Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring
NCT ID: NCT05500391
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
88 participants
INTERVENTIONAL
2024-02-28
2029-10-31
Brief Summary
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Detailed Description
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The secondary objectives are to compare between the two arms :
* Long-term compliance (5-year follow-up)
* Use of care
* Oncological events and their management
* Supportive care needs
The exploratory objectives are to :
* Evaluate the costs in terms of medical transportation
* Evaluate and compare patients' satisfaction and psychological well-being (in terms of anxiety/depression)
* Evaluate the homogeneity of the impact of the intervention according to covariates (gender, tumor pathology, occupational status, and center)
* Evaluate the reasons for recruitment failures
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Experimental
Telesurveillance by a nurse
Oncological Follow-up
Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)
Control
On-site surveillance by a hospital physician
Oncological Follow-up
Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)
Interventions
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Oncological Follow-up
Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)
Eligibility Criteria
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Inclusion Criteria
* Patient 18 years of age or older
* Patient with one of the following conditions:
1. Desmoid fibromatosis of the abdominal wall operated on or under active surveillance
2. Stage I testicular seminoma (whether or not treated with carboplatin AUC7)
3. Stage I non-seminomatous germ cell tumor (with or without adjuvant BEP chemotherapy)
4. Operated GIST with low risk of relapse
5. Rare gynecological tumors (sex cord and stromal tumors; germ cell tumors of the ovary, clear cell adenocarcinoma, mucinous adenocarcinoma of the ovary, borderline tumors, small cell carcinoma, ovarian and uterine carcinosarcoma, low grade serous tumors), operated
6. Low-grade glioma, operated
7. Low-grade neuroendocrine tumor, treated by surgery alone
* Patient who has given consent to participate in the study
Exclusion Criteria
* No telephone
* Patient under guardianship or curatorship
18 Years
ALL
No
Sponsors
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Canceropôle Nord Ouest
OTHER
Groupement Interrégional de Recherche Clinique et d'Innovation
OTHER
Centre Oscar Lambret
OTHER
Responsible Party
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Principal Investigators
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PENEL Nicolas, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Oscar Lambret
Locations
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CHU Amiens
Amiens, , France
Centre François Baclesse
Caen, , France
Centre Oscar Lambret
Lille, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Kimman ML, Bloebaum MM, Dirksen CD, Houben RM, Lambin P, Boersma LJ. Patient satisfaction with nurse-led telephone follow-up after curative treatment for breast cancer. BMC Cancer. 2010 Apr 30;10:174. doi: 10.1186/1471-2407-10-174.
Moloney J, Partridge C, Delanty S, Lloyd D, Nguyen MH. High efficacy and patient satisfaction with a nurse-led colorectal cancer surveillance programme with 10-year follow-up. ANZ J Surg. 2019 Oct;89(10):1286-1290. doi: 10.1111/ans.15333. Epub 2019 Jul 7.
Martin E, Persaud S, Corr J, Casey R, Pillai R. Nurse-led active surveillance for prostate cancer is safe, effective and associated with high rates of patient satisfaction-results of an audit in the East of England. Ecancermedicalscience. 2018 Jul 25;12:854. doi: 10.3332/ecancer.2018.854. eCollection 2018.
Keshava HB, Tan KS, Dycoco J, Huang J, Berkowitz A, Sumner D, Devigne A, Adusumilli P, Bains M, Bott M, Isbell J, Downey R, Molena D, Park B, Rocco G, Sihag S, Jones DR, Rusch VW. Long-term assessment of efficacy with a novel Thoracic Survivorship Program for patients with lung cancer. J Thorac Cardiovasc Surg. 2022 May;163(5):1645-1653.e4. doi: 10.1016/j.jtcvs.2021.11.026. Epub 2021 Nov 20.
Ferrua M, Minvielle E, Fourcade A, Lalloue B, Sicotte C, Di Palma M, Mir O. How to Design a Remote Patient Monitoring System? A French Case Study. BMC Health Serv Res. 2020 May 19;20(1):434. doi: 10.1186/s12913-020-05293-4.
Other Identifiers
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SUR-CAN-2201
Identifier Type: -
Identifier Source: org_study_id
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