Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring (SUR-CAN)

Centre Oscar Lambret

Status and phase: Enrolling; Phase 2

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

Treatments: Other: Oncological Follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT05500391

SUR-CAN-2201

Details and patient eligibility

About

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).

Full 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

Enrollment: 88 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Experimental

Experimental group

Description:

Telesurveillance by a nurse

Treatment:

Other: Oncological Follow-up

Control

Other group

Description:

On-site surveillance by a hospital physician

Treatment:

Other: Oncological Follow-up