Clinical trial NCT01853865: Follow-up of Endometrial Cancer Patients
Official title: Follow-up of Endometrial Cancer Patients: A Valuable Medical Intervention or a Dispensable Force of Habit?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometrial Cancer
Keywords: Endometrial cancer
Follow-up examination
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Research Unit of General Practice, Odense
name: University of Southern Denmark
name: Danish Cancer Society
First posted: 2013-05-15
Enrollment: 211
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Fear of Cancer Recurrence Inventory (questionnaire)
timeFrame: change in score between 1, 10 and 34 months
Secondary outcomes:
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
timeFrame: change in score between 1, 10 and 34 months
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Endometrial cancer Module (EORTC QLQ-EN24)
timeFrame: change in score between 1, 10 and 34 months
measure: Posttraumatic Growth Inventory
timeFrame: change in score between 1, 10 and 34 months
measure: EQ-5D-5L
timeFrame: change in score between 1, 10 and 34 months
measure: Items on Unmet needs from the "Coherence for cancer patients questionnaire"
timeFrame: change in score between 1, 10 and 34 months
measure: Disease-free survival
timeFrame: 3 years following treatment
measure: Incidence of disease recurrence
timeFrame: 3 years following treatment
measure: Resource use at hospital, primary care and use of medicinal products
timeFrame: During the three years following treatment
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Odense C
country: Denmark
facility: Research Unit of gynecology, Odense University hospital
city: Roskilde
country: Denmark
facility: Roskilde Hospital
Study officials:
affiliation: Department of Gynecology, Odense University Hospital
name: Mette M Mathiesen
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Gynecology, Odense University Hospital
name: Ole Mogensen, Professor
role: STUDY_CHAIR
affiliation: Department of Gynecology, Odense University Hospital
name: Pernille T Jensen, PhD
role: STUDY_CHAIR
affiliation: Research Unit of General Practice, Odense University Hospital
name: Dorte G Hansen, Lector, PhD
role: STUDY_CHAIR
References: