NCT01853865

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
211

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2013

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

4.6 years

First QC Date

April 22, 2013

Last Update Submit

November 1, 2017

Conditions

Endometrial Cancer

Keywords

Endometrial cancerFollow-up examination

Outcome Measures

Primary Outcomes (1)

  • Fear of Cancer Recurrence Inventory (questionnaire)

    change in score between 1, 10 and 34 months

Secondary Outcomes (8)

  • 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

  • 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

  • Posttraumatic Growth Inventory

    change in score between 1, 10 and 34 months

  • EQ-5D-5L

    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

  • +3 more secondary outcomes

Study Arms (2)

Follow-up

NO INTERVENTION

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

Self-referral

EXPERIMENTAL

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

Other: Instruction in self-referral

Interventions

Instruction in self-referralOTHER
Also known as: Patient-initiated follow-up
Self-referral

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with stage I Endometrial Cancer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aalborg University Hospital

Aalborg, Denmark

Location

Research Unit of gynecology, Odense University hospital

Odense C, 5000, Denmark

Location

Roskilde Hospital

Roskilde, Denmark

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Mette M Mathiesen

    Department of Gynecology, Odense University Hospital

    PRINCIPAL INVESTIGATOR

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

April 22, 2013

First Posted

May 15, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2017

Study Completion

April 1, 2019

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

DK(3)