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

Phase 2

Recruiting

• Conditions: Adenocarcinoma, Clear Cell; Sex Cord-Stromal Tumor; Carcinoma, Small Cell; Ovarian Germ Cell Tumor; Mucinous Adenocarcinoma of Ovary; Carcinosarcoma, Ovarian; Serous Tumor of Ovary; Stage I Testicular Nonseminomatous Germ Cell Tumor; Gastrointestinal Stromal Tumors; Borderline Ovarian Tumor
• Interventions: Other: Oncological Follow-up

• Registration Number: NCT05500391
• Lead Sponsor: Centre Oscar Lambret

Brief 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

Study Timeline

• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-12
• Study First Posted: 2022-08-15
• Study Start: 2024-02-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20
• Primary Completion: 2026-10
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Oncological Follow-up	Telesurveillance by a nurse
Control	Oncological Follow-up	On-site surveillance by a hospital physician

Primary Outcome Measures

Name	Time	Method
2-year compliance to the customized surveillance plan	2 years	Compliance is defined by completion of all scheduled examinations (telephone contact, biological, clinical examination and imaging examination) with a margin of + or - 30 days from the scheduled date

Secondary Outcome Measures

Name	Time	Method
Occurrence and management of oncological events	5 years	Occurence and type of oncological event : relapse/progression.; The management of oncological events will be evaluated according to three criteria : * completion of an oncological surgery; * implementation of a treatment by radiotherapy; * implementation of a systemic therapy such as chemotherapy
Overall survival	5 years	Time from randomization to death from any cause
Progression-free survival	5 years	Time from randomization to first oncological event (progression/relapse) or death from any cause.
5-year compliance to the customized surveillance plan	5 years	Compliance is defined by completion of all scheduled examinations (telephone contact, biological, clinical examination and imaging examination) with a margin of + or - 30 days from the scheduled date
Description of the use of care	5 years	* number of physical consultations at the investigator site; * number of emergency room visits for oncological reasons; * number of extra-hospital consultations for oncological reasons
Drop-out rate	5 years	Rate of patients lost to follow-up or quitting the surveillance program
Support care needs identified	2 years (early termination in case of relapse of the disease)	Support care needs include : * algology consultation; * nutrition/diet consultation; * psycho-oncology consultation; * social worker consultation; * job retention consultation

Trial Locations

Locations (3)

Centre François Baclesse; 🇫🇷 Caen, France

CHU Amiens; 🇫🇷 Amiens, France

Centre Oscar Lambret; 🇫🇷 Lille, France