Follow-up of Endometrial Cancer Patients (OPAL)

November 1, 2017 updated by: Mette Moustgaard Mathiesen, Odense University Hospital

Follow-up of Endometrial Cancer Patients: A Valuable Medical Intervention or a Dispensable Force of Habit?

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

211

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Diagnosed with stage I Endometrial Cancer

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Patient-initiated follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fear of Cancer Recurrence Inventory (questionnaire)
Time Frame: change in score between 1, 10 and 34 months
change in score between 1, 10 and 34 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change in score between 1, 10 and 34 months
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
change in score between 1, 10 and 34 months
Posttraumatic Growth Inventory
Time Frame: change in score between 1, 10 and 34 months
change in score between 1, 10 and 34 months
EQ-5D-5L
Time Frame: change in score between 1, 10 and 34 months
change in score between 1, 10 and 34 months
Items on Unmet needs from the "Coherence for cancer patients questionnaire"
Time Frame: change in score between 1, 10 and 34 months
change in score between 1, 10 and 34 months
Disease-free survival
Time Frame: 3 years following treatment
3 years following treatment
Incidence of disease recurrence
Time Frame: 3 years following treatment
3 years following treatment
Resource use at hospital, primary care and use of medicinal products
Time Frame: During the three years following treatment

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.

During the three years following treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mette M Mathiesen, Department of Gynecology, Odense University Hospital
  • Study Chair: Ole Mogensen, Professor, Department of Gynecology, Odense University Hospital
  • Study Chair: Pernille T Jensen, PhD, Department of Gynecology, Odense University Hospital
  • Study Chair: Dorte G Hansen, Lector, PhD, Research Unit of General Practice, Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

April 22, 2013

First Submitted That Met QC Criteria

May 10, 2013

First Posted (Estimate)

May 15, 2013

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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