Clinical trial · Interventional
Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring
Randomized Phase II Trial Evaluating Compliance With Monitoring Conducted Either by a Hospital-based Physician in Person or by a Nurse in Remote Monitoring
NCT05500391CI-TRIAL-00105796SUR-CANrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, interventional, randomized study among adult patients recently diagnosed with a rare tumor (\<12 months). The study will aim to compare compliance with the personalized post-treatment surveillance plan, established for each patient according to national guidelines, when the surveillance is conducted in person by a hospital-based physician (control arm) or remotely by a trained nurse (experimental arm).
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma, Clear Cell | Clear Cell Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Aggressive Fibromatosis of Abdominal Wall (Disorder) | — | UNRESOLVED | — |
| Borderline Ovarian Tumor | — | UNRESOLVED | — |
| Carcinoma, Small Cell | Small Cell Neuroendocrine Carcinoma | ALIAS | 0.90 |
| Carcinosarcoma, Ovarian | Ovarian Carcinosarcoma | ONTOLOGY_EXACT | 0.98 |
| Gastrointestinal Stromal Tumors | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Mucinous Adenocarcinoma of Ovary | Ovarian Mucinous Adenocarcinoma | ALIAS | 0.90 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oncological Follow-up | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Telesurveillance by a nurse
- interventionNames
- Other: Oncological Follow-up
- type
- OTHER
- label
- Control
- description
- On-site surveillance by a hospital physician
- interventionNames
- Other: Oncological Follow-up
Primary outcomes (1)
- measure
- 2-year compliance to the customized surveillance plan
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Positive diagnosis (anatomopathology) of tumor within 12 months * 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: * Contraindication to imaging tests required for the surveillance plan * No telephone * Patient under guardianship or curatorship
References
Publications (5)
- BACKGROUNDKimman 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. PMID 20429948
- BACKGROUNDMoloney 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. PMID 31280494
- BACKGROUNDMartin 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. PMID 30093916
- BACKGROUNDKeshava 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. PMID 34922758
- BACKGROUNDFerrua 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. PMID 32429987