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Endometrial CancerENSURENCT02413606

ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More?

A study testing Reduced follow-up schedule in people with Endometrial Cancer, run by Comprehensive Cancer Centre The Netherlands at 47 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
Reduced follow-up schedule
Could I receive a placebo?
No, everyone receives an active treatment
How many people
319 participants
Where
47 sitesNetherlands
Study dates
Sep 2015to Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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;
  • Written informed consent;
  • Sufficient oral and written command of the Dutch language.

Who cannot join

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

Trial locations and contacts

47 sites in 1 country.

47 sites in 1 country

Netherlands47 sites

  • Jeroen Bosch

    's-Hertogenbosch

  • Noordwest ziekhuisgroep

    Alkmaar

  • Meander Medisch Centrum

    Amersfoort

  • Amstelland Ziekenuis

    Amstelveen

  • AMC

    Amsterdam

  • AVL

    Amsterdam

  • OLVG

    Amsterdam

  • Gelre Ziekenhuizen

    Apeldoorn

  • Bravis

    Bergen op Zoom

  • Tergooi

    Blaricum

  • Amphia

    Breda

  • Reinier de Graaf Hospital

    Delft

  • Deventer Hospital

    Deventer

  • Albert Schweitzer Ziekenhuis

    Dordrecht

  • Catharina Hospital

    Eindhoven

  • Medical Spectrum Twente

    Enschede

  • Groene Hart

    Gouda

  • Martini Hospital

    Groningen

  • UMC Groningen

    Groningen

  • Röpcke-Zweers Ziekenhuis

    Hardenberg

  • Tjongerschans

    Heerenveen

  • Zuyderland Hospital

    Heerlerheide

  • Westfries Gasthuis

    Hoorn

  • Medical Center Leeuwarden

    Leeuwarden

  • Alrijne Ziekenhuis

    Leiden

  • Leiden University Medical Center

    Leiden

  • Maastricht University Medical Center

    Maastricht

  • St. Antonius

    Nieuwegein

  • Waterland Ziekenhuis

    Purmerend

  • Bravis

    Roosendaal

  • Franciscus Gasthuis

    Rotterdam

  • Vlietland

    Schiedam

  • Zuyderland

    Sittard

  • Refaja

    Stadskanaal

  • Haga hospital

    The Hague

  • MC Haaglanden

    The Hague

  • Elisabeth TweeSteden, TweeSteden

    Tilburg

  • Elisabeth-TweeSteden

    Tilburg

  • Bernhoven

    Uden

  • Maxima Medisch Centrum

    Veldhoven

  • VieCuri

    Venlo

  • Streekziekenhuis Koningin Beatrix

    Winterswijk

  • Zuwe Hofpoort

    Woerden

  • Zaans Medisch Centrum

    Zaandam

  • Langeland

    Zoetermeer

  • Gelre Ziekenhuizen

    Zutphen

  • Isala kliniek

    Zwolle

Other trials in Netherlands

About this study

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

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.

Read more

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.

Being tested
Reduced follow-up schedule
Keywords
follow up care, satisfaction with care
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reduced follow-up scheduleOther

    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.

Study groups in NCT02413606
Study groupRoleWhat they receive
InterventionExperimentalreduced follow-up schedule: 4 follow-up visits, after 3, 12, 24 and 36 months
Receives: Other: Reduced follow-up schedule
controlNo interventionregular follow-up schedule according to the guideline, 10-13 visits during 5 years

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: up to 60 months after completion of primary treatment

  2. Costs-effectiveness

    Cost-effectiveness from the health care perspective using the EQ-5D

    Measured: assessed at 60 months after completion of primary treatment

Secondary outcomes (19)

  1. Costs-effectiveness

    Cost-effectiveness from the health care perspective using the EQ-5D

    Measured: assessed at 36 months after completion of primary treatment

  2. 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

    Measured: assessed at 6, 12 and 36 months after completion of primary treatment

  3. 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

    Measured: assessed at 6, 12, 36, and 60 months after completion of primary treatment

