Study protocol of a prospective multicenter study comparing (cost-)effectiveness of a tailored interdisciplinary head and neck rehabilitation program to usual supportive care for patients treated with concomitant chemo- or bioradiotherapy.

BACKGROUND: Since 2011, a tailored, interdisciplinary head and neck rehabilitation (IHNR) program, covered by the basic healthcare insurance, is offered to advanced head and neck cancer (HNC) patients in the Netherlands Cancer Institute (NKI). This program is developed to preserve or restore patients' functioning, and to optimize health-related quality of life (HRQoL). It applies an integrated approach to define patients' individual goals and provide rehabilitation care throughout the cancer care continuum. The aim of the current study is to assess the (cost-) effectiveness of the IHNR approach compared to usual supportive care (USC) consisting of monodisciplinary and multidisciplinary care in advanced HNC patients. METHODS: This multicenter prospective observational study is designed to compare (cost-)effectiveness of the IHNR to USC for advanced HNC patients treated with chemoradiotherapy (CRT) or bioradiotherapy (BRT). The primary outcome is HRQoL represented in the EORTC QLQ-C30 summary score. Functional HRQoL, societal participation, utility values, return to work (RTW), unmet needs (UN), patient satisfaction and clinical outcomes are secondary outcomes, assessed using the EORTC QLQ-H&N35, USER-P, EQ-5D-5 L, and study-specific questionnaires, respectively. Both patient groups (required sample size: 64 per arm) are requested to complete the questionnaires at: diagnosis (baseline; T0), 3 months (T1), 6 months (T2), 9 months (T3) and 12 months (T4) after start of medical treatment. Differences in outcomes between the intervention and control group will be analyzed using mixed effects models, Chi-square test and descriptive statistics. In addition, a cost-effectiveness analysis (CEA) will be performed by means of a Markov decision model. The CEA will be performed using a societal perspective of the Netherlands. DISCUSSION: This prospective multicenter study will provide evidence on the effectiveness and cost-effectiveness of IHNR compared to USC. RTW and societal participation, included as secondary outcomes, have not been studied sufficiently yet in cancer rehabilitation. Interdisciplinary rehabilitation has not yet been implemented as usual care in all centers, which offers the opportunity to perform a controlled clinical study. If demonstrated to be (cost-)effective, national provision of the program can probably be advised. TRIAL REGISTRATION: The study has been retrospectively registered in the Netherlands Trial Registry on April 24th 2018 ( NTR7140 ).

Unmet supportive care needs in patients treated with total laryngectomy and its associated factors.

BACKGROUND: The purpose of this study was to investigate unmet supportive care needs in patients treated with total laryngectomy and its associated factors. METHODS: In this cross-sectional study, 283 patients who underwent total laryngectomy completed questions on supportive care needs (Supportive Care Needs Survey [SCNS]). Median time since total laryngectomy surgery was 7 years (range 0-37 years). The prevalence of unmet supportive care needs and its associated factors were investigated using logistic regression analyses. RESULTS: Unmet supportive care needs were highest for the head and neck cancer-specific functioning domain (53%), followed by the psychological (39%), physical and daily living (37%), health system, information, and patient support (35%), sexuality (23%), and lifestyle (5%) domains. Seventy-one percent reported at least one low, moderate, or high unmet need. Female sex, living alone, and having a voice prosthesis were positively associated with unmet needs on 1 domain (P < .05). A worse health-related quality of life was associated with unmet needs on all domains. CONCLUSION: The majority of patients who underwent total laryngectomy report at least one low, moderate, or high unmet supportive care need.

Home-based telehealth service for swallowing and nutrition management following head and neck cancer treatment.

Introduction Following (chemo)radiotherapy (C/RT) for head and neck cancer (HNC), patients return to hospital for regular outpatient reviews with speech pathology (SP) and nutrition and dietetics (ND) for acute symptom monitoring, nutritional management, and swallowing and communication rehabilitation. The aim of the current study was to determine the feasibility of a home-based telehealth model for delivering SP and ND reviews, to provide patients with more convenient access to these appointments. Methods Service outcomes, costs, and consumer satisfaction were examined across 30 matched participants: 15 supported via the standard model of care (SMOC), and 15 via the home-based telehealth model of care (TMOC). Results All patients were successfully managed via telehealth. The TMOC was more efficient, with a reduced number ( p < 0.003) and duration ( p < 0.01) of appointments required until discharge. Significant patient cost savings ( p = 0.002) were reported for the TMOC due to decreased travel requirements. While staff costs were reduced, additional telehealth equipment levies resulted in a lower but non-significant overall cost difference to the health service when using the TMOC. High satisfaction was reported by all participants attending the TMOC. Discussion The findings support the feasibility of a home-based telehealth model for conducting SP and ND reviews post C/RT for HNC.

Maximizing Functional Outcomes in Head and Neck Cancer Survivors: Assessment and Rehabilitation.

With increases in survivorship for patients with head and neck cancer, attention is turning to quality-of-life issues for survivors. Care for these patients is multifaceted. Dysphagia and issues of voice/speech, airway obstruction, neck and shoulder dysfunction, lymphedema, and pain control are important to address. Rehabilitation interventions are patient-specific and aim to prevent, restore, compensate, and palliate symptoms and sequelae of treatment for optimal functioning. Central to providing comprehensive interdisciplinary care are the head and neck surgeon, laryngologist, and speech-language pathologist. Routine functional assessment, long-term follow-up, and regular communication and coordination among these specialists helps maximize quality of life in this challenging patient population.

Investigation of nutritional status using the Mini Nutritional Assessment-Short Form and analysis of the relevant factors in patients with head and neck tumour.

OBJECTIVE: The aims of this study were to reveal the nutritional status of patients after head and neck tumour treatment by using the Mini Nutritional Assessment-Short Form (MNA-SF) and to analyse the factors affecting nutritional status in patients with head and neck tumour. BACKGROUND: Elderly patients with loss of teeth and maxillary/mandibular bone due to head and neck tumour treatment could be at high risk of malnutrition. However, there are few reports on the nutritional status of these patients. MATERIALS AND METHODS: Forty-six participants (average age 74.7 years) were selected from patients who visited the maxillofacial prosthetics clinic of Tokyo Medical and Dental University Hospital Faculty of Dentistry in Japan. Nutritional status was evaluated using the MNA-SF. Multiple regression analysis was used to identify predictors affecting MNA-SF score. The candidate explanatory variables were age, sex, maxillofacial prosthesis use, number of residual teeth, resection side, neck dissection and treatment option. RESULTS: The results showed that approximately half of the patients were at risk of malnutrition, and a regression equation for MNA-SF score was developed using two predictors: maxillofacial prosthesis use and neck dissection. CONCLUSION: Use of a maxillofacial prosthesis can improve nutritional status. On the other hand, a medical history of neck dissection can decrease nutritional status.

The development of an ICF-based clinical guideline and screening tool for the standardized assessment and evaluation of functioning after head and neck cancer treatment.

The assessment and evaluation of functioning and quality of life after tumor treatment in head and neck cancer (HNC) are considered as essential aspects of clinical routine and studies. A huge number of instruments are available that have been designed to evaluate functioning and quality of life after HNC treatment. The diversity of these instruments in terms of content, response options and administration hinders the comparability of available studies and the performance of meta-analyses. The objective of this paper is to inform about the development of a screening tool for the standardized assessment and evaluation of functioning based on the International Classification of Functioning, Disability and Health (ICF) Core Set for HNC. We followed a multi-step approach including (1) preparatory studies to identify and preselect suitable instruments for the assessment of functioning, (2) a decision-making process to agree on an ICF-based clinical guideline including instruments assessing functioning and (3) the development of a computer-based standardized screening tool to assess and evaluate functioning based on this guideline in clinical routine. Twenty-one experts participated in a consensus meeting and decided on instruments to be included in an ICF-based clinical guideline and screening tool for the assessment and evaluation of functioning in HNC patients in cancer treatment. The chosen instruments cover all aspects of the ICF Core Set for HNC addressing therapy control, pain, food intake/swallowing, voice/speech/breathing, other somatic complaints and psychosocial aspects. The screening tool contains patient-reported outcome measures and a clinician's checklist. It has to be further tested in clinical practice.

Vulnerable characteristics and interest in wellness programs among head and neck cancer caregivers.

PURPOSE: Head and neck cancer (HNC) caregivers have poorer psychological health compared to patients and the general population but have not yet been targeted for wellness programs to reduce adverse psychosocial or physical health outcomes. To inform development of such programs, we identified potential vulnerabilities to poor outcomes and examined wellness program preferences among HNC caregivers. We also examined whether interest in wellness programs varied by potential vulnerabilities among HNC caregivers. METHODS: Surveys were administered to caregivers (n = 33) of HNC patients undergoing major surgery. Sociodemographic factors, caregiving characteristics, psychosocial functioning, and health behavior data were collected. Fisher's exact tests and t tests were used to examine characteristics associated with interest in the different types of wellness programs. RESULTS: Many caregivers reported a heavy caregiving load (88 % live with patient and 73 % provide daily care), a smoking history (42 %), and compromised psychosocial functioning (45 % with depressive symptoms and 33 % with anxiety above population norms). Most caregivers were interested in wellness programs focused on diet/exercise (71.9 %); cancer education (66.7 %); stress reduction (63.6 %); and finances, caregiving, and well-being (57.6 %). Caregivers endorsed highest interest in programs offered during the patient's medical treatment (63.6 %), and mail was the preferred program format (50.0 %). Those with more depressive symptoms reported more interest in programs focused on cancer education (p = 0.03); stress reduction (p = 0.05); and educational classes on finances, caregiving, and well-being (p = 0.01). CONCLUSIONS: Wellness programs offering a menu of options should be developed for HNC caregivers.

Third-party disability in carers of people with dysphagia following non-surgical management for head and neck cancer.

PURPOSE: Third-party disability pertains to the consequences of a person's impairment which impacts on the functioning and ability of their family members or significant others. With the emergence of research demonstrating the pervasive effects of dysphagia following head and neck cancer (HNC) on the carer, the aim of this study was to identify the International Classification of Functioning, Disability and Health (ICF) domains and categories that describe the third-party disability of carers of people with dysphagia following HNC. METHOD: Twelve carers of people with dysphagia following HNC participated in individual semi-structured, in-depth interviews. Categories and sub-categories identified from the qualitative analysis were mapped to the ICF using the established linking rules. RESULTS: The majority of the categories and sub-categories from the qualitative analysis were successfully linked to the ICF with most linking to the Activities and Participation component. A number of contextual factors were also identified as impacting on the functioning of carers. CONCLUSIONS: The ICF can be successfully used to describe the third-party disability in carers of people with dysphagia following HNC management. This information could be used by clinicians, researchers and policy makers to help establish evidence-based guidelines that include carers in the assessment and management of dysphagia associated with HNC. IMPLICATIONS FOR REHABILITATION: Clinical levels of distress and reduced quality of life have been associated with caring for a person with dysphagia following head and neck cancer. The flow-on effects of dysphagia experienced by a carer or close family member can be understood as a third-party disability, which impacts on their functioning, activities and participation in the context of the environment and personal factors. Using the ICF to describe the indirect effects of dysphagia on the carer may help to guide the assessment and support of this population, and advocate for the inclusion of the concerns of the carer in dysphagia management.

Productivity Losses Associated with Head and Neck Cancer Using the Human Capital and Friction Cost Approaches.

OBJECTIVES: Previous studies suggest that productivity losses associated with head and neck cancer (HNC) are higher than in other cancers. These studies have only assessed a single aspect of productivity loss, such as temporary absenteeism or premature mortality, and have only used the Human Capital Approach (HCA). The Friction Cost Approach (FCA) is increasingly recommended, although has not previously been used to assess lost production from HNC. The aim of this study was to estimate the lost productivity associated with HNC due to different types of absenteeism and premature mortality, using both the HCA and FCA. METHODS: Survey data on employment status were collected from 251 HNC survivors in Ireland and combined with population-level survival estimates and national wage data. The cost of temporary and permanent time off work, reduced working hours and premature mortality using both the HCA and FCA were calculated. RESULTS: Estimated total productivity losses per employed person of working age were EUR253,800 using HCA and EUR6800 using FCA. The main driver of HCA costs was premature mortality (38% of total) while for FCA it was temporary time off (73% of total). CONCLUSIONS: The productivity losses associated with head and neck cancer are substantial, and return to work assistance could form an important part of rehabilitation. Use of both the HCA and FCA approaches allowed different drivers of productivity losses to be identified, due to the different assumptions of the two methods. For future estimates of productivity losses, the use of both approaches may be pragmatic.

A national survey of healthcare professionals' views on models of follow-up, holistic needs assessment and survivorship care for patients with head and neck cancer.

Patterns of follow-up and survivorship care are changing in response to growing numbers of cancer survivors and an increasing recognition that traditional models are unsustainable and result in unmet needs. Clinicians have shown reluctance in changing conventional follow-up practices for patients with head and neck cancer. This study aimed to explore nurses' and allied health professionals' views and practices in relation to follow-up, holistic needs assessment and survivorship care in this patient group. An online survey of members of the British Association of Head and Neck Oncology Nurses was undertaken. The response rate was 43% (74 of 174). Findings revealed a range of existing models of follow-up, rehabilitation and support for people with head and neck cancer across the UK. Specialist staff were open to new models of care and to more responsibility, with adequate training and supervision. There were some gaps in the provision of comprehensive survivorship care and some specific areas of practice in which nurses lacked confidence, knowledge and skills, such as managing medications and complex symptoms. Further research is needed to develop and evaluate effective models of follow-up and support for a growing population of head and neck cancer survivors who have diverse and complex needs.

Quality of life in head and neck cancer survivors at 1 year after treatment: the mediating role of unmet supportive care needs.

PURPOSE: The aim of the study was to test a hypothesised model that supportive care needs (SCNs) have a mediating effect on the relationship between characteristics of (Chinese) head and neck cancer (HNC) survivors and their quality of life (QoL). METHODS: A total of 285 Chinese HNC survivors who had finished cancer treatment 1 year earlier completed a self-reported survey covering demographic and clinical characteristics, the Chinese version of the Short-Form Supportive Care Needs Questionnaire (SCNS-SF34-C), the supplementary module of access to healthcare and ancillary support services and the Functional Assessment of Cancer Therapy for Head and Neck Cancer (FACT-H&N). RESULTS: The final path model showed that optimism, educational level, any coexisting disease, number of somatic symptoms, household income, eating ability, support from others, whether the cancer is under control or not and travelling time from home to hospital have direct or indirect effects, or both, on the QoL of HNC survivors, by way of unmet SCNs in the psychological, physical and/or health system information domains, which account for 64 % of the variance in the total FACT-H&N score. CONCLUSIONS: Our study demonstrated the mediating effects of SCNs in the association between HNC survivors and their QoL. Early needs assessment may help healthcare professionals to identify the actual needs of these survivors, and providing the information that HNC survivors want is a significant factor in meeting their psychological needs and thereby improving their overall QoL.

Implant-retained dental rehabilitation in head and neck cancer patients: an assessment of success and failure.

BACKGROUND: This study aimed to evaluate the rate of osseointegration (ROI) and overall success rate (OSR) of implants placed in native and grafted jaws with or without radiotherapy at a 5-year follow-up in Indian head and neck cancer patients. MATERIAL AND METHODS: Thirty head and neck cancer patients from various socioeconomic strata were accrued. Eighty-five implants were inserted in 17 native and 13 grafted jaws. Nineteen patients received radiation therapy. A 5-year follow-up ROI and OSR of implants were reported. RESULTS: The 5-year ROI and OSR were 88% and 77%, respectively. ROI was 93% for grafted, 85% for native, 83% for irradiated, and 100% for nonirradiated jaws. OSR was 73% for grafted, 80% for native, 71% for irradiated, and 89% for nonirradiated jaws. Patients from higher socioeconomic strata had higher OSR (92%) as compared with those belonging to lower socioeconomic strata (65%). CONCLUSION: The failure rate observed in this study was 24% for implants placed in head and neck cancer patients at a 5-year follow-up.

