Clinical trial NCT06297473: Physical Attendance Versus Telephone or Video Follow-up in Patients With Non-functioning Pituitary Tumors.
Official title: Physical Attendance Versus Telephone or Video Follow-up for Prevention of Severe Adverse Events in Patients With Non-functioning Pituitary Tumors. A Pragmatic Randomized Controlled Multi-center Non-inferiority Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-Functional Pituitary Adenoma
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 812
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to either intervention or control
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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

Primary outcomes:
measure: Composite outcome of adverse events
timeFrame: Two year period. From allocation including the routine follow-up after two years.
Secondary outcomes:
measure: Thyroid replacement therapy
timeFrame: At two years follow-up
measure: Growth hormone replacement therapy
timeFrame: At two years follow-up
measure: Desmopressin replacement therapy
timeFrame: At two years follow-up
measure: Hormonal replacement therapy
timeFrame: At two years follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Zealand University Hospital
name: Jesper Krogh, DMSc
role: PRINCIPAL_INVESTIGATOR
References: