Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297473
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-28
Brief Title:
Physical Attendance Versus Telephone or Video Follow-up in Patients With Non-functioning Pituitary Tumors
Sponsor:
Zealand University Hospital
Organization:
Zealand University Hospital
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PITCARE
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 telephonevideo 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 phonevideo 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 phonevideo 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 surgeryradiotherapy 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 eg 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 eg biochemical and MRI
Objective
1 The primary objective is to compare a phonevideo 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 phonevideo 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 surgeryradiotherapy 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 eg 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 eg biochemical and MRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None