search
Back to results

Follow-up of Endometrial Cancer Patients (OPAL)

Primary Purpose

Endometrial Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Instruction in self-referral
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Endometrial Cancer focused on measuring Endometrial cancer, Follow-up examination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Follow-up

Self-referral

Arm Description

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

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

Outcomes

Primary Outcome Measures

Fear of Cancer Recurrence Inventory (questionnaire)

Secondary Outcome Measures

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Endometrial cancer Module (EORTC QLQ-EN24)
Posttraumatic Growth Inventory
EQ-5D-5L
Items on Unmet needs from the "Coherence for cancer patients questionnaire"
Disease-free survival
Incidence of disease recurrence
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.

Full Information

First Posted
April 22, 2013
Last Updated
November 1, 2017
Sponsor
Odense University Hospital
Collaborators
Research Unit of General Practice, Odense, University of Southern Denmark, Danish Cancer Society
search

1. Study Identification

Unique Protocol Identification Number
NCT01853865
Brief Title
Follow-up of Endometrial Cancer Patients
Acronym
OPAL
Official Title
Follow-up of Endometrial Cancer Patients: A Valuable Medical Intervention or a Dispensable Force of Habit?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
Research Unit of General Practice, Odense, University of Southern Denmark, Danish Cancer Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
Endometrial cancer, Follow-up examination

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Follow-up
Arm Type
No Intervention
Arm Description
Patients in this arm attend regular follow-up examinations, as is the current standard, at the department of gynecology following surgery.
Arm Title
Self-referral
Arm Type
Experimental
Arm Description
Instead of regular follow-up examinations, this group is carefully instructed in alarm symptoms that require contact with a physician.
Intervention Type
Other
Intervention Name(s)
Instruction in self-referral
Other Intervention Name(s)
Patient-initiated follow-up
Primary Outcome Measure Information:
Title
Fear of Cancer Recurrence Inventory (questionnaire)
Time Frame
change in score between 1, 10 and 34 months
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Posttraumatic Growth Inventory
Time Frame
change in score between 1, 10 and 34 months
Title
EQ-5D-5L
Time Frame
change in score between 1, 10 and 34 months
Title
Items on Unmet needs from the "Coherence for cancer patients questionnaire"
Time Frame
change in score between 1, 10 and 34 months
Title
Disease-free survival
Time Frame
3 years following treatment
Title
Incidence of disease recurrence
Time Frame
3 years following treatment
Title
Resource use at hospital, primary care and use of medicinal products
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette M Mathiesen
Organizational Affiliation
Department of Gynecology, Odense University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ole Mogensen, Professor
Organizational Affiliation
Department of Gynecology, Odense University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pernille T Jensen, PhD
Organizational Affiliation
Department of Gynecology, Odense University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dorte G Hansen, Lector, PhD
Organizational Affiliation
Research Unit of General Practice, Odense University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
Country
Denmark
Facility Name
Research Unit of gynecology, Odense University hospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Roskilde Hospital
City
Roskilde
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Follow-up of Endometrial Cancer Patients

We'll reach out to this number within 24 hrs