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

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

Recruiting
18 years and older
All
Phase 2

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Overview

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).

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

Eligibility

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

Study details
    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)

NCT05500391

Centre Oscar Lambret

16 February 2024

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