- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01853865
Follow-up of Endometrial Cancer Patients (OPAL)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Aalborg, Denmark
- Aalborg University Hospital
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Odense C, Denmark, 5000
- Research Unit of gynecology, Odense University hospital
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Roskilde, Denmark
- Roskilde Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Experimental: Self-referral
Instead of regular follow-up examinations, this group is carefully instructed in alarm symptoms that require contact with a physician.
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Other Names:
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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
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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
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change in score between 1, 10 and 34 months
|
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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
|
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Posttraumatic Growth Inventory
Time Frame: change in score between 1, 10 and 34 months
|
change in score between 1, 10 and 34 months
|
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EQ-5D-5L
Time Frame: change in score between 1, 10 and 34 months
|
change in score between 1, 10 and 34 months
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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
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Disease-free survival
Time Frame: 3 years following treatment
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3 years following treatment
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Incidence of disease recurrence
Time Frame: 3 years following treatment
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3 years following treatment
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Resource use at hospital, primary care and use of medicinal products
Time Frame: During the three years following treatment
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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
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Collaborators and Investigators
Sponsor
Collaborators
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
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Opal
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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