TY - JOUR
T1 - ENdometrial cancer SURvivors' follow-up carE (ENSURE)
T2 - Less is more? Evaluating patient satisfaction and cost-effectiveness of a reduced follow-up schedule: study protocol of a randomized controlled trial
AU - Ezendam, Nicole P. M.
AU - de Rooij, Belle H.
AU - Kruitwagen, Roy F. P. M.
AU - Creutzberg, Carien L.
AU - van Loon, Ingrid
AU - Boll, Dorry
AU - Vos, M. Caroline
AU - van de Poll-Franse, Lonneke V.
PY - 2018/4/16
Y1 - 2018/4/16
N2 - 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.
AB - 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.
KW - Follow-up care
KW - Reduced follow-up
KW - Patient-initiated
KW - Endometrial cancer
KW - Randomized controlled trial
KW - Patient-reported outcomes
KW - Satisfaction with care
KW - Cost-effectiveness
KW - QUALITY-OF-LIFE
KW - GYNECOLOGICAL CANCER
KW - REPORTED OUTCOMES
KW - EUROPEAN-ORGANIZATION
KW - COLORECTAL-CANCER
KW - DEPRESSION SCALE
KW - HOSPITAL ANXIETY
KW - OVARIAN-CANCER
KW - BREAST-CANCER
KW - QUESTIONNAIRE
U2 - 10.1186/s13063-018-2611-x
DO - 10.1186/s13063-018-2611-x
M3 - Article
C2 - 29661218
SN - 1745-6215
VL - 19
JO - Trials
JF - Trials
M1 - 227
ER -