling process. CONCLUSION: This study describes the development of a comprehensible and easy-to-use online patient decision aid for advanced larynx cancer, which was found satisfactory by patients and physicians (available on www.treatmentchoice.info). The outcome of the interviews underscores the need for better patient counseling. The feasibility and satisfaction among newly diagnosed patients as well as doctors will need to be proven. To this end, we started a multicenter trial evaluating the PDA in clinical practice (ClinicalTrials.gov Identifier: NCT03292341). LEVEL OF EVIDENCE: NA Laryngoscope, 129:2733-2739, 2019.

Postlaryngectomy prosthetic voice rehabilitation outcomes in a consecutive cohort of 232 patients over a 13-year period.

BACKGROUND: With the increasing necessity for total laryngectomy (TL) after prior (chemo)radiotherapy, prosthetic vocal rehabilitation outcomes might have changed. METHODS: Retrospective cohort study including all patients laryngectomized between 2000 and 2012 with a voice prosthesis (VP) in the Netherlands Cancer Institute. RESULTS: Median device lifetimes of the standard Provox2 and Vega VPs are 63 and 66 days, respectively, and for the problem-solving ActiValve Light and Strong VPs 143 and 186 days, respectively. In multivariable analysis, salvage TL and TL for a dysfunctional larynx (compared to primary TL) were associated with a shorter device lifetime. Almost half of the patients (48%) experienced tracheoesophageal puncture tract-related problems, and this concerned 12% of all VP replacements. CONCLUSIONS: Compared to historical cohorts, device lifetimes of regular Provox2 and Vega voice prostheses have decreased. Complications are not occurring more frequently but affect more patients. Nevertheless, the clinical reliability and validity of prosthetic voice rehabilitation is still sound.

Dilation after laryngectomy: Incidence, risk factors and complications.

BACKGROUND: Neopharyngeal stenosis is a recognized sequela of total laryngectomy (TL). We aim to investigate the incidence of stenosis requiring dilation, risk factors for stenosis and complications of dilation. METHODS: Retrospective cohort study of patients undergoing TL in two dedicated head and neck centers in the Netherlands. RESULTS: A total of 477 patients, (81% men, median age of 64 at TL) were included. Indication for TL was previously untreated primary tumor in 41%, salvage following (chemo)radiotherapy (CRT) in 44%, dysfunctional larynx in 9% and a second primary tumor in 6%. The cumulative incidence of dilatation at 5 years was 22.8%, and in total 968 dilatations were performed. Median number of dilations per patient was 3 (range 1-113). Female gender, a hypopharynx tumor, and (C)RT before or after the TL were significantly associated with stenosis requiring dilation. We observed 8 major complications (0.8%) predominantly during the first dilation procedures. Use of general anesthesia is a risk factor for complications. The most frequent major complication was severe esophageal perforation (n = 6 in 5 patients). CONCLUSION: The cumulative incidence of pharyngeal stenosis needing dilation was 22.8% at 5 years. Roughly half of these patients could be treated with a limited number of dilations, the rest however needed ongoing dilations. Major complications are rare (0.8%) but can be life threatening. General anesthetics is a risk factor for complications, and complications occurred predominantly during the first few dilations procedures. This should alert the physician to be extra careful in new patients.

Development and external validation of a risk-prediction model to predict 5-year overall survival in advanced larynx cancer.

OBJECTIVES/HYPOTHESIS: TNM-classification inadequately estimates patient-specific overall survival (OS). We aimed to improve this by developing a risk-prediction model for patients with advanced larynx cancer. STUDY DESIGN: Cohort study. METHODS: We developed a risk prediction model to estimate the 5-year OS rate based on a cohort of 3,442 patients with T3T4N0N+M0 larynx cancer. The model was internally validated using bootstrapping samples and externally validated on patient data from five external centers (n = 770). The main outcome was performance of the model as tested by discrimination, calibration, and the ability to distinguish risk groups based on tertiles from the derivation dataset. The model performance was compared to a model based on T and N classification only. RESULTS: We included age, gender, T and N classification, and subsite as prognostic variables in the standard model. After external validation, the standard model had a significantly better fit than a model based on T and N classification alone (C statistic, 0.59 vs. 0.55, P < .001). The model was able to distinguish well among three risk groups based on tertiles of the risk score. Adding treatment modality to the model did not decrease the predictive power. As a post hoc analysis, we tested the added value of comorbidity as scored by American Society of Anesthesiologists score in a subsample, which increased the C statistic to 0.68. CONCLUSIONS: A risk prediction model for patients with advanced larynx cancer, consisting of readily available clinical variables, gives more accurate estimations of the estimated 5-year survival rate when compared to a model based on T and N classification alone. LEVEL OF EVIDENCE: 2c. Laryngoscope, 128:1140-1145, 2018.