Endometrial CancerOPALNCT01853865
Follow-up of Endometrial Cancer Patients
A study testing Instruction in self-referral in people with Endometrial Cancer, run by Odense University Hospital at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Instruction in self-referral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 3 sitesDenmark
- Study dates
- May 2013to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with stage I Endometrial Cancer
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Denmark3 sites
Aalborg University Hospital
Aalborg
Research Unit of gynecology, Odense University hospital
Odense C, 5000
Roskilde Hospital
Roskilde
About this study
Official title: Follow-up of Endometrial Cancer Patients: A Valuable Medical Intervention or a Dispensable Force of Habit?
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.
- Conditions
- Endometrial Cancer
- Being tested
- Instruction in self-referral
- Keywords
- Endometrial cancer, Follow-up examination
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instruction in self-referralOther
Also called Patient-initiated follow-up
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Instruction in self-referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of Cancer Recurrence Inventory (questionnaire)
Measured: change in score between 1, 10 and 34 months
Secondary outcomes (8)
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Measured: 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)
Measured: change in score between 1, 10 and 34 months
Posttraumatic Growth Inventory
Measured: change in score between 1, 10 and 34 months
EQ-5D-5L
Measured: change in score between 1, 10 and 34 months
Items on Unmet needs from the "Coherence for cancer patients questionnaire"
Measured: change in score between 1, 10 and 34 months
Disease-free survival
Measured: 3 years following treatment
Incidence of disease recurrence
Measured: 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.
Measured: During the three years following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2017 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Research Unit of General Practice, Odense, University of Southern Denmark, Danish Cancer Society
- Responsible party
- Principal investigator, Mette Moustgaard Mathiesen, Odense University Hospital
- Investigators
- Mette M Mathiesen, Principal investigator, Department of Gynecology, Odense University HospitalOle Mogensen, Professor, Study chair, Department of Gynecology, Odense University HospitalPernille T Jensen, PhD, Study chair, Department of Gynecology, Odense University HospitalDorte G Hansen, Lector, PhD, Study chair, Research Unit of General Practice, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853865
- Sponsor's protocol ID
- OPAL
- Acronym
- OPAL
- Status last verified
- Nov 2017
- First submitted
- 22 Apr 2013
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Endometrial Cancer Patients: A Valuable Medical Intervention or a Dispensable Force of Habit?
- ClinicalTrials.gov ID
- NCT01853865
- Acronym / sponsor ID
- OPAL / OPAL
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial cancer, Follow-up examination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Research Unit of General Practice, Odense, University of Southern Denmark, Danish Cancer Society
- Study start
- May 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 15 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Instruction in self-referralInstead of regular follow-up examinations, this group is carefully instructed in alarm symptoms that require contact with a physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with stage I Endometrial Cancer
Key exclusion criteria (6 listed)
- Dementia or other mental/cognitive impairment
- Illiterate in Danish
- Treated with adjuvant chemo- and/or radiotherapy
- high risk histology
- grade 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instruction in self-referralAlso: Patient-initiated follow-up | Other | Self-referral |
Primary outcome
Fear of Cancer Recurrence Inventory (questionnaire)
Time frame: change in score between 1, 10 and 34 months
8 secondary outcomes
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
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
Posttraumatic Growth Inventory
Time frame: change in score between 1, 10 and 34 months
EQ-5D-5L
Time frame: change in score between 1, 10 and 34 months
Items on Unmet needs from the "Coherence for cancer patients questionnaire"
Time frame: change in score between 1, 10 and 34 months
Disease-free survival
Time frame: 3 years following treatment
Incidence of disease recurrence
Time frame: 3 years following treatment
Resource use at hospital, primary care and use of medicinal products
Time frame: During the three years following treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette M Mathiesen principal investigator
Department of Gynecology, Odense University Hospital
Ole Mogensen, Professor study chair
Department of Gynecology, Odense University Hospital
Pernille T Jensen, PhD study chair
Department of Gynecology, Odense University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instruction in self-referral in people with Endometrial Cancer, run by Odense University Hospital at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of Cancer Recurrence Inventory (questionnaire) (time frame: change in score between 1, 10 and 34 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.