Development of a Tele-monitoring Program for Patients Undergoing Surgery for Pheochromocytoma and / or Paraganglioma

Pheochromocytoma Clinical Trial

— e-PPGL  

Official title:

Development of a Tele-monitoring Program for Patients Undergoing Surgery for Pheochromocytoma and / or Paraganglioma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04573816
• Other study ID #: D20170803
• Secondary ID: 2020-A00144-35
• Status: Recruiting
• Start date: October 8, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: January 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Laurence AMAR, MD, PhD
• Phone: 33 156 093 771
• Email: laurence.amar[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pheochromocytomas and paragangliomas (PPGL) are rare tumors treated by surgical excision. During follow-up, more than 15% of patients will have recurrences in the form of new tumors, locoregional recurrence or metastases. This subgroup is initially not identifiable. It is therefore usual to perform annual monitoring of all patients throughout their lives by questioning and measuring blood pressure during a medical consultation and by measuring urinary or plasma metanephrines and normetanephrines. The main objective of this prospective monocentric study is to evaluate the reliability of an optimized remote monitoring program in comparison to a usual in-clinic monitoring of patients surgically-cured and tumor-free at the time of inclusion.

Description:

Patients will be included in a follow-up consultation or during a telephone contact prior to a consultation. The period of follow-up by internet and the date of the next consultation will be fixed. This assessment is annual according to current recommendations. In the two months prior to the consultation, patients will fill out a questionnaire and transcribe their blood pressure self-measurement results as well as their biological assessment on a dedicated, approved data-hosting platform (internet application named HERMES). During the consultation, these items will be collected again without the knowledge of the results entered by the patient on the data hosting site.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 139
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient at least 18 years old
• Follow-up after surgery of a pheochromocytoma or a paraganglioma at the European Hospital Georges Pompidou (Paris, France)
• Free from recurrences and / or metastases at inclusion
• Non-opposition of participation in research

Exclusion Criteria:

• Lack of internet access
• Patient not understanding French
• Patient living abroad, unable to come for consultation
• Patient with co-morbidity involving life threatening within one year of inclusion
• Pregnant or breastfeeding woman

Related Conditions & MeSH terms

• Paraganglioma
• Pheochromocytoma

Intervention

Other:
• Use of an internet plateform
Use of an internet platform for remote monitoring of patients.

Locations

Country	Name	City	State
France	Hopital européen Georges Pompidou	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

Amar L, Fassnacht M, Gimenez-Roqueplo AP, Januszewicz A, Prejbisz A, Timmers H, Plouin PF. Long-term postoperative follow-up in patients with apparently benign pheochromocytoma and paraganglioma. Horm Metab Res. 2012 May;44(5):385-9. doi: 10.1055/s-0031-1301339. Epub 2012 Feb 20. Review. — View Citation

Plouin PF, Amar L, Dekkers OM, Fassnacht M, Gimenez-Roqueplo AP, Lenders JW, Lussey-Lepoutre C, Steichen O; Guideline Working Group. European Society of Endocrinology Clinical Practice Guideline for long-term follow-up of patients operated on for a phaeochromocytoma or a paraganglioma. Eur J Endocrinol. 2016 May;174(5):G1-G10. doi: 10.1530/EJE-16-0033. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability of the program	Proportion of patients with a concordance score greater than or equal to 85% between the data collected in consultation and those entered by the patient via the optimized remote monitoring program	13 months
Secondary	Reminders	Evaluate feasibility of the ability of patients to actively participate in their care pathway (self care; self monitoring): number of reminders.	13 months
Secondary	Schedule compliance	Evaluate feasibility of the ability of patients to actively participate in their care pathway (self care; self monitoring): compliance with planned deadlines.	13 months
Secondary	Data filling	Evaluate feasibility of the ability of patients to actively participate in their care pathway (self care; self monitoring): completion of questionnaires (clinical data, blood pressure measurement and biological results).	13 months
Secondary	Acceptability	Evaluate patient acceptability and satisfaction with the use of the solution using a satisfaction questionnaire.	13 months
Secondary	Lost to follow-up	Establishment of an e-cohort study to evaluate the rate of patients lost to follow-up compared to the historical cohort.	37 months
Secondary	Prognostic factors for recurrence.	Establishment of an e-cohort study to look for prognostic factors for recurrence.	37 months