Follow-up of Endometrial Cancer Patients

Study Overview
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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.

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

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Other: Instruction in self-referral


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Follow-up<br>Patients in this arm attend regular follow-up examinations, as is the current standard, at the department of gynecology following surgery. | |
| Experimental: Self-referral<br>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<br> <br> * Other names: Patient-initiated follow-up;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of Cancer Recurrence Inventory (questionnaire) |  | change in score between 1, 10 and 34 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Disease-free survival |  | 3 years following treatment | 
| Incidence of disease recurrence |  | 3 years following treatment | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial cancer, Follow-up examination