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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06297473
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Zealand University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jesper Krogh, DMSc
Principal Investigator Affiliation	Zealand University Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Non-Functional Pituitary Adenoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Telephone-/video follow-up

Yearly routine review of patients status will take place by using telephone- or video consultation.

Active Comparator: Standard

Yearly routine review of patients status will take place as an in-person interview

Interventions

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.

Behavioral: - In-person follow-up

The yearly routine review on patients takes place at the endocrine outpatient department

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Jesper Krogh, DMSc

jekrog@regionsjaelland.dk

+4525535485

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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