RecruitingPhase 2NCT05500391

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


Sponsor

Centre Oscar Lambret

Enrollment

88 participants

Start Date

Feb 28, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria11

  • Positive diagnosis (anatomopathology) of tumor within 12 months
  • Patient 18 years of age or older
  • Patient with one of the following conditions:
  • Desmoid fibromatosis of the abdominal wall operated on or under active surveillance
  • Stage I testicular seminoma (whether or not treated with carboplatin AUC7)
  • Stage I non-seminomatous germ cell tumor (with or without adjuvant BEP chemotherapy)
  • Operated GIST with low risk of relapse
  • 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
  • Low-grade glioma, operated
  • Low-grade neuroendocrine tumor, treated by surgery alone
  • Patient who has given consent to participate in the study

Exclusion Criteria3

  • Contraindication to imaging tests required for the surveillance plan
  • No telephone
  • Patient under guardianship or curatorship

Interventions

OTHEROncological Follow-up

Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)


Locations(3)

CHU Amiens

Amiens, France

Centre François Baclesse

Caen, France

Centre Oscar Lambret

Lille, France

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NCT05500391


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