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Trial Title:
Physical Attendance Versus Telephone or Video Follow-up in Patients With Non-functioning Pituitary Tumors.
NCT ID:
NCT06297473
Condition:
Non-Functional Pituitary Adenoma
Conditions: Official terms:
Adenoma
Pituitary Neoplasms
Pituitary Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients will be randomized to either intervention or control
Primary purpose:
Health Services Research
Masking:
Single (Outcomes Assessor)
Masking description:
Adverse events (primary outcome) will be established by a blinded adjudication committee.
A committé of external endocrinologist/ophthalmologist will blinded to participant
ID/allocation assess all the participants admissions to hospital and assess wether it
qualifies as an event
Intervention:
Intervention type:
Behavioral
Intervention name:
Telephone-/video follow-up
Description:
The yearly routine review of patients takes place by using a telephone or video interview
rather than in-person interview in the endocrine outpatient department.
All other assessments, e.g. biochemical, MRI, is conducted as usual.
Arm group label:
Telephone-/video follow-up
Intervention type:
Behavioral
Intervention name:
In-person follow-up
Description:
The yearly routine review on patients takes place at the endocrine outpatient department
Arm group label:
Standard
Summary:
The primary purpose of this study is to compare the safety of routine telephone
assessment versus in-person assessment during a two-year period for patients with
non-functioning pituitary adenomas. Secondly, to compare the quality of pituitary care in
persons having biochemical assessment once versus twice a year. Thirdly, to assess the
rationale of repeated assessment of pituitary function and imaging in patients with small
pituitary tumors (microadenomas).
Detailed description:
This study intends to investigate the treatment quality, treatment safety, and patient
satisfaction of increased use of telephone/video clinics compared to physical attendance
during a three year period. Secondly, the study will assess the impact of reducing
biochemical assessment by 50 % and explore the possibility of reducing patients with
non-functioning pituitary tumors (NFPTs) affiliated to endocrine departments by 10 - 20
%.
Objective
1. The primary objective is to compare a phone/video follow-up versus standard
follow-up in adults with stable non-functioning pituitary tumors for the risk of
admission for acute adrenal crisis, poor visual outcome after pituitary surgery, or
admission with hypo- or hypernatremia caused by diabetes insipidus.
2. Main secondary objective is to compare yearly endocrine check-up versus endocrine
check-up every 6 months in adults with stable non-functioning pituitary tumors for
adequate control of hormonal replacement therapy.
3. To assess whether hormonal replacement therapy in patients followed by phone/video
consultation is non-inferior to patients followed with standard treatment.
4. Another secondary objective is to use the collected data to quantify the risk of
surgery/radiotherapy of pituitary tumor due to tumor growth or new endocrinopathies
in patients with micro-NFPTs.
Design This study is an investigator initiated pragmatic multicenter non-inferiority
trial with blinded outcome assessment.
Trial procedure Eligible patients will be approached at the yearly routine visit for
information of the trial. Patients fulfilling the inclusion criteria and none of
exclusion criteria will offered enrollment in the trial. Patients will be randomized to
either at standard treatment, planned yearly in-person visits for the next two years, or
the intervention which is planned yearly control by telephone or video contact for the
next two years. Following randomization there a no restrictions on patient care. Primary
outcome will be assessed from randomization to the last visit (2 years from
randomization) by a blinded adjudication committee.
A nurse or medical student will continuously monitor patient files for events. The study
is planned to run from April 1st 2024 to January 1st 2028.
Information from patient files Once patients have accepted participation in the trial,
information regarding previous disease history will be extracted. This include
information on co-morbidity, development of pituitary MRI findings, development in
ophthalmological findings, biochemistry, treatment related to pituitary failure, and
treatment related to pituitary adenoma in the form of surgery or radiotherapy.
Intervention Participants allocated to the intervention-group will receive their annual
endocrine review as a telephone or video contact for two years in a row. There will be no
differences in endocrine review, e.g. biochemical assessment or MRI. Patients or treating
physician can choose to make in-person assessment or follow-up if needed.
Comparator group Participants allocated to the comparator group will receive standard
treatment with yearly in-person assessment, e.g. biochemical and MRI.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Non-functioning pituitary tumor
- Diagnosed > 6 months from enrollment, i.e. found on MRI.
Exclusion Criteria:
- Planned pituitary surgery
- Planned radiotherapy
- Poor Danish skills
- Patient is considered by the treating physician unsuitable for follow-up by
telephone or video
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 1, 2024
Completion date:
August 1, 2028
Lead sponsor:
Agency:
Zealand University Hospital
Agency class:
Other
Source:
Zealand University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06297473