  4. 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

    Measured: assessed at baseline, 6, 12, and 36 months after completion of primary treatment

  5. 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

    Measured: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment

  6. Worry including fear of recurrence

    assessed with questionnaire: IOCv2; analysed with a repeated mixed model as one overall outcome over all time points

    Measured: assessed at baseline, 6, 12, and 36 months after completion of primary treatment

  7. Worry including fear of recurrence

    assessed with questionnaire: IOCv2; analysed with a repeated mixed model as one overall outcome over all time points

    Measured: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment

  8. Illness perceptions

    assessed with questionnaire: BIPQ; analysed with a repeated mixed model as one overall outcome over all time points

    Measured: assessed at baseline, 6, 12, and 36 months after completion of primary treatment

  9. Illness perceptions

    assessed with questionnaire: BIPQ; analysed with a repeated mixed model as one overall outcome over all time points

    Measured: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment

  10. Anxiety and depression

    assessed with questionnaire: HADS; analysed with a repeated mixed model as one overall outcome over all time points

    Measured: assessed at baseline, 6, 12, and 36 months after completion of primary treatment

  11. Anxiety and depression

    assessed with questionnaire: HADS; analysed with a repeated mixed model as one overall outcome over all time points

    Measured: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment

  12. Satisfaction with information provision

    assessed with questionnaire: EORTC-INFO25; analysed with a repeated mixed model as one overall outcome over all time points

    Measured: assessed at baseline, 6, 12, and 36 months after completion of primary treatment

  13. Satisfaction with information provision

    assessed with questionnaire: EORTC-INFO25; analysed with a repeated mixed model as one overall outcome over all time points

    Measured: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment

  14. Health care providers' satisfaction with follow-up schedule (gynaecologist, (specialised) nurse)

    assessed with structured interviews/questionnaires

    Measured: assessed at 36 months after completion of primary treatment

  15. Health care providers' satisfaction with follow-up schedule (gynaecologist, (specialised) nurse)

    assessed with structured interviews/questionnaires

    Measured: assessed at 60 months after completion of primary treatment

  16. Time till recurrence

    In this study we will descriptively look at time till recurrence

    Measured: assessed at 36 months after completion of primary treatment

  17. Time till recurrence

    In this study we will descriptively look at time till recurrence

    Measured: assessed at 60 months after completion of primary treatment

  18. Survival

    descriptively look at survival

    Measured: assessed at 36 months after completion of primary treatment

  19. Survival

    descriptively look at survival

    Measured: assessed at 60 months after completion of primary treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionMar 2022
  4. Study completionMar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
319 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02413606
Sponsor's protocol ID
IKZ 2014-6677
Acronym
ENSURE
Status last verified
Dec 2023
First submitted
24 Mar 2015
Last updated
6 Dec 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No: After ending the study and analysis of the data, data becomes available for use by other researchers via PROFILES registry, according to the their terms

Publications

  • Ezendam NPM, de Rooij BH, Creutzberg CL, Kruitwagen RFPM, van Lonkhuijzen LRPM, Apperloo MJA, Gerestein K, Baalbergen A, Boll D, Vos MC, van de Poll-Franse LV; ENSURE study group. Effect of reduced follow-up care on patient satisfaction with care among patients with endometrial cancer: The ENSURE randomized controlled trial. Gynecol Oncol. 2024 Sep;188:169-183. doi: 10.1016/j.ygyno.2024.06.020. Epub 2024 Jul 5.

    PubMed 38970844

  • 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.

    PubMed 29661218

Questions about this trial

What is this clinical trial studying?

A study testing Reduced follow-up schedule in people with Endometrial Cancer, run by Comprehensive Cancer Centre The Netherlands at 47 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient satisfaction with follow-up care (time frame: up to 60 months after completion of primary treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02413606, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.

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