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| Name | Class |
|---|---|
| Research Unit of General Practice, Odense | OTHER |
| University of Southern Denmark | OTHER |
| Danish Cancer Society | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Instruction in self-referral | Other |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Fear of Cancer Recurrence Inventory (questionnaire) | change in score between 1, 10 and 34 months |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | ||||
| Research Unit of gynecology, Odense University hospital |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| 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 |
| Odense C |
| 5000 |
| Denmark |
| Roskilde Hospital | Roskilde | Denmark |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |