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

Phase 2RecruitingNCT05500391

Centre Oscar Lambret88 enrolled

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Stage I Testicular Seminoma Stage I Testicular Nonseminomatous Germ Cell Tumor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 2 years

Secondary Outcomes

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

Time frame: 5 years

Drop-out rate

Rate of patients lost to follow-up or quitting the surveillance program

Time frame: 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

Time frame: 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

Time frame: 5 years

Progression-free survival

Time from randomization to first oncological event (progression/relapse) or death from any cause.

Time frame: 5 years

Overall survival

Time from randomization to death from any cause

Time frame: 5 years

Support care needs identified

Support care needs include : * algology consultation * nutrition/diet consultation * psycho-oncology consultation * social worker consultation * job retention consultation

Time frame: 2 years (early termination in case of relapse of the disease)

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

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts