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Follow-up of Endometrial Cancer Patients (OPAL)

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ClinicalTrials.gov Identifier: NCT01853865
Recruitment Status : Active, not recruiting
First Posted : May 15, 2013
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
Research Unit of General Practice, Odense
University of Southern Denmark
Danish Cancer Society
Information provided by (Responsible Party):
Mette Moustgaard Mathiesen, Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Other: Instruction in self-referral Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Follow-up of Endometrial Cancer Patients: A Valuable Medical Intervention or a Dispensable Force of Habit?
Study Start Date : May 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
No Intervention: Follow-up
Patients in this arm attend regular follow-up examinations, as is the current standard, at the department of gynecology following surgery.
Experimental: Self-referral
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
Other Name: Patient-initiated follow-up




Primary Outcome Measures :
  1. Fear of Cancer Recurrence Inventory (questionnaire) [ Time Frame: change in score between 1, 10 and 34 months ]

Secondary Outcome Measures :
  1. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [ Time Frame: change in score between 1, 10 and 34 months ]
  2. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Endometrial cancer Module (EORTC QLQ-EN24) [ Time Frame: change in score between 1, 10 and 34 months ]
  3. Posttraumatic Growth Inventory [ Time Frame: change in score between 1, 10 and 34 months ]
  4. EQ-5D-5L [ Time Frame: change in score between 1, 10 and 34 months ]
  5. Items on Unmet needs from the "Coherence for cancer patients questionnaire" [ Time Frame: change in score between 1, 10 and 34 months ]
  6. Disease-free survival [ Time Frame: 3 years following treatment ]
  7. Incidence of disease recurrence [ Time Frame: 3 years following treatment ]
  8. Resource use at hospital, primary care and use of medicinal products [ Time Frame: 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853865


Locations
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Denmark
Aalborg University Hospital
Aalborg, Denmark
Research Unit of gynecology, Odense University hospital
Odense C, Denmark, 5000
Roskilde Hospital
Roskilde, Denmark
Sponsors and Collaborators
Odense University Hospital
Research Unit of General Practice, Odense
University of Southern Denmark
Danish Cancer Society
Investigators
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Principal Investigator: Mette M Mathiesen Department of Gynecology, Odense University Hospital
Study Chair: 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

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Responsible Party: Mette Moustgaard Mathiesen, PhD student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01853865     History of Changes
Other Study ID Numbers: OPAL
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Keywords provided by Mette Moustgaard Mathiesen, Odense University Hospital:
Endometrial cancer
Follow-up examination
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female