Development of a Tele-monitoring Program for Patients Undergoing Surgery for Pheochromocytoma and / or Paraganglioma
- Conditions
- PheochromocytomaParaganglioma
- Registration Number
- NCT04573816
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief 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.
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 139
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reliability of the program 13 months 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
- Secondary Outcome Measures
Name Time Method Data filling 13 months 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).
Lost to follow-up 37 months Establishment of an e-cohort study to evaluate the rate of patients lost to follow-up compared to the historical cohort.
Reminders 13 months Evaluate feasibility of the ability of patients to actively participate in their care pathway (self care; self monitoring): number of reminders.
Schedule compliance 13 months Evaluate feasibility of the ability of patients to actively participate in their care pathway (self care; self monitoring): compliance with planned deadlines.
Prognostic factors for recurrence. 37 months Establishment of an e-cohort study to look for prognostic factors for recurrence.
Acceptability 13 months Evaluate patient acceptability and satisfaction with the use of the solution using a satisfaction questionnaire.
Trial Locations
- Locations (1)
Hopital européen Georges Pompidou
🇫🇷Paris, France