Provision of surgical voice restoration in England: questionnaire survey of speech and language therapists.

AIM: To conduct a questionnaire survey of speech and language therapists providing and managing surgical voice restoration in England. METHOD: National Health Service Trusts registering more than 10 new laryngeal cancer patients during any one year, from November 2009 to October 2010, were identified, and a list of speech and language therapists compiled. A questionnaire was developed, peer reviewed and revised. The final questionnaire was e-mailed with a covering letter to 82 units. RESULTS: Eighty-two questionnaires were distributed and 72 were returned and analysed, giving a response rate of 87.8 per cent. Forty-four per cent (38/59) of the units performed more than 10 laryngectomies per year. An in-hours surgical voice restoration service was provided by speech and language therapists in 45.8 per cent (33/72) and assisted by nurses in 34.7 per cent (25/72). An out of hours service was provided directly by ENT staff in 35.5 per cent (21/59). Eighty-eight per cent (63/72) of units reported less than 10 (emergency) out of hours calls per month. CONCLUSION: Surgical voice restoration service provision varies within and between cancer networks. There is a need for a national management and care protocol, an educational programme for out of hours service providers, and a review of current speech and language therapist staffing levels in England.

The need for versatility in the prosthodontic treatment of maxillofacial defects.

The main objective of this study was to survey the different maxillofacial defects of patients who presented to the Wits Dental Hospital and to review the methods that have been used to rehabilitate these patients. Forty six patient records were retrieved from patients' files and from final year reports of prosthodontic postgraduate students. The data were used to determine the type of maxillofacial defects that these patients suffered from and the treatment that had been carried out. Duration and cost of treatment was also noted. The study showed that the majority of the patients' defects were caused by cancer resections, followed by trauma, clefts, burns, and infection. Most patients received conventional 'appropriatech' treatments such as the use of adhesive-retained prostheses, whilst a small number received more sophisticated 'high tech' treatments of implant rehabilitation. The need for versatility in the prosthodontic treatment of maxillofacial defects.

Prosthodontic rehabilitation of oral function in head-neck cancer patients with dental implants placed simultaneously during ablative tumour surgery: an assessment of treatment outcomes and quality of life.

The aim of this prospective study was to assess treatment outcome and impact on quality of life of prosthodontic rehabilitation with implant-retained prostheses in head-neck cancer patients. Fifty patients were evaluated by standardized questionnaires and clinical assessment. All received the implants during ablative tumour surgery in native bone in the interforaminal area. About two-thirds of the patients (n=31) needed radiotherapy post-surgery. Both in irradiated and non-irradiated bone two implants were lost 18-24 months after installation. Peri-implant tissues had a healthy appearance. No cases of osteoradionecrosis occurred. In 15 patients no functional implant-retained lower dentures could be made for various reasons. The other 35 patients all functioned well, with an improvement in quality of life. Major improvement was observed in the non-irradiated patients. In the irradiated patients, less improvement in many functional items was observed, while items related to the oral sequelae of radiotherapy did not improve. Similar to the quality-of-life assessments, denture satisfaction was improved and tended to be higher in non-irradiated than irradiated patients. Implant-retained lower dentures can substantially improve the quality of life related to oral functioning and denture satisfaction in head-neck cancer patients. This effect is greater in non-irradiated than irradiated cancer patients.

Follow-up quality of life assessment in patients after head and neck surgery as evaluated by lay caregivers.

