Paraganglioma, Pheochromocytoma
Conditions
Keywords
follow-up, recurrence, e-consultation, Pheochromocytoma
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.
Interventions
OTHERUse of an internet plateform
Use of an internet platform for remote monitoring of patients.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| Acceptability | 13 months | Evaluate patient acceptability and satisfaction with the use of the solution using a satisfaction questionnaire. |
| 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. |
| Prognostic factors for recurrence. | 37 months | Establishment of an e-cohort study to look for prognostic factors for recurrence. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORLaurence AMAR, MD, PhD
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed