Cost-Utility of the eHealth Application 'Oncokompas', Supporting Incurably Ill Cancer Patients to Self-Manage Their Cancer-Related Symptoms: Results of a Randomized Controlled Trial.

Evidence on the cost-effectiveness of eHealth in palliative care is scarce. Oncokompas, a fully automated behavioral intervention technology, aims to support self-management in cancer patients. This study aimed to assess the cost-utility of the eHealth application Oncokompas among incurably ill cancer patients, compared to care as usual. In this randomized controlled trial, patients were randomized into the intervention group (access to Oncokompas) or the waiting-list control group (access after three months). Healthcare costs, productivity losses, and health status were measured at baseline and three months. Intervention costs were also taken into account. Non-parametric bootstrapping with 5000 replications was used to obtain 95% confidence intervals around the incremental costs and quality-adjusted life years (QALYs). A probabilistic approach was used because of the skewness of cost data. Altogether, 138 patients completed the baseline questionnaire and were randomly assigned to the intervention group (69) or the control group (69). In the base case analysis, mean total costs and mean total effects were non-significantly lower in the intervention group (-€806 and -0.01 QALYs). The probability that the intervention was more effective and less costly was 4%, whereas the probability of being less effective and less costly was 74%. Among patients with incurable cancer, Oncokompas does not impact incremental costs and seems slightly less effective in terms of QALYs, compared to care as usual. Future research on the costs of eHealth in palliative cancer care is warranted to assess the generalizability of the findings of this study.

Psychological Problems among Head and Neck Cancer Patients in Relation to Utilization of Healthcare and Informal Care and Costs in the First Two Years after Diagnosis.

BACKGROUND: To investigate associations between psychological problems and the use of healthcare and informal care and total costs among head and neck cancer (HNC) patients. METHOD: Data were used of the NETherlands QUality of Life and Biomedical Cohort study. Anxiety and depression disorder (diagnostic interview), distress, symptoms of anxiety and depression (HADS), and fear of cancer recurrence (FCR) and cancer worry scale (CWS) were measured at baseline and at 12-month follow-up. Care use and costs (questionnaire) were measured at baseline, 3-, 6-, 12-, and 24-month follow-up. Associations between psychological problems and care use/costs were investigated using logistic and multiple regression analyses. RESULTS: Data of 558 patients were used. Distress, symptoms of anxiety or depression, FCR, and/or anxiety disorder at baseline were significantly associated with higher use of primary care, supportive care, and/or informal care (odds ratios (ORs) between 1.55 and 4.76). Symptoms of anxiety, FCR, and/or depression disorder at 12-month follow-up were significantly associated with use of primary care, supportive care, and/or informal care (ORs between 1.74 and 6.42). Distress, symptoms of anxiety, and FCR at baseline were associated with higher total costs. DISCUSSION: HNC patients with psychological problems make more use of healthcare and informal care and have higher costs. This is not the result of worse clinical outcomes.

Effectiveness, Cost-effectiveness, and Cost-Utility of a Digital Smoking Cessation Intervention for Cancer Survivors: Health Economic Evaluation and Outcomes of a Pragmatic Randomized Controlled Trial.

BACKGROUND: Smoking cessation (SC) interventions may contribute to better treatment outcomes and the general well-being of cancer survivors. OBJECTIVE: This study aims to evaluate the effectiveness, cost-effectiveness, and cost-utility of a digital interactive SC intervention compared with a noninteractive web-based information brochure for cancer survivors. METHODS: A health economic evaluation alongside a pragmatic 2-arm parallel-group randomized controlled trial was conducted with follow-ups at 3, 6, and 12 months. The study was conducted in the Netherlands over the internet from November 2016 to September 2019. The participants were Dutch adult smoking cancer survivors with the intention to quit smoking. In total, 165 participants were included and analyzed: 83 (50.3%) in the MyCourse group and 82 (49.7%) in the control group. In the intervention group, participants had access to a newly developed, digital, minimally guided SC intervention (MyCourse-Quit Smoking). Control group participants received a noninteractive web-based information brochure on SC. Both groups received unrestricted access to usual care. The primary outcome was self-reported 7-day smoking abstinence at the 6-month follow-up. Secondary outcomes were quality-adjusted life years gained, number of cigarettes smoked, nicotine dependence, and treatment satisfaction. For the health economic evaluation, intervention costs, health care costs, and costs stemming from productivity losses were assessed over a 12-month horizon. RESULTS: At the 6-month follow-up, the quit rates were 28% (23/83) and 26% (21/82) in the MyCourse and control groups, respectively (odds ratio 0.47, 95% CI 0.03-7.86; P=.60). In both groups, nicotine dependence scores were reduced at 12 months, and the number of smoked cigarettes was reduced by approximately half. The number of cigarettes decreased more over time, and the MyCourse group demonstrated a significantly greater reduction at the 12-month follow-up (incidence rate ratio 0.87; 95% CI 0.76-1.00; P=.04). Intervention costs were estimated at US $193 per participant for the MyCourse group and US $74 for the control group. The mean per-participant societal costs were US $25,329 (SD US $29,137) and US $21,836 (SD US $25,792), respectively. In the cost-utility analysis, MyCourse was not preferred over the control group from a societal perspective. With smoking behavior as the outcome, the MyCourse group led to marginally better results per reduced pack-year against higher societal costs, with a mean incremental cost-effectiveness ratio of US $52,067 (95% CI US $32,515-US $81,346). CONCLUSIONS: At 6 months, there was no evidence of a differential effect on cessation rates; in both groups, approximately a quarter of the cancer survivors quit smoking and their number of cigarettes smoked was reduced by half. At 12 months, the MyCourse intervention led to a greater reduction in the number of smoked cigarettes, albeit at higher costs than for the control group. No evidence was found for a differential effect on quality-adjusted life years. TRIAL REGISTRATION: The Netherlands Trial Register NTR6011; https://www.trialregister.nl/trial/5434. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12885-018-4206-z.

Relationship between videofluoroscopic and subjective (physician- and patient- rated) assessment of late swallowing dysfunction after (chemo) radiation: Results of a prospective observational study.

BACKGROUND AND PURPOSE: Primary (chemo)radiation (CHRT) for HNC may lead to late dysphagia. The purpose of this study was to assess the pattern of swallowing disorders based on prospectively collected objective videofluoroscopic (VF) assessment and to assess the correlations between VF findings and subjective (physician- and patient-rated) swallowing measures. MATERIAL AND METHODS: 189 consecutive HNC patients receiving (CH)RT were included. Swallowing evaluation at baseline and 6 months after treatment (T6) encompassed: CTCAE v.4.0 scores (aspiration/dysphagia), PROMs: SWAL QOL/ EORTC QLQ-H&N35 (swallowing domain) questionnaires and VF evaluation: Penetration Aspiration Scale, semi-quantitative swallowing pathophysiology evaluation, temporal measures and oral/pharyngeal residue quantification. Aspiration specific PROMs (aPROMs) were selected. Correlations between late penetration/aspiration (PA_T6) and: clinical factors, CTCAE and aPROMs were assessed using uni- and multivariable analysis. RESULTS: Prevalence of PA increased from 20% at baseline to 43% after treatment (p < 0.001). The most relevant baseline predictors for PA_T6 were: PA_T0, age, disease stage III-IV, bilateral RT and baseline aPROM 'Choking when drinking' (AUC: 0.84). In general aPROMs correlated better with VF-based PA than CTCAE scores. The most of physiological swallowing components significantly correlated and predictive for PA (i.e. Laryngeal Vestibular Closure, Laryngeal Elevation and Pharyngeal Contraction) were prone to radiation damage. CONCLUSION: The risk of RT-induced PA is substantial. Presented prediction models for late penetration/aspiration may support patient selection for baseline and follow-up VF examination. Furthermore, all aspiration related OARs involved in aforementioned swallowing components should be addressed in swallowing sparing strategies. The dose to these structures as well as baseline PROMs should be included in future NTCP models for aspiration.

Psychological problems among cancer patients in relation to healthcare and societal costs: A systematic review.

OBJECTIVE: This study systematically reviewed the association of psychological problems among cancer patients with healthcare and societal resource use and costs. METHODS: PubMed, PsycINFO, and Embase were searched (until 31 January 2021) for studies on psychological symptoms (anxiety, depression, distress, fear of recurrence) or psychiatric disorders (anxiety, depression, adjustment) and healthcare use (e.g., mental, inpatient healthcare), economic losses by patients and family, economic losses in other sectors (e.g., absence from work), and costs. The search, data extraction, and quality assessment were performed by two authors. RESULTS: Of the 4157 identified records, 49 articles were included (psychological symptoms (n = 34), psychiatric disorders (n = 14), both (n = 1)) which focused on healthcare use (n = 36), economic losses by patients and family (n = 5), economic losses in other sectors (n = 8) and/or costs (n = 13). In total, for 12 of the 94 associations strong evidence was found. Psychological symptoms and psychiatric disorders were positively associated with increased healthcare use (mental, primary, inpatient, outpatient healthcare), losses in other sectors (absence from work), and costs (inpatient, outpatient, total healthcare costs). Moderate evidence was found for a positive association between (any) psychiatric disorder and depression disorder with inpatient healthcare and medication use, respectively. CONCLUSIONS: Psychological problems in cancer patients are associated with increased healthcare use, healthcare costs and economic losses. Further research is needed on psychological problems in relation to understudied healthcare use or costs categories, productivity losses, and informal care costs.

Cost-utility and cost-effectiveness of a guided self-help head and neck exercise program for patients treated with total laryngectomy: Results of a multi-center randomized controlled trial.

OBJECTIVES: The guided self-help exercise program called In Tune without Cords (ITwC) is effective in improving swallowing problems and communication among patients treated with a total laryngectomy (TL). This study investigated the cost-utility and cost-effectiveness of ITwC. MATERIALS AND METHODS: Patients within 5 years after TL were included in this randomized controlled trial. Patients in the intervention group (n = 46) received access to the self-help exercise program with flexibility, range-of-motion and lymphedema exercises, and a self-care education program. Patients in the control group (n = 46) received access to the self-care education program only. Healthcare utilization (iMCQ), productivity losses (iPCQ), health status (EQ-5D-3L, EORTC QLU-C10D) and swallowing problems (SwalQol) were measured at baseline, 3- and 6-months follow-up. Hospital costs were extracted from medical files. Mean total costs and effects (quality-adjusted life-years (QALYs) or SwalQol score) were compared with regression analyses using bias-corrected accelerated bootstrapping. RESULTS: Mean total costs were non-significantly lower (-€685) and QALYs were significantly higher (+0.06) in the intervention compared to the control group. The probability that the intervention is less costly and more effective was 73%. Sensitivity analyses with adjustment for baseline costs and EQ-5D scores showed non-significantly higher costs (+€119 to +€364) and QALYs (+0.02 to +0.03). A sensitivity analysis using the QLU-C10D to calculate QALYs showed higher costs (+€741) and lower QALYs (-0.01) and an analysis that used the SwalQol showed higher costs (+€232) and higher effects (improvement of 6 points on a 0-100 scale). CONCLUSION: ITwC is likely to be effective, but possibly at higher expenses. TRIAL REGISTRATION: NTR5255.

Assessment of a Structured Self-Management Support Intervention by Nurses for Patients With Incurable Cancer.

OBJECTIVES: To gain an understanding of the perceptions of patients with incurable cancer regarding a new nurse-led self-management support intervention with an integrated eHealth application (Oncokompas) and its potential effectiveness. SAMPLE & SETTING: 36 patients receiving support in the home setting. METHODS & VARIABLES: A pre- and post-test mixed-methods design was used with a period of 12 weeks between the tests and qualitative interviews. Outcome measures were the perceived application of the intervention, patient satisfaction, patient activation, and quality of life. RESULTS: 85% of patients were satisfied with the assessment of their needs and the advice received. They valued nurses' expertise and the assistance provided in their homes. Twenty-five percent of the patients used Oncokompas. However, no statistically significant changes in patient activation and quality of life were found. IMPLICATIONS FOR NURSING: This intervention can be used for encouraging self-management by patients with incurable cancer. Additional refinement and tailoring is desirable. Offering the intervention as early in the palliative phase as possible is recommended.

Healthcare utilization and productivity loss in glioma patients and family caregivers: the impact of treatable psychological symptoms.

