Background: It has often been hypothesized that the frequency of follow-up 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. Objective: Assess patient satisfaction and cost-effectiveness of a less frequent follow-up schedule compared to the schedule according to the Dutch guideline. Study design: Dutch multicentre randomized controlled trial with a 5 year follow-up. Patients (n=282) are randomized in an intervention group with 4 follow-up visits during 3 years, and a control group with 10-13 follow-up visits during 5 years, according to the Dutch guideline. Patients are asked to fill out a questionnaire at baseline, 6, 12, 36 and 60 months. Patient inclusion will take two years (if 60% of the patients participate). Outcomes: Primary: Patient satisfaction with follow-up care and cost-effectiveness. Secondary: health care use, adherence to schedule, health-related quality of life, fear of recurrence, anxiety and depression, information provision, recurrence, survival Patients: Stage 1A and 1B low-risk endometrial cancer patients, for whom adjuvant radiotherapy is not indicated Statistics: linear regression analyses to assess differences in patient satisfaction with follow-up care between intervention and control group adjusted for potential pre-defined confounders. Expected results: Patients in the intervention arm have a similar satisfaction with follow-up care and overall outcomes, but lower health care use and costs than patients in the control arm. No effects are expected on QALY differences (losses) and satisfaction, but the reduced schedule is expected to save 144.000 per year in the Netherlands.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
319
In the intervention group, the follow-up schedule will be limited to four follow-up visits at 3, 12, 24 and 36 months, under the specific condition that patients have easy and prompt access to care (specialised nurse of gynaecologist) if symptoms or questions occur. The content of the follow-up visits will be similar for both groups.
Jeroen Bosch
's-Hertogenbosch, Netherlands
Noordwest ziekhuisgroep
Alkmaar, Netherlands
Meander Medisch Centrum
Amersfoort, Netherlands
Amstelland Ziekenuis
Amstelveen, Netherlands
AMC
Amsterdam, Netherlands
AVL
Amsterdam, Netherlands
Patient satisfaction with follow-up care
assessed with the PSQIII questionnaire; analysed with a repeated mixed model as one overall outcome over all time points
Time frame: up to 60 months after completion of primary treatment
Costs-effectiveness
Cost-effectiveness from the health care perspective using the EQ-5D
Time frame: assessed at 60 months after completion of primary treatment
Costs-effectiveness
Cost-effectiveness from the health care perspective using the EQ-5D
Time frame: assessed at 36 months after completion of primary treatment
Health care use -gynaecologist, (specialist) nurse, primary care physician and other health or care services-; adherence to the indicated follow-up protocols; reasons for non-adherence
health care use is assessed from hospital charges, primary care physician and self-report; analysed with a repeated mixed model as one overall outcome over all time points
Time frame: assessed at 6, 12 and 36 months after completion of primary treatment
Health care use -gynaecologist, (specialist) nurse, primary care physician and other health or care services-; adherence to the indicated follow-up protocols; reasons for non-adherence
health care use is assessed from hospital charges, primary care physician and self-report; analysed with a repeated mixed model as one overall outcome over all time points
Time frame: assessed at 6, 12, 36, and 60 months after completion of primary treatment
Health-Related Quality of Live
assessed with questionnaires: EORTC QLQ-C30 and EORTC QLQ-EN24; analysed with a repeated mixed model as one overall outcome over all time points
Time frame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment
Health-Related Quality of Live
assessed with questionnaires: EORTC QLQ-C30 and EORTC QLQ-EN24; analysed with a repeated mixed model as one overall outcome over all time points
Time frame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
Worry including fear of recurrence
assessed with questionnaire: IOCv2; analysed with a repeated mixed model as one overall outcome over all time points
Time frame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment
Worry including fear of recurrence
assessed with questionnaire: IOCv2; analysed with a repeated mixed model as one overall outcome over all time points
Time frame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
Illness perceptions
assessed with questionnaire: BIPQ; analysed with a repeated mixed model as one overall outcome over all time points
Time frame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment
Illness perceptions
assessed with questionnaire: BIPQ; analysed with a repeated mixed model as one overall outcome over all time points
Time frame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
Anxiety and depression
assessed with questionnaire: HADS; analysed with a repeated mixed model as one overall outcome over all time points
Time frame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment
Anxiety and depression
assessed with questionnaire: HADS; analysed with a repeated mixed model as one overall outcome over all time points
Time frame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
Satisfaction with information provision
assessed with questionnaire: EORTC-INFO25; analysed with a repeated mixed model as one overall outcome over all time points
Time frame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment
Satisfaction with information provision
assessed with questionnaire: EORTC-INFO25; analysed with a repeated mixed model as one overall outcome over all time points
Time frame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
Health care providers' satisfaction with follow-up schedule (gynaecologist, (specialised) nurse)
assessed with structured interviews/questionnaires
Time frame: assessed at 36 months after completion of primary treatment
Health care providers' satisfaction with follow-up schedule (gynaecologist, (specialised) nurse)
assessed with structured interviews/questionnaires
Time frame: assessed at 60 months after completion of primary treatment
Time till recurrence
In this study we will descriptively look at time till recurrence
Time frame: assessed at 36 months after completion of primary treatment
Time till recurrence
In this study we will descriptively look at time till recurrence
Time frame: assessed at 60 months after completion of primary treatment
Survival
descriptively look at survival
Time frame: assessed at 36 months after completion of primary treatment
Survival
descriptively look at survival
Time frame: assessed at 60 months after completion of primary treatment
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