Brief Title
Follow-up of Endometrial Cancer Patients
Official Title
Follow-up of Endometrial Cancer Patients: A Valuable Medical Intervention or a Dispensable Force of Habit?
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.
Study Type
Interventional
Primary Outcome
Fear of Cancer Recurrence Inventory (questionnaire)
Secondary Outcome
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Condition
Endometrial Cancer
Intervention
Instruction in self-referral
Study Arms / Comparison Groups
Follow-up
Description: Patients in this arm attend regular follow-up examinations, as is the current standard, at the department of gynecology following surgery.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
211
Start Date
May 2013
Completion Date
April 2019
Primary Completion Date
December 2017
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Mette M Mathiesen, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT01853865
Organization ID
OPAL
Responsible Party
Principal Investigator
Study Sponsor
Odense University Hospital
Collaborators
Research Unit of General Practice, Odense
Study Sponsor
Mette M Mathiesen, Principal Investigator, Department of Gynecology, Odense University Hospital
Verification Date
November 2017