Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring

Sponsor
Centre Oscar Lambret
Study ID
NCT05500391
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

First listed
Aug 15, 2022
Start date
Feb 28, 2024
Status verified
Mar 2026
Primary completion
Oct 31, 2026
Completion
Jul 31, 2032

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Experimental
    Telesurveillance by a nurse
  • Other: Control
    On-site surveillance by a hospital physician

Primary Outcome Measure

2-year compliance to the customized surveillance plan [ Time Frame: 2 years ]

Central Contacts

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