Physical Attendance Versus Telephone or Video Follow-up in Patients With Non-functioning Pituitary Tumors. (PITCARE)

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.

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Non-Functional Pituitary Adenoma
• Intervention / Treatment: Behavioral: Telephone-/video follow-up; Behavioral: In-person follow-up

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.

• Study Type: Interventional
• Enrollment (Estimated): 812
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jesper Krogh, DMSc; Phone Number: +4525535485; Email: jekrog@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telephone-/video follow-up; Yearly routine review of patients status will take place by using telephone- or video consultation.	Behavioral: Telephone-/video follow-up; 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.
Active Comparator: Standard; Yearly routine review of patients status will take place as an in-person interview	Behavioral: In-person follow-up; The yearly routine review on patients takes place at the endocrine outpatient department

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite outcome of adverse events	The primary outcome is a composite outcome comprised of the three individual outcomes considered of equal importance to patients and clinicians: Risk of admission for adrenal crisis, risk of admission for severe hypo- or hypernatremia, risk of pituitary surgery with lack of full recovery of vision after surgery.	Two year period. From allocation including the routine follow-up after two years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thyroid replacement therapy	In patients on thyroid replacement therapy: Comparing levels of free T4.	At two years follow-up
Growth hormone replacement therapy	In patients on growth hormone replacement therapy: Comparing IGF-1 levels	At two years follow-up
Desmopressin replacement therapy	In patients on vasopressin replacement therapy: Comparing levels of sodium	At two years follow-up
Hormonal replacement therapy	In patients on hormonal replacement therapy: Comparing levels of total testosterone in men and estradiol in women	At two years follow-up

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Investigators: Principal Investigator: Jesper Krogh, DMSc, Zealand University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Adenoma; Pituitary Neoplasms; Pituitary Diseases
• Other Study ID Numbers: SJ-1050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: No current plan. If relevant researchers with relevant project plan approaches we are willing to share anonymous IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No