Randomised controlled trial protocol (GRIP study): examining the effect of involvement of a general practitioner and home care oncology nurse after a cancer diagnosis on patient reported outcomes and healthcare utilization.

BACKGROUND: Due to the ageing population and improving diagnostics and treatments, the number of cancer patients and cancer survivors is increasing. Policymakers, patients and professionals advocate a transfer of (part of) cancer care from the hospital environment to the primary care setting, as this could stimulate personalized and integrated care, increase cost-effectiveness and would better meet the patients' needs and expectations. The effects of structured active follow-up from primary care after cancer diagnosis have not been studied yet. Therefore the GRIP study aims to assess the effects of structured follow-up after a cancer diagnosis, by a primary care team including a general practitioner (GP) and a home care oncology nurse (HON), on satisfaction and healthcare utilization of patients treated with curative intent. METHODS: We will conduct a multicentre, two-arm randomised controlled trial in The Netherlands. We plan to include 150 patients who will be treated with curative intent for either breast, lung, colorectal, gynaecologic cancer, or melanoma. Further inclusion criteria are: age 18 years and older, able to answer questionnaires in Dutch, GP agrees to participate and the possibility to include the patient before the start of treatment. All patients receive care as usual. The intervention arm will receive additional structured follow-up consisting of a GP consultation before onset of treatment to empower the patient for shared decision making with the specialist and a minimum of three contacts with the HON during and after treatment. Primary outcomes are: patient satisfaction with care at the level of specialist, GP and nurse and healthcare utilization. Secondary outcomes include: quality of life, employment status, patient empowerment, shared decision making, mental health and satisfaction with given information. Repeated questionnaires, filled in by the participants, will be assessed within the 1-year study period. DISCUSSION: This randomised controlled trial will evaluate the effects of structured follow-up after a cancer diagnosis by a primary care team including a GP and HON, for patients undergoing treatment with curative intent. Results from the present study may provide the evidence needed to optimally rearrange responsibilities in cancer care delivery and consequently improve cancer care and patient related outcomes. TRIAL REGISTRATION: Trial number: NTR5909 .

Primary care management of women with breast cancer-related concerns-a dynamic cohort study using a network database.

The aim of this study was to determine the incidence, management and diagnostic outcomes of breast cancer-related concerns presented in primary care. A dynamic cohort study was performed in the anonymised routine electronic medical records (EMRs) extracted from 49 General Practices in the Netherlands (163,471 person-years, women aged 18-75). Main Outcome Measures were: (1) incidence rates for breast cancer-related concerns in Primary Care, (2) proportions of these women with and without symptoms of the breast referred for further investigation, (3) proportions of referrals (not) according to the guideline and (4) proportions of women with breast cancer-related concerns diagnosed with breast cancer during follow-up. Breast cancer-related concerns are presented frequently in Primary Care (incidence rate 25.9 per 1,000 women annually). About half these women are referred for further investigation. There is room to improve General Practitioner management, mainly for women with an increased lifetime risk of developing breast cancer. Information concerning family history of cancer is often missing in the EMR. Since cancer is rarely diagnosed during follow-up, particularly when symptoms are absent, reduction of unnecessary concerns is plausible if identification of those without an increased risk is improved.

Cost-effectiveness of targeted screening for hepatitis C in The Netherlands.

On account of the serious complications of hepatitis C virus (HCV) infection and the improved treatment possibilities, the need to improve HCV awareness and case-finding is increasingly recognized. To optimize a future national campaign with this objective, three pilot campaigns were executed in three regions in The Netherlands. One campaign was aimed at the general population, a second (similar) campaign was extended with a support programme for primary care and a third campaign was specifically aimed at hard-drug users. Data from the pilot campaigns were used to build a mathematical model to estimate the incremental cost-effectiveness ratio of the different campaigns. The campaign aimed at the general public without support for primary care did not improve case-finding and was therefore not cost-effective. The similar campaign accompanied by additional support for primary care and the campaign aimed at hard-drug users emerged as cost-effective interventions for identification of HCV carriers.

Effects of structured involvement of the primary care team versus standard care after a cancer diagnosis on patient satisfaction and healthcare use: the GRIP randomised controlled trial.

BACKGROUND: The growing number of cancer survivors and treatment possibilities call for more personalised and integrated cancer care. Primary care seems well positioned to support this. We aimed to assess the effects of structured follow-up of a primary care team after a cancer diagnosis. METHODS: We performed a multicentre randomised controlled trial enrolling patients curatively treated for breast, lung, colorectal, gynaecologic cancer or melanoma. In addition to usual cancer care in the control group, patients randomized to intervention were offered a "Time Out consultation" (TOC) with the general practitioner (GP) after diagnosis, and subsequent follow-up during and after treatment by a home care oncology nurse (HON). Primary outcomes were patient satisfaction with care (questionnaire: EORTC-INPATSAT-32) and healthcare utilisation. Intention-to-treat linear mixed regression analyses were used for satisfaction with care and other continuous outcome variables. The difference in healthcare utilisation for categorical data was calculated with a Pearson Chi-Square or a Fisher exact test and count data (none versus any) with a log-binomial regression. RESULTS: We included 154 patients (control n = 77, intervention n = 77) who were mostly female (75%), mainly diagnosed with breast cancer (51%), and had a mean age of 61 (SD ± 11.9) years. 81% of the intervention patients had a TOC and 68% had HON contact. Satisfaction with care was high (8 out of 10) in both study groups. At 3 months after treatment, GP satisfaction was significantly lower in the intervention group on 3 of 6 subscales, i.e., quality (- 14.2 (95%CI -27.0;-1.3)), availability (- 15,9 (- 29.1;-2.6)) and information provision (- 15.2 (- 29.1;-1.4)). Patients in the intervention group visited the GP practice and the emergency department more often ((RR 1.3 (1.0;1.7) and 1.70 (1.0;2.8)), respectively). CONCLUSIONS: In conclusion, the GRIP intervention, which was designed to involve the primary care team during and after cancer treatment, increased the number of primary healthcare contacts. However, it did not improve patient satisfaction with care and it increased emergency department visits. As the high uptake of the intervention suggests a need of patients, future research should focus on optimizing the design and implementation of the intervention. TRIAL REGISTRATION: GRIP is retrospectively (21/06/2016) registered in the 'Netherlands Trial Register' (NTR5909).

Time to diagnosis of symptomatic gastric and oesophageal cancer in the Netherlands: Where is the room for improvement?

BACKGROUND: An efficient diagnostic pathway and early stage diagnosis for cancer patients is widely pursued. This study aims to chart the duration of the diagnostic pathway for patients with symptomatic oesophageal and gastric cancer, to identify factors associated with long duration and to assess the association of duration with tumour stage at diagnosis. METHODS: This was a retrospective cohort study, using electronic health records of six routine primary care databases covering about 640,000 patients, partly linked to the Netherlands Cancer Registry. Symptomatic patients with oesophageal and gastric cancer (2010-2015) that presented in primary care were included. Duration of four diagnostic intervals was determined: patient interval; first symptoms to primary care consultation, primary care interval; consultation to referral, secondary care interval; referral to diagnosis, and the diagnostic interval; consultation to diagnosis. Characteristics associated with 'long duration' (≥P75 duration) were assessed using log-binomial regression. Median durations were stratified for tumour stages. RESULTS: Among 312 symptomatic patients with upper gastrointestinal cancer, median durations were: patient interval: 29 days (interquartile interval 15-73), primary care interval: 12 days (interquartile interval 1-43), secondary care interval: 13 days (interquartile interval 6-29) and diagnostic interval: 31 days (11-74). Patient interval duration was comparable for patients with and without alarm symptoms. Absence of cancer-specific alarm symptoms was associated with 'long duration' of primary care interval and secondary care interval: relative risk 5.0 (95% confidence interval 2.7-9.1) and 2.1 (95% confidence interval 1.3-3.7), respectively. Median diagnostic interval duration for local stage disease was 51 days (interquartile interval 13-135) versus 27 days (interquartile interval 11-71) for advanced stage (p = 0.07). CONCLUSION: In the diagnostic pathway of upper gastrointestinal cancers, the longest interval is the patient interval. Reducing time to diagnosis may be achieved by improving patients' awareness of alarm symptoms and by diagnostic strategies which better identify cancer patients despite low suspicion.

Real-life costs of hepatitis C treatment.

BACKGROUND: Hepatitis C virus infection is a serious health threat in today's society. Improved identification strategies have increased the number of patients undergoing the expensive treatment with ribavirin and peg-interferon, inducing a substantial economic burden. METHODS: In a retrospective cohort study in three treatment centres in the Netherlands, files of patients treated between 2001 and 2010 were systematically searched for all cost-inducing treatment details. Costs of treatment resulting in sustained viral response (SVR), relapse, non-response and the costs per cured patient were specified for genotype and treatment setting. Determinants of costs were determined by multivariate linear regression. RESULTS: The mean 'real-life' treatment costs excluding side effects for genotype 1/4 and genotype 2/3 were approximately € 12,900 and € 9900 for all patients, € 15,500 and € 10,100 for treatment resulting in SVR and € 16,800 and € 12,100 for relapse, respectively. Costs per cured patient were € 28,500 and € 15,400 respectively. The costs of non-response were approximately € 8000 for all genotypes. Costs of side effects can be high and are mainly caused by incidental treatment for neutropenia. Medication is the main component of treatment costs. Treatment costs were higher in the academic setting due to longer duration and higher costs of side effects. Regression analysis confirms duration as the main determinant of treatment costs excluding side effects. CONCLUSION: The 'real-life' costs of treatment are mainly determined by treatment duration, medication costs and costs of side effects. The costs of unsuccessful treatment are considerable as are the costs of side effects. Therefore, future research should aim at increasing SVR rates, reducing treatment duration and preventing side effects.