Expectations and Experiences of Participating in a Supervised and Home-Based Physical Exercise Intervention in Patients with Head and Neck Cancer during Chemoradiotherapy: A Qualitative Study.

(1) Background: Chemoradiotherapy (CRT) for head and neck cancer (HNC) is associated with severe toxicity resulting in fatigue and weight loss, including loss of skeletal muscle mass. Exercise interventions might positively affect physical fitness and quality of life. Sufficient adherence and compliance rates are necessary for optimal effects. This study aimed to gain insight into expectations and experiences and factors influencing adherence, retention and compliance of HNC patients participating in exercise intervention during CRT. (2) Methods: Consecutive participants were invited for semi-structured interviews, conducted pre- and post-intervention. A deductive approach was used to identify themes and factors influencing adherence, retention and compliance. (3) Results: Thematic saturation was reached after interviewing 14 patients pre-intervention. Five themes were identified: planning and time management, treatment toxicity, motivation to exercise, exercise intervention and supervision by a physiotherapist. The intensity of the treatment schedule and treatment toxicity were important barriers. Facilitators mentioned were physical and emotional benefits, social support as well as the simplicity and home-based setting of the intervention. (4) Conclusions: A personalised approach, considering the individual facilitators and barriers of HNC patients, is important to increase adherence, retention and compliance to exercise intervention and to reap the optimal effects of the program.

Organization of head and neck cancer rehabilitation care: a national survey among healthcare professionals in Dutch head and neck cancer centers.

PURPOSE: Head and neck cancer (HNC) treatment often leads to physical and psychosocial impairments. Rehabilitation can overcome these limitations and improve quality of life. The aim of this study is to obtain an overview of rehabilitation care for HNC, and to investigate factors influencing rehabilitation provision, in Dutch HNC centers, and to some extent compare it to other countries. METHODS: An online survey, covering five themes: organizational structure; rehabilitation interventions; financing; barriers and facilitators; satisfaction and future improvements, among HNC healthcare- and financial professionals of Dutch HNC centers. RESULTS: Most centers (86%) applied some type of rehabilitation care, with variations in organizational structure. A speech language therapist, physiotherapist and dietitian were available in all centers, but other rehabilitation healthcare professionals in less than 60%. Facilitators for providing rehabilitation services included availability of a contact person, and positive attitude, motivation, and expertise of healthcare professionals. Barriers were lack of reimbursement, and patient related barriers including comorbidity, travel (time), low health literacy, limited financial capacity, and poor motivation. CONCLUSION: Although all HNC centers included offer rehabilitation services, there is substantial practice variation, both nationally and internationally. Factors influencing rehabilitation are related to the motivation and expertise of the treatment team, but also to reimbursement aspects and patient related factors. More research is needed to investigate the extent to which practice variation impacts individual patient outcomes and how to integrate HNC rehabilitation into routine clinical pathways.

Dutch translation and validation of the Communicative Participation Item Bank (CPIB)-short form.

BACKGROUND: Several conditions and diseases can result in speech problems that can have a negative impact on everyday functioning, referred to as communicative participation. Subjective problems with acquired speech problems are often assessed with the speech handicap index (SHI). To assess generic participation problems, the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P) questionnaire is frequently used. The English questionnaire Communicative Participation Item Bank-short form (CPIB short form) is a 10-item valid, reliable instrument that assesses communicative participation. In the absence of a Dutch equivalent, translation and validation of the CPIB short form was required. AIMS: To translate the CPIB short form into Dutch, and to determine its psychometric properties for the group of adults with speech problems resulting from a neurological aetiology or head and neck cancer. METHODS & PROCEDURES: Translation of the CPIB short form was performed following the instructions of the European Organisation for Research and Treatment for Cancer (EORTC). In a cross-sectional multi-centre study, participants completed the Dutch CPIB short form together with the SHI and USER-P, and the CPIB a second time after 2 weeks. We assessed internal consistency and test-retest reliability of the CPIB. Construct validity was assessed based on correlations with SHI, USER-P and speech assessments. OUTCOMES & RESULTS: In the validation study, 122 participants were included: 51 with dysarthria due to different neurological disorders, 48 with speech problems due to head and neck cancer treatment and 23 healthy controls. Internal consistency of the items was high (Cronbach's alpha = 0.962), the intraclass correlation coefficient (ICC) for test-retest reliability was high 0.908 (95% CI = 0.870-0.935). Construct validity was supported by a strong correlation between the Dutch CPIB short form and the SHI total score (SHI total rs = 0.887) and a moderate correlation between the Dutch CPIB-10 and the USER-P subscales (USER-P Frequency rs = 0.365; USER-P restrictions and USER-P satisfaction rs = 0.546). A moderate correlation was found between the Dutch CPIB-10 and the speech performance assessments (degree of distortedness r = -0.0557; p ≤ 0.001; degree of intelligibility r = 0.0562). CONCLUSIONS & IMPLICATIONS: The Dutch CPIB short form provides a valid and reliable tool for clinical practice and research purposes. It allows clinicians to start using this PROM in clinical and research practice to systematically investigate the impact of the speech problems on communicative participation in a Dutch-speaking population. WHAT THIS PAPER ADDS: What is already known on the subject Communicative participation allows people to take part in life situations, but can be affected by acquired speech problems. The CPIB is a patient-reported outcome measure for the assessment of this concept. For the English language the 46-item bank and a 10-item short form is available. What this paper adds to existing knowledge This paper describes the process of translation of the CPIB short form into Dutch, and confirms its reproducibility and validity. What are the potential or actual clinical implications of this work? With this validated Dutch version of the CPIB short form available, professionals can implement this tool in clinical and research practice to systematically evaluate communicative participation.

Feasibility of a supervised and home-based tailored exercise intervention in head and neck cancer patients during chemoradiotherapy.

OBJECTIVE: Chemoradiotherapy (CRT) for head and neck cancer (HNC) is associated with high toxicity that adversely affects physical functioning, body composition, fatigue, quality of life and treatment outcomes. Exercise interventions during treatment might counteract these negative effects. We therefore assessed the feasibility of an exercise programme for HNC patients during CRT. METHODS: Forty patients were offered a tailored 10-week endurance and resistance training with supervised and home-based sessions. Feasibility endpoints were (1) adherence (main outcome): ≥60% attendance; (2) recruitment: ≥30%; (3) retention rate: ≥85% and (4) compliance rate: ≥60%. Physical performance, muscle strength, body composition, quality of life and fatigue were assessed pre- and post-intervention. RESULTS: Overall adherence was 54%. The recruitment rate was 36%, and the retention rate was 65%. Compliance to the supervised intervention protocol was 66%. Statistically significant decreases were found in mean grip strength, fat-free mass and clinically relevant deteriorations on several domains of quality of life, and fatigue subscales were found. CONCLUSION: We conclude that this exercise programme for HNC patients during CRT in its current form is feasible for only a minority of patients. We suggest adaptations to improve adherence and retention rates for a definitive multicentre trial. TRIAL REGISTRATION: This study is registered at the Netherlands Trial Register (NTR7305), 6 June 2018, retrospectively registered.

Professional patient navigation in a hospital setting: a randomized controlled trial.

PURPOSE: This study aimed to determine the effect of patient navigation on health-related quality of life, distress, self-care knowledge, self-efficacy, satisfaction, and healthcare usage. METHODS: Patients newly diagnosed with ovarian, vulvar, endometrial, melanoma stage III/IV, lung, or renal cancer were randomly assigned to either care as usual or care as usual plus consultations with a patient navigator (i.e., specially trained oncology nurse who monitors, advises, and refers patients to supportive cancer care). Measures included the EORTC-QLQ-C30, distress thermometer, and study-specific questions inspired by the Symptom-Management Self-Efficacy Scale Breast Cancer, Patient Satisfaction with Cancer Care Scale, and the Medical Consumption Questionnaire. Measures were completed before randomization (baseline) and at 1 month, 3 months, and 5 months after baseline. RESULTS: In the case of health-related quality of life, no significant difference was observed between the intervention (n = 42) and the control group (n = 47). Consumption of supportive cancer care was low for both the intervention and the control group but relatively lower for the intervention group. Also, participants who consulted the patient navigator seemed to have higher levels of self-efficacy and satisfaction. CONCLUSION: Although the intervention sorted no relevant effects on health-related quality of life, it did affect patients' experience of cancer care and self-efficacy. We recommend that patient navigators monitor and advise on unmet supportive care needs, but only in the case of high-risk patients. Furthermore, considering current and prior research, it is wise to study patient navigation using more sensitive outcome measures than health-related quality of life.

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 ).

Evaluating a professional patient navigation intervention in a supportive care setting.

PURPOSE: Unmet supportive care needs are common among cancer patients. This study evaluates a patient navigation intervention (i.e., specially trained oncology nurse who monitors, advises, and (if needed) refers patients to supportive cancer care) in terms of need, satisfaction, advice uptake, and consumption of supportive cancer care. METHODS: Using a cross-sectional design, the intervention was evaluated among healthcare professionals, patients who participated, and patients who did not participate in the intervention. All patients were newly diagnosed with breast cancer or melanoma. Data was collected through medical records and online surveys. RESULTS: In total, 1091 patients were offered patient navigation. Most of these patients (755) were willing to consult the patient navigator (PN). Approximately 90% of patients who completed both the intervention and the questionnaire (N = 120, response rate 54%) perceived the PN as valuable, accessible, and reliable. Approximately 80% of respondents who needed advice regarding nutrition (n = 67), fatigue (n = 98), emotions (n = 106), and work (n = 79) were adequately informed by the PN. Of the 120 respondents, 59 used some form of supportive cancer care. Most of the responding healthcare professionals (N = 70, response rate 45%) perceived the intervention as a valuable addition to current cancer care (n = 51) and mentioned that the PN should be available to all patients (n = 54). CONCLUSIONS: The intervention was perceived as valuable by both patients and healthcare professionals. The results may, however, been biased by the large number of patients who were omitted from participation due to logistical reasons.

Feasibility and impact of a dedicated multidisciplinary rehabilitation program on health-related quality of life in advanced head and neck cancer patients.

In an observational prospective study, feasibility and outcomes of a dedicated multidisciplinary rehabilitation program (HNR) for head and neck cancer (HNC) patients were evaluated. HRQoL was assessed before and after HNR with EORTC C30 and H&N-35 QoL questionnaires in 52 consecutive patients. Initial HRQoL scores were compared with EORTC reference scores for HNC patients and post-HNR with those available for the general healthy population. Distress was assessed before and after HNR with the distress thermometer (DT). At completion of HNR with a mean duration of 7 months, overall HRQoL was significantly improved (p < 0.001). Role, Emotional, and Social function scales and most EORTC C30 and H&N35 symptom scale items showed a statistically significant (p < 0.01) and clinically relevant improvement. Mean distress score before HNR was above the cutoff value of 5, suggesting the need for referral to rehabilitation. After completing HNR, distress decreased significantly to 3.0 (p < 0.001). HRQoL pretreatment was poorer than that of the EORTC reference HNC population, whereas at the completion of the HNR program, the HRQoL was comparable to that of the general population reference level. We conclude that a dedicated multidisciplinary HNR program is feasible and suggest that it has a positive impact on HRQoL. The multidisciplinary approach may have added value over mono-disciplinary interventions. However, our results should be judged cautiously due to the observational nature of the study.