Follow-up of Endometrial Cancer Patients (OPAL)
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|ClinicalTrials.gov Identifier: NCT01853865|
Recruitment Status : 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|