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ENdometrial cancer SURvivors' follow-up carE (ENSURE): Less is more? Evaluating patient satisfaction and cost-effectiveness of a reduced follow-up schedule: study protocol of a randomized controlled trial.

ABSTRACT: BACKGROUND:It has often been hypothesized that the frequency of follow-up visits for patients with early-stage endometrial cancer could be decreased. However, studies evaluating effects of a reduced follow-up schedule among this patient group are lacking. The aim of this study is to assess patient satisfaction and cost-effectiveness of a less frequent follow-up schedule compared to the schedule according to the Dutch guideline. METHODS:In this multicenter randomized controlled trial, patients diagnosed in the Netherlands with stage 1A and 1B low-risk endometrial cancer, for whom adjuvant radiotherapy is not indicated (n =?282), are randomized. Patients allocated to the intervention group receive four follow-up visits during three years. Patients allocated to the control group receive 10-13 follow-up visits during five years, according to the Dutch guideline. Patients are asked to fill out a questionnaire at baseline and after 6, 12, 36, and 60 months. Primary outcomes include patient satisfaction with follow-up care and cost-effectiveness. Secondary outcomes include healthcare use, adherence to schedule, health-related quality of life, fear of recurrence, anxiety and depression, information provision, recurrence, and survival. Linear regression analyses will be used to assess differences in patient satisfaction with follow-up care between intervention and control group. DISCUSSION:We anticipate that patients in the intervention arm have a similar satisfaction with follow-up care and overall outcomes, but lower healthcare use and costs than patients in the control arm. No differences are expected in quality-adjusted life-years and satisfaction, but the reduced schedule is expected to be cost-saving when implemented in the Netherlands. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02413606 . Registered on 10 April 2015.

SUBMITTER: Ezendam NPM

PROVIDER: S-EPMC5902894 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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ENdometrial cancer SURvivors' follow-up carE (ENSURE): Less is more? Evaluating patient satisfaction and cost-effectiveness of a reduced follow-up schedule: study protocol of a randomized controlled trial.

Ezendam Nicole P M NPM de Rooij Belle H BH Kruitwagen Roy F P M RFPM Creutzberg Carien L CL van Loon Ingrid I Boll Dorry D Vos M Caroline MC van de Poll-Franse Lonneke V LV

Trials 20180416 1

<h4>Background</h4>It has often been hypothesized that the frequency of follow-up visits for patients with early-stage endometrial cancer could be decreased. However, studies evaluating effects of a reduced follow-up schedule among this patient group are lacking. The aim of this study is to assess patient satisfaction and cost-effectiveness of a less frequent follow-up schedule compared to the schedule according to the Dutch guideline.<h4>Methods</h4>In this multicenter randomized controlled tri ...[more]

PMID: 29661218

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Project description:BackgroundSCORE is the first randomised controlled trial (RCT) to examine shared oncologist and general practitioner (GP) follow-up for survivors of colorectal cancer (CRC). SCORE aimed to show that shared care (SC) was non-inferior to usual care (UC) on the EORTC QLQ-C30 Global Health Status/Quality of Life (GHQ-QoL) scale to 12 months.MethodsThe study recruited patients from five public hospitals in Melbourne, Australia between February 2017 and May 2021. Patients post curative intent treatment for stage I-III CRC underwent 1:1 randomisation to SC and UC. SC replaced two oncologist visits with GP visits and included a survivorship care plan and primary care management guidelines. Assessments were at baseline, 6 and 12 months. Difference between groups on GHQ-QoL to 12 months was estimated from a mixed model for repeated measures (MMRM), with a non-inferiority margin (NIM) of -10 points. Secondary endpoints included quality of life (QoL); patient perceptions of care; costs and clinical care processes (CEA tests, recurrences). Registration ACTRN12617000004369p.Findings150 consenting patients were randomised to SC (N = 74) or UC (N = 76); 11 GPs declined. The mean (SD) GHQ-QoL scores at 12 months were 72 (20.2) for SC versus 73 (17.2) for UC. The MMRM mean estimate of GHQ-QoL across the 6 month and 12 month follow-up was 69 for SC and 73 for UC, mean difference -4.0 (95% CI: -9.0 to 0.9). The lower limit of the 95% CI did not cross the NIM. There was no clear evidence of differences on other QoL, unmet needs or satisfaction scales. At 12 months, the majority preferred SC (40/63; 63%) in the SC group, with equal preference for SC (22/62; 35%) and specialist care (22/62; 35%) in UC group. CEA completion was higher in SC. Recurrences similar between arms. Patients in SC on average incurred USD314 less in health costs versus UC patients.InterpretationSC seems to be an appropriate and cost-effective model of follow-up for CRC survivors.FundingVictorian Cancer Agency and Cancer Australia.

Project description:BACKGROUND:To date, no standard follow-up guidelines exist regarding patients receiving ablation for initial recurrent hepatocellular carcinoma (HCC). We aimed to explore whether intensive follow-up could benefit these patients. METHODS:We reviewed the clinical data of patients who received complete ablation for initial HCC recurrence after curative treatments in our institution from January 2005 to June 2017. Risk factors for second recurrence of HCC were identified by univariate and multivariate analyses. Patients were classified into low- and high-risk groups according to the outcome of the classification and regression model. The patients were further categorized into short- (<?3?months) and long-interval (3-6?months) follow-up subgroups based on their surveillance in the first 2 years after complete ablation for initial recurrence. The Kaplan-Meier method with log-rank test was performed to compare the overall survival (OS) based on follow-up intervals in each risk group. We also validated our results by stratifying patients into subgroups with different numbers of risk factors and comparing the OS between patients with different follow-up intervals. RESULTS:A total of 361 patients were enrolled. The risk factors for secondary recurrence included the Barcelona Clinic Liver Cancer (BCLC) stage at initial recurrence and first recurrence-free survival after curative treatments for primary HCC (p?<?0.001 and p?=?0.002). Two risk groups (low and high) were identified. In both the low- and high-risk groups, the OS of patients was not associated with intervals of follow-up (p?=?0.29 and 0.49). No significant difference was found in the rates of BCLC 0/A stage, tumor location or curative treatments for the second recurrence by different follow-up intervals in each risk group (p?=?0.34 and 0.87; p?=?0.69 and 0.97). The same tendency was found in subgroups with 0/1/2 risk factors for secondary recurrence during validation. CONCLUSION:The long-interval follow-up did not compromise the survival of patients with complete ablation for initial recurrent HCC.

Dataset Information

ENdometrial cancer SURvivors' follow-up carE (ENSURE): Less is more? Evaluating patient satisfaction and cost-effectiveness of a reduced follow-up schedule: study protocol of a randomized controlled trial.

Publications

ENdometrial cancer SURvivors' follow-up carE (ENSURE): Less is more? Evaluating patient satisfaction and cost-effectiveness of a reduced follow-up schedule: study protocol of a randomized controlled trial.

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