Follow-up of Endometrial Cancer Patients

NCT ID: NCT01853865

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2019-04-30

Brief Summary

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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

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Conditions

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Endometrial Cancer

Keywords

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Endometrial cancer Follow-up examination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Follow-up

Patients in this arm attend regular follow-up examinations, as is the current standard, at the department of gynecology following surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Self-referral

Instead of regular follow-up examinations, this group is carefully instructed in alarm symptoms that require contact with a physician.

Group Type EXPERIMENTAL

Instruction in self-referral

Intervention Type OTHER

Interventions

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Instruction in self-referral

Intervention Type OTHER

Other Intervention Names

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Patient-initiated follow-up

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Research Unit of General Practice, Odense

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role collaborator

Danish Cancer Society

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mette Moustgaard Mathiesen

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mette M Mathiesen

Role: PRINCIPAL_INVESTIGATOR

Department of Gynecology, Odense University Hospital

Ole Mogensen, Professor

Role: STUDY_CHAIR

Department of Gynecology, Odense University Hospital

Pernille T Jensen, PhD

Role: STUDY_CHAIR

Department of Gynecology, Odense University Hospital

Dorte G Hansen, Lector, PhD

Role: STUDY_CHAIR

Research Unit of General Practice, Odense University Hospital

Locations

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Aalborg University Hospital

Aalborg, , Denmark

Site Status

Research Unit of gynecology, Odense University hospital

Odense C, , Denmark

Site Status

Roskilde Hospital

Roskilde, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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OPAL

Identifier Type: -

Identifier Source: org_study_id