Follow-up of Endometrial Cancer Patients

Not Applicable

• Conditions: Endometrial Cancer
• Interventions: Other: Instruction in self-referral

• Registration Number: NCT01853865
• Lead Sponsor: Odense University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-22
• Study Start: 2013-05
• Study First Submitted QC: 2013-05-10
• Study First Posted: 2013-05-15
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-01
• Last Update Posted: 2017-11-06
• Primary Completion: 2017-12
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 211

Inclusion Criteria

• Diagnosed with stage I Endometrial Cancer

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-referral	Instruction in self-referral	Instead of regular follow-up examinations, this group is carefully instructed in alarm symptoms that require contact with a physician.

Primary Outcome Measures

Name	Time	Method
Fear of Cancer Recurrence Inventory (questionnaire)	change in score between 1, 10 and 34 months

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	3 years following treatment
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	change in score between 1, 10 and 34 months
EQ-5D-5L	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)	change in score between 1, 10 and 34 months
Items on Unmet needs from the "Coherence for cancer patients questionnaire"	change in score between 1, 10 and 34 months
Incidence of disease recurrence	3 years following treatment
Posttraumatic Growth Inventory	change in score between 1, 10 and 34 months
Resource use at hospital, primary care and use of medicinal products	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.

Trial Locations

Locations (3)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Roskilde Hospital; 🇩🇰 Roskilde, Denmark

Research Unit of gynecology, Odense University hospital; 🇩🇰 Odense C, Denmark