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| Name | Class |
|---|---|
| Dutch Cancer Society | OTHER |
| Maastricht University Medical Center | OTHER |
| Leiden University Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | reduced follow-up schedule: 4 follow-up visits, after 3, 12, 24 and 36 months |
|
| control | No Intervention | regular follow-up schedule according to the guideline, 10-13 visits during 5 years |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced follow-up schedule | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 60 months after completion of primary treatment |
| Costs-effectiveness | Cost-effectiveness from the health care perspective using the EQ-5D | assessed at 60 months after completion of primary treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Costs-effectiveness | Cost-effectiveness from the health care perspective using the EQ-5D | 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 |
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Inclusion Criteria:
Patients with EndometrioĂŻd 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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lonneke van de Poll-Franse, PhD | Comprehensive Cancer Centre The Netherlands | Principal Investigator |
| Roy Kruitwagen, PhD | Maastricht University Medical Centre | Principal Investigator |
| Carien Creutzberg, PhD | Leiden University Medical Centre | Principal Investigator |
| Nicole Ezendam, PhD | Comprehensive Cancer Centre The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeroen Bosch | 's-Hertogenbosch | Netherlands | ||||
| Noordwest ziekhuisgroep |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38970844 | Derived | 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. | |
| 29661218 |
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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
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|
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 |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | assessed at 60 months after completion of primary treatment |
| Time till recurrence | In this study we will descriptively look at time till recurrence | assessed at 36 months after completion of primary treatment |
| Time till recurrence | In this study we will descriptively look at time till recurrence | assessed at 60 months after completion of primary treatment |
| Survival | descriptively look at survival | assessed at 36 months after completion of primary treatment |
| Survival | descriptively look at survival | assessed at 60 months after completion of primary treatment |
| Alkmaar |
| Netherlands |
| Meander Medisch Centrum | Amersfoort | Netherlands |
| Amstelland Ziekenuis | Amstelveen | Netherlands |
| AMC | Amsterdam | Netherlands |
| AVL | Amsterdam | Netherlands |
| OLVG | Amsterdam | Netherlands |
| Gelre Ziekenhuizen | Apeldoorn | Netherlands |
| Bravis | Bergen op Zoom | Netherlands |
| Tergooi | Blaricum | Netherlands |
| Amphia | Breda | Netherlands |
| Reinier de Graaf Hospital | Delft | Netherlands |
| Deventer Hospital | Deventer | Netherlands |
| Albert Schweitzer Ziekenhuis | Dordrecht | Netherlands |
| Catharina Hospital | Eindhoven | Netherlands |
| Medical Spectrum Twente | Enschede | Netherlands |
| Groene Hart | Gouda | Netherlands |
| Martini Hospital | Groningen | Netherlands |
| UMC Groningen | Groningen | Netherlands |
| Röpcke-Zweers Ziekenhuis | Hardenberg | Netherlands |
| Tjongerschans | Heerenveen | Netherlands |
| Zuyderland Hospital | Heerlerheide | Netherlands |
| Westfries Gasthuis | Hoorn | Netherlands |
| Medical Center Leeuwarden | Leeuwarden | Netherlands |
| Alrijne Ziekenhuis | Leiden | Netherlands |
| Leiden University Medical Center | Leiden | Netherlands |
| Maastricht University Medical Center | Maastricht | Netherlands |
| St. Antonius | Nieuwegein | Netherlands |
| Waterland Ziekenhuis | Purmerend | Netherlands |
| Bravis | Roosendaal | Netherlands |
| Franciscus Gasthuis | Rotterdam | Netherlands |
| Vlietland | Schiedam | Netherlands |
| Zuyderland | Sittard | Netherlands |
| Refaja | Stadskanaal | Netherlands |
| Haga hospital | The Hague | Netherlands |
| MC Haaglanden | The Hague | Netherlands |
| Elisabeth TweeSteden, TweeSteden | Tilburg | Netherlands |
| Elisabeth-TweeSteden | Tilburg | Netherlands |
| Bernhoven | Uden | Netherlands |
| Maxima Medisch Centrum | Veldhoven | Netherlands |
| VieCuri | Venlo | Netherlands |
| Streekziekenhuis Koningin Beatrix | Winterswijk | Netherlands |
| Zuwe Hofpoort | Woerden | Netherlands |
| Zaans Medisch Centrum | Zaandam | Netherlands |
| Langeland | Zoetermeer | Netherlands |
| Gelre Ziekenhuizen | Zutphen | Netherlands |
| Isala kliniek | Zwolle | Netherlands |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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