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

Study Overview
=================
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

Official Title
-----------------
Randomized Phase II Trial Evaluating Compliance With Monitoring Conducted Either by a Hospital-based Physician in Person or by a Nurse in Remote Monitoring

Conditions
-----------------
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)

Intervention / Treatment
-----------------
* Other: Oncological Follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: Contraindication to imaging tests required for the surveillance plan No telephone Patient under guardianship or curatorship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Telesurveillance by a nurse | Other: Oncological Follow-up<br>* Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)<br>|
| Other: Control<br>On-site surveillance by a hospital physician | Other: Oncological Follow-up<br>* Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year compliance to the customized surveillance plan | 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 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year compliance to the customized surveillance plan | 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 | 5 years | 
| Drop-out rate | Rate of patients lost to follow-up or quitting the surveillance program | 5 years | 
| Description of the use of care | number of physical consultations at the investigator site number of emergency room visits for oncological reasons number of extra-hospital consultations for oncological reasons | 5 years | 
| Occurrence and management of oncological events | 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 | 5 years | 
| Progression-free survival | Time from randomization to first oncological event (progression/relapse) or death from any cause. | 5 years | 
| Overall survival | Time from randomization to death from any cause | 5 years | 
| Support care needs identified | Support care needs include : algology consultation nutrition/diet consultation psycho-oncology consultation social worker consultation job retention consultation | 2 years (early termination in case of relapse of the disease) |