BACKGROUND: Gliomas are associated with significant healthcare burden, yet reports of costs are scarce. While many costs are unavoidable there may be treatable symptoms contributing to higher costs. We describe healthcare and societal costs in glioma patients at high risk for depression and their family caregivers, and explore relationships between costs and treatable symptoms. METHODS: Data from a multicenter randomized trial on effects of internet-based therapy for depressive symptoms were used (NTR3223). Costs of self-reported healthcare utilization, medication use, and productivity loss were calculated for patients and caregivers separately. We used generalized linear regression models to predict costs with depressive symptoms, fatigue, cognitive complaints, tumor grade (low-/high-grade), disease status (stable or active/progression), and intervention (use/non-use) as predictors. RESULTS: Multiple assessments from baseline through 12 months from 91 glioma patients and 46 caregivers were used. Mean overall costs per year were M = €20,587.53 (sd = €30,910.53) for patients and M = €5,581.49 (sd = €13,102.82) for caregivers. In patients, higher healthcare utilization costs were associated with more depressive symptoms; higher medication costs were associated with active/progressive disease. In caregivers, higher overall costs were linked with increased caregiver fatigue, cognitive complaints, and lower patient tumor grade. Higher healthcare utilization costs were related to more cognitive complaints and lower tumor grade. More productivity loss costs were associated with increased fatigue (all P < 0.05). CONCLUSIONS: There are substantial healthcare and societal costs for glioma patients and caregivers. Associations between costs and treatable psychological symptoms indicate that possibly, adequate support could decrease costs. TRIAL REGISTRATION: Netherlands Trial Register NTR3223.

Efficacy and cost-utility of the eHealth self-management application 'Oncokompas', helping partners of patients with incurable cancer to identify their unmet supportive care needs and to take actions to meet their needs: a study protocol of a randomized controlled trial.

BACKGROUND: Incurable cancer does not only affect patients, it also affects the lives of their partners. Many partners take on caregiving responsibilities. The burden of these caregiving tasks are often associated with physical, psychological, and social difficulties and many partners have unmet supportive care needs. Oncokompas is an eHealth self-management application to support partners in finding and obtaining optimal supportive care, tailored to their quality of life and personal preferences. A randomized controlled trial will be carried out to determine the efficacy and cost-utility of Oncokompas. METHODS: A total of 136 adult partners of patients with incurable cancer will be included. Partners will be randomly assigned to the intervention group, which directly gets access to Oncokompas, or the waiting-list control group, which gets access to Oncokompas after three months. The primary outcome measure is caregiver burden. Secondary outcome measures comprise self-efficacy, health-related quality of life, and costs. Measures will be assessed at baseline, two weeks after randomization, and three months after the baseline measurement. DISCUSSION: This study will result in evidence on the efficacy and cost-utility of Oncokompas among partners of patients with incurable cancer, which might lead to implementation of Oncokompas as a health service for partners of patients with incurable cancer. TRIAL REGISTRATION: Netherlands Trial Register, NTR 7636. Registered on 23 November 2018.

Prevalence of adjustment disorder among cancer patients, and the reach, effectiveness, cost-utility and budget impact of tailored psychological treatment: study protocol of a randomized controlled trial.

BACKGROUND: Information on the prevalence of adjustment disorders among cancer patients and the value of psychological interventions in this group of patients is limited. This study investigates the prevalence of adjustment disorders among cancer patients as well as the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention. METHOD: This study consists of two parts. Part 1 is an observational study among a representative group of mixed cancer patients after cancer treatment on the prevalence of adjustment disorder as well as the uptake (i.e. reach) of psychological treatment. In Part 2, patients diagnosed with an adjustment disorder are invited to participate in a randomized controlled trial. Patients will be randomized to the intervention (access to the tailored psychological intervention) or control group (waitlist period of 6 months). The psychological intervention consists of three modules: one module containing psycho-education (3 sessions, all patients) and two additional modules (maximum of 6 sessions per module) provided as continuum, in case needed. Module 2 and 3 can consist of several evidence-based interventions (e.g. group interventions, mindfulness, eHealth) The primary outcome is psychological distress (HADS). Secondary outcomes are mental adjustment to cancer (MAC) and health-related quality of life (EORTC QLQ-C30). To assess the cost-utility and budget impact, quality of life (EQ-5D-5 L) and costs (iMCQ and iPCQ) will be measured. Measures will be completed at baseline and 3 and 6-months after randomization. DISCUSSION: This study will provide data of the prevalence of adjustment disorders and the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention. TRIAL REGISTRATION: Netherlands Trial Register identifier: NL7763. Registered on 3 June 2019.

Efficacy and cost-utility of the eHealth application 'Oncokompas', supporting patients with incurable cancer in finding optimal palliative care, tailored to their quality of life and personal preferences: a study protocol of a randomized controlled trial.

