Follow-up of Endometrial Cancer Patients

Endometrial Cancer Clinical Trial

— OPAL  

Official title:

Follow-up of Endometrial Cancer Patients: A Valuable Medical Intervention or a Dispensable Force of Habit?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01853865
• Other study ID #: OPAL
• Status: Active, not recruiting
• Phase: N/A
• First received: April 22, 2013
• Last updated: November 1, 2017
• Start date: May 2013
• Est. completion date: April 2019

Study information

• Verified date: November 2017
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 211
• Est. completion date: April 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Other:
• Instruction in self-referral

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Research Unit of gynecology, Odense University hospital	Odense C
Denmark	Roskilde Hospital	Roskilde

Sponsors (4)

Lead Sponsor	Collaborator
Odense University Hospital	Danish Cancer Society, Research Unit of General Practice, Odense, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fear of Cancer Recurrence Inventory (questionnaire)		change in score between 1, 10 and 34 months
Secondary	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
Secondary	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
Secondary	Posttraumatic Growth Inventory		change in score between 1, 10 and 34 months
Secondary	EQ-5D-5L		change in score between 1, 10 and 34 months
Secondary	Items on Unmet needs from the "Coherence for cancer patients questionnaire"		change in score between 1, 10 and 34 months
Secondary	Disease-free survival		3 years following treatment
Secondary	Incidence of disease recurrence		3 years following treatment
Secondary	Resource use at hospital, primary care and use of medicinal products	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