Clinical trial NCT02413606: ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More?
Official title: ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More? Randomized Controlled Trial to Evaluate Patient Satisfaction and Cost-effectiveness of a Reduced Follow-up Schedule
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Keywords: follow up care
satisfaction with care
Lead sponsor: Comprehensive Cancer Centre The Netherlands
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
name: Maastricht University Medical Center
name: Leiden University Medical Center
First posted: 2015-04-10
Enrollment: 319
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Patients with Endometrioïd type endometrial carcinoma with stage 1 (FIGO, 2009) disease, with the following combination of stage, age and grade:

   Stage 1A, any age, grade 1 or 2; Stage 1B, \< 60 years, grade 1 or 2 without LVSI;
2. Written informed consent;
3. Sufficient oral and written command of the Dutch language.

Exclusion Criteria:

1. Any other stage and type of endometrial carcinoma
2. Histological types papillary serous carcinoma or clear cell carcinoma
3. Uterine sarcoma (including carcinosarcoma)
4. Radiotherapy for current endometrial carcinoma
5. Previous malignancy (except for non-melanomatous skin cancer) \< 5 yrs
6. Confirmed Lynch syndrome
7. Previous pelvic radiotherapy

Primary outcomes:
measure: Patient satisfaction with follow-up care
timeFrame: up to 60 months after completion of primary treatment
measure: Costs-effectiveness
timeFrame: assessed at 60 months after completion of primary treatment
Secondary outcomes:
measure: Costs-effectiveness
timeFrame: assessed at 36 months after completion of primary treatment
measure: 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
timeFrame: assessed at 6, 12 and 36 months after completion of primary treatment
measure: 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
timeFrame: assessed at 6, 12, 36, and 60 months after completion of primary treatment
measure: Health-Related Quality of Live
timeFrame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment
measure: Health-Related Quality of Live
timeFrame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
measure: Worry including fear of recurrence
timeFrame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment
measure: Worry including fear of recurrence
timeFrame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
measure: Illness perceptions
timeFrame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment
measure: Illness perceptions
timeFrame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
measure: Anxiety and depression
timeFrame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment
measure: Anxiety and depression
timeFrame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
measure: Satisfaction with information provision
timeFrame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment
measure: Satisfaction with information provision
timeFrame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
measure: Health care providers' satisfaction with follow-up schedule (gynaecologist, (specialised) nurse)
timeFrame: assessed at 36 months after completion of primary treatment
measure: Health care providers' satisfaction with follow-up schedule (gynaecologist, (specialised) nurse)
timeFrame: assessed at 60 months after completion of primary treatment
measure: Time till recurrence
timeFrame: assessed at 36 months after completion of primary treatment
measure: Time till recurrence
timeFrame: assessed at 60 months after completion of primary treatment
measure: Survival
timeFrame: assessed at 36 months after completion of primary treatment
measure: Survival
timeFrame: assessed at 60 months after completion of primary treatment
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Noordwest ziekhuisgroep
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Amstelveen
country: Netherlands
facility: Amstelland Ziekenuis
city: Amsterdam
country: Netherlands
facility: AMC
city: Amsterdam
country: Netherlands
facility: AVL
city: Amsterdam
country: Netherlands
facility: OLVG
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen
city: Bergen op Zoom
country: Netherlands
facility: Bravis
city: Blaricum
country: Netherlands
facility: Tergooi
city: Breda
country: Netherlands
facility: Amphia
city: Delft
country: Netherlands
facility: Reinier de Graaf Hospital
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch
city: Den Haag
country: Netherlands
facility: Haga hospital
city: Den Haag
country: Netherlands
facility: MC Haaglanden
city: Deventer
country: Netherlands
facility: Deventer Hospital
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Enschede
country: Netherlands
facility: Medical Spectrum Twente
city: Gouda
country: Netherlands
facility: Groene Hart
city: Groningen
country: Netherlands
facility: Martini Hospital
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Hardenberg
country: Netherlands
facility: Röpcke-Zweers Ziekenhuis
city: Heerenveen
country: Netherlands
facility: Tjongerschans
city: Heerlerheide
country: Netherlands
facility: Zuyderland Hospital
city: Hoorn
country: Netherlands
facility: Westfries Gasthuis
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
city: Leiden
country: Netherlands
facility: Alrijne Ziekenhuis
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Nieuwegein
country: Netherlands
facility: St. Antonius
city: Purmerend
country: Netherlands
facility: Waterland Ziekenhuis
city: Roosendaal
country: Netherlands
facility: Bravis
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis
city: Schiedam
country: Netherlands
facility: Vlietland
city: Sittard
country: Netherlands
facility: Zuyderland
city: Stadskanaal
country: Netherlands
facility: Refaja
city: Tilburg
country: Netherlands
facility: Elisabeth TweeSteden, TweeSteden
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden
city: Uden
country: Netherlands
facility: Bernhoven
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Venlo
country: Netherlands
facility: VieCuri
city: Winterswijk
country: Netherlands
facility: Streekziekenhuis Koningin Beatrix
city: Woerden
country: Netherlands
facility: Zuwe Hofpoort
city: Zaandam
country: Netherlands
facility: Zaans Medisch Centrum
city: Zoetermeer
country: Netherlands
facility: Langeland
city: Zutphen
country: Netherlands
facility: Gelre Ziekenhuizen
city: Zwolle
country: Netherlands
facility: Isala kliniek
Study officials:
affiliation: Comprehensive Cancer Centre The Netherlands
name: Lonneke van de Poll-Franse, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Centre
name: Roy Kruitwagen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Leiden University Medical Centre
name: Carien Creutzberg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Comprehensive Cancer Centre The Netherlands
name: Nicole Ezendam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ezendam NPM, de Rooij BH, Kruitwagen RFPM, Creutzberg CL, van Loon I, Boll D, Vos MC, van de Poll-Franse LV. 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. Trials. 2018 Apr 16;19(1):227. doi: 10.1186/s13063-018-2611-x.