BACKGROUND: Patients with incurable cancer have to deal with a wide range of symptoms due to their disease and treatment, influencing their quality of life. Nowadays, patients are expected to adopt an active role in managing their own health and healthcare. Oncokompas is an eHealth self-management application developed to support patients in finding optimal palliative care, tailored to their quality of life and personal preferences. A randomized controlled trial will be carried out to determine the efficacy and cost-utility of Oncokompas compared to care as usual. METHODS: 136 adult patients with incurable lung, breast, colorectal and head and neck cancer, lymphoma and glioma, will be included. Eligible patients have no curative treatment options and a prognosis of at least three months. Patients will be randomly assigned to the intervention group or the control group. The intervention group directly has access to Oncokompas alongside care as usual, while the waiting list control group receives care as usual and will have access to Oncokompas after three months. The primary outcome measure is patient activation, which can be described as a patient's knowledge, skills and confidence to manage his or her own health and healthcare. Secondary outcome measures comprise self-efficacy, health-related quality of life, and costs. Measures will be assessed at baseline, two weeks after randomization, and three months after the baseline measurement. DISCUSSION: This study will result in knowledge on the efficacy and cost-utility of Oncokompas among patients with incurable cancer. Also, more knowledge will be generated into the need for and costs of palliative care from a societal and healthcare perspective. TRIAL REGISTRATION: Netherlands Trial Register identifier: NTR 7494 . Registered on 24 September 2018.

Assessment of Neurocognitive Impairment and Speech Functioning Before Head and Neck Cancer Treatment.

Importance: Head and neck cancer (HNC) and its treatment may negatively alter neurocognitive and speech functioning. However, the prevalence of neurocognitive impairment among patients with HNC before treatment is poorly studied, and the association between neurocognitive and speech functioning is unknown, which hampers good interpretability of the effect of HNC treatment on neurocognitive and speech function. Objectives: To document neurocognitive functioning in patients with HNC before treatment and to investigate the association between neurocognitive and speech functioning. Design, Setting, and Participants: Prospective cohort study of newly diagnosed patients with HNC before treatment using a large sample obtained in a nationwide, multicenter setting (Netherlands Quality of Life and Biomedical Cohort Study in Head and Neck Cancer [NET-QUBIC] project). Main Outcome and Measures: Objective neuropsychological measures of delayed recall, letter fluency, and executive functioning, as well as patient-reported outcome measures on neurocognitive speech and functioning, were collected before treatment. Results: In total, 254 patients with HNC participated (71.7% male), with a mean (SD) age of 62 (10) years. The response rate ranged from 81.9% (208 of 254) to 84.6% (215 of 254). Objective neurocognitive measures indicated that 4.7% (10 of 212) to 15.0% (32 of 214) of patients were initially seen with moderate to severe cognitive impairment. Mild to moderate impairment was found in 12.3% (26 of 212) to 26.2% (56 of 214) of patients. The most altered domains were delayed recall and letter fluency. Seven percent (15 of 208) of the patients reported high levels of everyday neurocognitive failure, and 42.6% (89 of 209) reported speech problems. Objective neurocognitive function was not significantly associated with patient-reported neurocognitive or speech functioning, but the results from patient-reported outcome measures were significantly correlated. Conclusions and Relevance: Results of this study demonstrate a high prevalence of impaired speech functioning among patients with HNC before treatment, which is in line with previous findings. A novel finding is that neurocognitive impairment is also highly prevalent as objectively measured and as self-perceived. Understanding the reason why patients with HNC are initially seen with neurocognitive impairment before the start of treatment is important because this impairment may complicate patient-clinician interaction and alter treatment adherence and because treatment itself may further worsen cognitive functioning. In addition, low self-perceived neurocognitive and speech functioning before treatment may decrease a patient's confidence in communicative participation and perceived quality of life. Disentangling the associations between objective and patient-reported neurocognitive and speech functions is an important area for future research.

The EORTC CAT Core-The computer adaptive version of the EORTC QLQ-C30 questionnaire.

