CClinicalTrials.gg
Status unknownNCT01853865OPALUpdated Nov 6, 2017

Follow-up of Endometrial Cancer Patients

An interventional study of Instruction in self-referral in Endometrial Cancer, sponsored by Odense University Hospital. Status unknown at 3 sites in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-06.

Sponsored by Odense University Hospital · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
211
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

The present study is conducted, to elucidate the value of follow-up examinations in endometrial cancer patients. Specifically the objective is to compare hospital-based follow-up examinations with instruction in self-referral in stage I endometrial cancer patients.

The investigators hypothesize that the intervention, instruction in self-referral, will:

  • reduce fear of recurrence
  • improve quality of life
  • improve cost-utility
  • not affect disease-free survival.
02

Conditions studied

  • Endometrial Cancer

Keywords

  • Endometrial cancer
  • Follow-up examination
03

In context

Endometrial Neoplasms

1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.

This study's enrollment of 211 is above the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.

Browse Endometrial Neoplasms studies →

Lead sponsor

Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed with stage I Endometrial Cancer

Exclusion criteria

Exclusion Criteria:

  • Dementia or other mental/cognitive impairment
  • Illiterate in Danish
  • Treated with adjuvant chemo- and/or radiotherapy
  • high risk histology
  • grade 3
  • follow-up for other gynecologic malignancy
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
211 participants (actual)

Study arms

  • No intervention
    Follow-up

    Patients in this arm attend regular follow-up examinations, as is the current standard, at the department of gynecology following surgery.

  • Experimental
    Self-referral

    Instead of regular follow-up examinations, this group is carefully instructed in alarm symptoms that require contact with a physician.

    Other: Instruction in self-referral

Interventions

  • OtherInstruction in self-referral

    Also known as: Patient-initiated follow-up

06

What researchers measure

Primary outcomes

  1. Fear of Cancer Recurrence Inventory (questionnaire)

    Time frame: change in score between 1, 10 and 34 months

Secondary outcomes

  1. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    Time frame: change in score between 1, 10 and 34 months

  2. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Endometrial cancer Module (EORTC QLQ-EN24)

    Time frame: change in score between 1, 10 and 34 months

  3. Posttraumatic Growth Inventory

    Time frame: change in score between 1, 10 and 34 months

  4. EQ-5D-5L

    Time frame: change in score between 1, 10 and 34 months

  5. Items on Unmet needs from the "Coherence for cancer patients questionnaire"

    Time frame: change in score between 1, 10 and 34 months

  6. Disease-free survival

    Time frame: 3 years following treatment

  7. Incidence of disease recurrence

    Time frame: 3 years following treatment

  8. Resource use at hospital, primary care and use of medicinal products

    Resource use at hospital: will be measured through questionnaires completed by relevant personnel. Information on resource use at primary care and use medicinal products: will be collected through the National Insurance Register and the Medicinal Product Register respectively.

    Time frame: During the three years following treatment

07

Study locations

3 sites
  • Aalborg University Hospital
    Aalborg, Denmark
  • Research Unit of gynecology, Odense University hospital
    Odense C, 5000, Denmark
  • Roskilde Hospital
    Roskilde, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01853865
Lead sponsor
Odense University Hospital
Collaborators
Research Unit of General Practice, Odense, University of Southern Denmark, Danish Cancer Society
Responsible party
Mette Moustgaard Mathiesen (PhD student, Odense University Hospital) — Principal investigator
First posted
May 15, 2013
Start date
May 2013
Primary completion
Dec 2017 (estimated)
Completion
Apr 2019 (estimated)
Last update
Nov 6, 2017

Study contacts

Mette M Mathiesen
principal investigator · Department of Gynecology, Odense University Hospital
Ole Mogensen, Professor
study chair · Department of Gynecology, Odense University Hospital
Pernille T Jensen, PhD
study chair · Department of Gynecology, Odense University Hospital
Dorte G Hansen, Lector, PhD
study chair · Research Unit of General Practice, Odense University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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