Follow-up of Endometrial Cancer Patients (OPAL)

Odense University Hospital

Status: Unknown

Conditions: Endometrial Cancer

Treatments: Other: Instruction in self-referral

Study type: Interventional

Funder types: Other

Identifiers

NCT01853865

OPAL

Details and patient eligibility

About

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.

Enrollment: 211 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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211 participants in 2 patient groups

Follow-up

No Intervention group

Description:

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

Self-referral

Experimental group

Description:

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

Treatment:

Other: Instruction in self-referral