BACKGROUND: To optimise measurement precision, relevance to patients and flexibility, patient-reported outcome measures (PROMs) should ideally be adapted to the individual patient/study while retaining direct comparability of scores across patients/studies. This is achievable using item banks and computerised adaptive tests (CATs). The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) is one of the most widely used PROMs in cancer research and clinical practice. Here we provide an overview of the research program to develop CAT versions of the QLQ-C30's 14 functional and symptom domains. METHODS: The EORTC Quality of Life Group's strategy for developing CAT item banks consists of: literature search to identify potential candidate items; formulation of new items compatible with the QLQ-C30 item style; expert evaluations and patient interviews; field-testing and psychometric analyses, including factor analysis, item response theory calibration and simulation of measurement properties. In addition, software for setting up, running and scoring CAT has been developed. RESULTS: Across eight rounds of data collections, 9782 patients were recruited from 12 countries for the field-testing. The four phases of development resulted in a total of 260 unique items across the 14 domains. Each item bank consists of 7-34 items. Psychometric evaluations indicated higher measurement precision and increased statistical power of the CAT measures compared to the QLQ-C30 scales. Using CAT, sample size requirements may be reduced by approximately 20-35% on average without loss of power. CONCLUSIONS: The EORTC CAT Core represents a more precise, powerful and flexible measurement system than the QLQ-C30. It is currently being validated in a large independent, international sample of cancer patients.

Cost-utility analysis of meaning-centered group psychotherapy for cancer survivors.

BACKGROUND: Meaning-centered group psychotherapy for cancer survivors (MCGP-CS) improves meaning, psychological well-being, and mental adjustment to cancer and reduces psychological distress. This randomized controlled trial was conducted to investigate the cost-utility of MCGP-CS compared with supportive group psychotherapy (SGP) and care-as-usual (CAU). METHODS: In total, 170 patients were randomized to MCGP-CS, SGP, or CAU. Intervention costs, direct medical and nonmedical costs, productivity losses, and health-related quality of life were measured until 6 months follow-up, using the TIC-P, PRODISQ, data from the hospital information system, and the EQ-5D. The cost-utility was calculated by comparing mean cumulative costs and quality-adjusted life years (QALYs). RESULTS: Mean total costs ranged from €4492 (MCGP-CS) to €5304 (CAU). Mean QALYs ranged .507 (CAU) to .540 (MCGP-CS). MCGP-CS had a probability of 74% to be both less costly and more effective than CAU, and 49% compared with SGP. Sensitivity analyses showed these findings are robust. If society is willing to pay €0 for one gained QALY, MCGP-CS has a 78% probability of being cost-effective compared with CAU. This increases to 85% and 92% at willingness-to-pay thresholds of €10 000 and €30 000, which are commonly accepted thresholds. CONCLUSIONS: MCGP-CS is highly likely a cost-effective intervention, meaning that there is a positive balance between the costs and gains of MCGP-CS, in comparison with SGP and CAU.

Costs from a healthcare and societal perspective among cancer patients after total laryngectomy: are they related to patient activation?

PURPOSE: The aim of this study is to investigate the associations between patient activation and total costs in cancer patients treated with total laryngectomy (TL). METHODS: All members of the Dutch Patients' Association for Laryngectomees were asked to participate in this cross-sectional study. TL patients who wanted to participate were asked to complete a survey. Costs were measured using the medical consumption and productivity cost questionnaire and patient activation using the Patient Activation Measure (PAM). Sociodemographic and clinical characteristics were self-reported, and health status measured using the EQ-5D. The difference in total costs from a healthcare and societal perspective among four groups with different PAM levels were compared using (multiple) regression analyses (5000 bootstrap replications). RESULTS: In total, 248 TL patients participated. Patients with a higher (better) PAM (levels 2, 3, and 4) had a probability of 70, 80, and 93% that total costs from a healthcare perspective were lower than in patients with the lowest PAM level (difference €-375 to €-936). From a societal perspective, this was 73, 87, and 82% (difference €-468 to €-719). After adjustment for time since TL, education, and sex, the probability that total costs were lower in patients with a higher PAM level compared to patients with the lowest PAM level changed to 62-91% (healthcare) and 63-92% (societal). After additional adjustment for health status, the probability to be less costly changed to 35-71% (healthcare) and 31-48% (societal). CONCLUSIONS: A better patient activation is likely to be associated with lower total costs from a healthcare and societal perspective.

Self-management support and eHealth for patients and informal caregivers confronted with advanced cancer: an online focus group study among nurses.

BACKGROUND: Self-management by patients and informal caregivers confronted with advanced cancer is not self-evident. Therefore they might need self-management support from nurses. This article reports on nurses' perspectives on self-management support for people confronted with advanced cancer, and nurses' experiences with eHealth in this context. METHODS: Six online focus groups were organized, with a total of 45 Dutch nurses with different educational levels and working in different care settings. Nurses were asked how they support patients and informal caregivers facing advanced cancer in managing physical and psychosocial problems in their daily life. Questions were also asked regarding the nurses' experiences with eHealth. Transcripts of the online focus group discussions were analyzed qualitatively following the principles of thematic analysis. The main themes derived from the analyses were ordered according to the elements in the 5 A's Behavior Change Model. RESULTS: Within the scope of self-management support, nurses reported that they discuss the background, personal situation, wishes, and needs of advanced cancer patients ('Assess' in the 5 A's model), and they provide information about cancer and specifically the advanced type ('Advise'). However, nurses hardly give any advice on how patients can manage physical and psychological problems themselves and/or pay any attention to collaborative goal-setting ('Agree'). Neither do they explain how follow-up can be arranged ('Arrange'). In addition, they do not appear to pay much attention to self-management support for informal caregivers. Nurses' attitudes towards eHealth within the scope of self-management support are positive. They see many advantages, such as allowing advanced cancer patients to stay in charge of their own care and lives. However, nurses also explicitly stressed that eHealth can never be a substitute for personal contact between nurses and patients. CONCLUSIONS: Nurses value self-management support and eHealth for advanced cancer patients and their informal caregivers. However, they seem to disregard important elements in the support of self-management, such as providing practical advice, collaborative goal-setting, and arrangement of follow-up. We recommend further promoting and clarifying the essence and importance of self-management support, including self-management support for informal caregivers.

Effectiveness, cost-utility and implementation of a decision aid for patients with localised prostate cancer and their partners: study protocol of a stepped-wedge cluster randomised controlled trial.

INTRODUCTION: Patient decision aids (PDAs) have been developed to help patients make an informed choice for a treatment option. Despite proven benefits, structural implementation falls short of expectations. The present study aims to assess the effectiveness and cost-utility of the PDA among newly diagnosed patients with localised prostate cancer and their partners, alongside implementation of the PDA in routine care. METHODS/ANALYSIS: A stepped-wedge cluster randomised trial will be conducted. The PDA will be sequentially implemented in 18 hospitals in the Netherlands, over a period of 24 months. Every 3 or 6 months, a new cluster of hospitals will switch from usual care to care including a PDA.The primary outcome measure is decisional conflict experienced by the patient. Secondary outcomes comprise the patient's quality of life, treatment preferences, role in the decision making, expectations of treatment, knowledge, need for supportive care and decision regret. Furthermore, societal cost-utility will be valued. Other outcome measures considered are the partner's treatment preferences, experienced participation to decision making, quality of life, communication between patient, partner and health care professional, and the effect of prostate cancer on the relationship, social contacts and their role as caregiver. Patients and partners receiving the PDA will also be asked about their satisfaction with the PDA.Baseline assessment takes place after the treatment choice and before the start of a treatment, with follow-up assessments at 3, 6 and 12 months following the end of treatment or the day after deciding on active surveillance. Outcome measures on implementation include the implementation rate (defined as the proportion of all eligible patients who will receive a PDA) and a questionnaire for health care professionals on determinants of implementing an innovation. ETHICS AND DISSEMINATION: This study will be conducted in accordance with local laws and regulations of the Medical Ethics Committee of VU University Medical Center, Amsterdam, The Netherlands. The results from this stepped-wedge trial will be presented at scientific meetings and published in peer-reviewed journals. TRIAL REGISTRATION: Nederlands Trial Register NTR TC5177, registration date: May 28th 2015.Pre-results.

Efficacy, cost-utility and reach of an eHealth self-management application 'Oncokompas' that helps cancer survivors to obtain optimal supportive care: study protocol for a randomised controlled trial.

BACKGROUND: Cancer survivors have to deal with a wide range of physical symptoms, psychological, social and existential concerns, and lifestyle issues related to cancer and its treatment. Therefore, it is essential that they have access to optimal supportive care services. The eHealth self-management application Oncokompas was developed to support cancer survivors with where they need to turn to for advice and guidance, as well as to increase their knowledge on the availability of optimal support. A randomised controlled trial will be conducted to assess the efficacy, cost-utility and reach of Oncokompas as an eHealth self-management application compared with care as usual among cancer survivors. METHODS/DESIGN: Adult cancer survivors diagnosed with breast, colorectal or head and neck cancer or lymphoma who are at 3 months to 5 years since curative treatment will be included. In total, 544 cancer survivors will be randomly assigned to the intervention group or a wait-list control group. The primary outcome measure is patient activation. Secondary outcome measures include self-efficacy, personal control, perceived patient-physician interaction, need for supportive care, mental adjustment to cancer and health-related quality of life. Furthermore, cost-utility outcomes will be assessed. Reach is defined as the percentage of cancer survivors who get access to Oncokompas within the context of this trial. Questionnaires will be administered at baseline, post-intervention and at 3- and 6-month follow-up. DISCUSSION: In this study, we will evaluate the efficacy and cost-utility of Oncokompas among cancer survivors, as well as the reach of Oncokompas. These are essential first steps in the translation of research into practice and contribute to sustainable adoption, implementation and maintenance of an evidence-based Oncokompas. TRIAL REGISTRATION: Netherlands Trial Register identifier: NTR5774 . Registered on 8 March 2016.

Cost-Utility of Stepped Care Targeting Psychological Distress in Patients With Head and Neck or Lung Cancer.

Purpose A stepped care (SC) program in which an effective yet least resource-intensive treatment is delivered to patients first and followed, when necessary, by more resource-intensive treatments was found to be effective in improving distress levels of patients with head and neck cancer or lung cancer. Information on the value of this program for its cost is now called for. Therefore, this study aimed to assess the cost-utility of the SC program compared with care-as-usual (CAU) in patients with head and neck cancer or lung cancer who have psychological distress. Patients and Methods In total, 156 patients were randomly assigned to SC or CAU. Intervention costs, direct medical costs, direct nonmedical costs, productivity losses, and health-related quality-of-life data during the intervention or control period and 12 months of follow-up were calculated by using Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry, Productivity and Disease Questionnaire, and EuroQol-5 Dimension measures and data from the hospital information system. The SC program's value for the cost was investigated by comparing mean cumulative costs and quality-adjusted life years (QALYs). Results After imputation of missing data, mean cumulative costs were -€3,950 (95% CI, -€8,158 to -€190) lower, and mean number of QALYs was 0.116 (95% CI, 0.005 to 0.227) higher in the intervention group compared with the control group. The intervention group had a probability of 96% that cumulative QALYs were higher and cumulative costs were lower than in the control group. Four additional analyses were conducted to assess the robustness of this finding, and they found that the intervention group had a probability of 84% to 98% that cumulative QALYs were higher and a probability of 91% to 99% that costs were lower than in the control group. Conclusion SC is highly likely to be cost-effective; the number of QALYs was higher and cumulative costs were lower for SC compared with CAU.

A Review on Cost-Effectiveness and Cost-Utility of Psychosocial Care in Cancer Patients.

Several psychosocial care interventions have been found effective in improving psychosocial outcomes in cancer patients. At present, there is increasingly being asked for information on the value for money of this type of intervention. This review therefore evaluates current evidence from studies investigating cost-effectiveness or cost-utility of psychosocial care in cancer patients. A systematic search was conducted in PubMed and Web of Science yielding 539 unique records, of which 11 studies were included in the study. Studies were mainly performed in breast cancer populations or mixed cancer populations. Studied interventions included collaborative care (four studies), group interventions (four studies), individual psychological support (two studies), and individual psycho-education (one study). Seven studies assessed the cost-utility of psychosocial care (based on quality-adjusted-life-years) while three studies investigated its cost-effectiveness (based on profile of mood states [mood], Revised Impact of Events Scale [distress], 12-Item Health Survey [mental health], or Fear of Progression Questionnaire [fear of cancer progression]). One study did both. Costs included were intervention costs (three studies), intervention and direct medical costs (five studies), or intervention, direct medical, and direct nonmedical costs (three studies). In general, results indicated that psychosocial care is likely to be cost-effective at different, potentially acceptable, willingness-to-pay thresholds. Further research should be performed to provide more clear information as to which psychosocial care interventions are most cost-effective and for whom. In addition, more research should be performed encompassing potential important cost drivers from a societal perspective, such as productivity losses or informal care costs, in the analyses.