Follow-up of Endometrial Cancer Patients (OPAL)
|ClinicalTrials.gov Identifier: NCT01853865|
Recruitment Status : Unknown
Verified November 2017 by Mette Moustgaard Mathiesen, Odense University Hospital.
Recruitment status was: Active, not recruiting
First Posted : May 15, 2013
Last Update Posted : November 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Other: Instruction in self-referral||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||211 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Follow-up of Endometrial Cancer Patients: A Valuable Medical Intervention or a Dispensable Force of Habit?|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||April 2019|
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.
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
Other Name: Patient-initiated follow-up
- Fear of Cancer Recurrence Inventory (questionnaire) [ Time Frame: change in score between 1, 10 and 34 months ]
- 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 ]
- 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 ]
- Posttraumatic Growth Inventory [ Time Frame: change in score between 1, 10 and 34 months ]
- EQ-5D-5L [ Time Frame: 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 ]
- Disease-free survival [ Time Frame: 3 years following treatment ]
- Incidence of disease recurrence [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853865
|Aalborg University Hospital|
|Research Unit of gynecology, Odense University hospital|
|Odense C, Denmark, 5000|
|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|