OBJECTIVE/HYPOTHESIS: As rehabilitation after head and neck surgery is increasingly dependent upon caregivers with no formal training (lay caregivers), the lay caregiver's assessment of the patient's quality of life (QOL) status may be critical to successful rehabilitative efforts. This study evaluates lay caregiver QOL assessment at six and 12 months post-operatively and compares the findings to pre-operative assessments. MATERIALS AND METHODS: Twenty-five patients undergoing head and neck surgery and their primary lay caregivers completed the Medical Outcomes Survey Short Form 36 (SF-36) pre-operatively and were followed. Six and 12-month post-operative forms were completed and compared for available patient/lay caregiver pairs. Pair assessment was considered congruent if the lay caregiver's assessment of each domain of the SF-36 fell within the 90th % confidence interval of the patient's score. High congruence was defined as congruence between the pairs for six or more of the eight domains. Results were also related to previously published preoperative data. RESULTS: Fourteen and six patient/lay caregiver pairs completed the six and 12-month follow-up forms, respectively. Overall congruence was 55% and 45% at six and 12 months, respectively, down from 70% found pre-operatively. Forty-two percent and 17% of the patient/lay caregiver pairs were highly congruent at six and 12 months, respectively. Both values were below the 60% high congruence value noted pre-operatively. The trend toward lay caregivers underrating general health was maintained, while overrating of bodily pain leveled at six months and returned at 12 months. Same generation pairs demonstrated a steady decrease in high congruence levels at six and 12 months. Recurrent disease status no longer predicted high congruence at six or 12 months. CONCLUSION: Trends predicting high congruence in patient/lay caregiver QOL assessment identified preoperatively were not maintained in the post-operative evaluations, except the underrating of patients' general health status. Lay caregiver ability to accurately assess patient QOL status did not improve and, in fact, appeared to worsen. Further study into lay caregiver assessment of patients' quality of life status following head and neck surgery is warranted. Efforts should be directed toward the use of standardized assessment tools and anticipation of subject dropout with greater subject recruitment.

Extraoral maxillofacial prosthetic rehabilitation at the M. D. Anderson Cancer Center: a survey of patient attitudes and opinions.

STATEMENT OF PROBLEM: Measures of satisfaction after extraoral maxillofacial prosthetic rehabilitation have been sparsely reported. PURPOSE: This article reviews the care-related opinions of patients who were provided extraoral prostheses at the M. D. Anderson Cancer Center over the course of 10 years. MATERIAL AND METHODS: A questionnaire was delivered to 263 extraoral prosthetic patients to elucidate their degree of satisfaction with several parameters, including prosthetic use, care, quality, durability, longevity, and cost. In addition, issues relating to self-image, socialization frequency, and income-earning ability before and after rehabilitation were surveyed. RESULTS: The views of 76 respondents demonstrated a general satisfaction with their prostheses. A majority believed that their prostheses fit comfortably, and most were satisfied with cosmesis. In addition, a preponderance of respondents reported no substantial alteration in social activity after rehabilitation. Although the number of respondents relying on their own employment fell by more than 50% after rehabilitation, nearly all reported a relatively static income before and after rehabilitation. CONCLUSION: The survey revealed a high degree of patient satisfaction with extraoral maxillofacial prostheses. Nevertheless, areas of potential improvement were not lost on the survey's population. The patients desired prostheses that last longer and have improved color stability. An interest in improved retentive mechanisms was mentioned by several patients, and only about half of the respondents perceived prosthetic cost to be completely reasonable.

Evolution of quality of life assessment in head and neck cancer.

Quality of life assessment as part of clinical practice in head and neck oncology began over 40 years ago. Early studies were narrative and cross-sectional; these were followed, at first, by simple quantitative measures of various parameters and later by longitudinal studies of greater complexity. More recently quality of life has been employed in a randomized clinical trial of head and neck cancer. Quality of life has evolved to become a standard means of assessing clinical outcomes, and an accepted end point measurement in clinical trials, to be considered alongside survivorship and side effects/complications.

The provision of hospital maxillo-facial prosthetic services in Scotland.

Maxillo-facial prosthetics can contribute much to the quality of life of patients with congenital problems or those treated surgically for a head and neck neoplasm. The availability of an adequate service varies internationally. The present study examines the current provision and requirements for such a service in Scotland. A questionnaire survey of 90 oral, plastic and ENT surgeons was carried out. Information was sought on numbers and types of cases seen, prosthetic treatment provided and involvement of Consultants in Restorative Dentistry in their management. The results show that most surgeons only treat a small number of such patients with a consequent dilution of experience, and with a possible need for supra-regional specialist centres. In addition there is a need for improvement of multi-disciplinary planning clinics for such cases.