Endometrial Cancer
Conditions
Keywords
Endometrial cancer, Follow-up examination
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.
Interventions
OTHERInstruction in self-referral
Sponsors
Research Unit of General Practice, Odense
University of Southern Denmark
Danish Cancer Society
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fear of Cancer Recurrence Inventory (questionnaire) | change in score between 1, 10 and 34 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| 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 | During the three years following treatment | 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. |
| Items on Unmet needs from the Coherence for cancer patients questionnaire | change in score between 1, 10 and 34 months | — |
Countries
Denmark
Outcome results
None listed