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.

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

ACCESS DATA

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.

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

Similar Datasets

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.

Project description:There are no universally accepted guidelines for the follow-up of individuals with cutaneous melanoma. Furthermore, to date, there have been no randomised controlled trials of different models of melanoma follow-up care. This randomised controlled trial was conducted to evaluate the effects of GP-led melanoma follow-up on patient satisfaction, follow-up guideline compliance, anxiety and depression, as well as health status.A randomised controlled trial of GP-led follow-up of cutaneous melanoma was conducted over a period of 1 year with assessment by self-completed questionnaires and review of general practice-held medical records at baseline and 12 months later. It took place in 35 general practices in North-east Scotland. Subjects were 142 individuals (51.4% women 48.6% men; mean (s.d.) age 59.2 (15.2) years previously treated for cutaneous melanoma and free of recurrent disease. The intervention consisted of protocol-driven melanoma reviews in primary care, conducted by trained GPs and supported by centralised recall, rapid access pathway to secondary care and a patient information booklet. The main outcome measure was patient satisfaction measured by questionnaire. Secondary outcomes were adherence to guidelines, health status measured by Short Form-36 and the Hospital Anxiety and Depression Scale.There were significant improvements in 5 out of 15 aspects of patient satisfaction during the study year in those receiving GP-led melanoma follow-up (all P<or=0.01). The intervention group was significantly more satisfied with 7 out of 15 aspects of care at follow-up after adjustment for potential confounders. There was significantly greater adherence to guidelines in the intervention group during the study year. There was no significant difference in health status or anxiety and depression between intervention and control groups at either baseline or outcome.GP-led follow-up is feasible, engenders greater satisfaction in those patients who receive it, permits closer adherence to guidelines and does not result in adverse effects on health status or anxiety and depression when compared with traditional hospital-based follow-up for melanoma.

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.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure