NCT05500391

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The primary objective of this study is to compare 2-year compliance with the personalized post-treatment surveillance plan between the two arms. 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

• Stage I Testicular Seminoma
• Stage I Testicular Nonseminomatous Germ Cell Tumor
• Gastrointestinal Stromal Tumors
• Ovarian Germ Cell Tumor
• Adenocarcinoma, Clear Cell
• Borderline Ovarian Tumor
• Sex Cord-Stromal Tumor
• Mucinous Adenocarcinoma of Ovary
• Carcinoma, Small Cell
• Carcinosarcoma, Ovarian
• Serous Tumor of Ovary
• Glioma
• Neuroendocrine Tumors
• Aggressive Fibromatosis of Abdominal Wall (Disorder)

Interventions

Type	Name	Description
OTHER	Oncological Follow-up	Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)

Timeline

• Start date: 2024-02-28
• Primary completion: 2026-10-01
• Completion: 2032-07-01
• First posted: 2022-08-15
• Last updated: 2026-03-18

Locations

3 sites across 1 country: France