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

NCT ID: NCT05500391

Condition: 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)

Conditions: Official terms:
Adenocarcinoma
Neuroendocrine Tumors
Neoplasms, Germ Cell and Embryonal
Gastrointestinal Stromal Tumors
Seminoma
Carcinosarcoma
Adenocarcinoma, Mucinous
Cystadenocarcinoma
Fibroma
Carcinoma, Small Cell
Fibromatosis, Aggressive
Sex Cord-Gonadal Stromal Tumors
Adenocarcinoma, Clear Cell

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Health Services Research

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Oncological Follow-up
Description: Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)
Arm group label: Control
Arm group label: Experimental

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

Criteria for 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: 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: CHU Amiens

Address:
City: Amiens
Zip: 80054
Country: France

Status: Not yet recruiting

Contact:
Last name: Guillaume BONNET
Email: bonnet.guillaume@chu-amiens.fr

Investigator:
Last name: Guillaume BONNET
Email: Principal Investigator

Investigator:
Last name: Mathieu BOONE, MD
Email: Sub-Investigator

Facility:
Name: Centre François Baclesse

Address:
City: Caen
Zip: 14076
Country: France

Status: Not yet recruiting

Contact:
Last name: François GERNIER
Email: f.gernier@baclesse.unicancer.fr

Investigator:
Last name: François GERNIER
Email: Principal Investigator

Facility:
Name: Centre Oscar Lambret

Address:
City: Lille
Zip: 59020
Country: France

Status: Recruiting

Contact:
Last name: Laurence ROTSAERT
Email: l-rotsaert@o-lambret.fr

Investigator:
Last name: Laurence ROTSAERT
Email: Principal Investigator

Investigator:
Last name: Nicolas PENEL, MD
Email: Sub-Investigator

Start date: February 28, 2024

Completion date: October 2029

Lead sponsor:
Agency: Centre Oscar Lambret
Agency class: Other

Collaborator:
Agency: Canceropôle Nord Ouest
Agency class: Other

Collaborator:
Agency: Groupement Interrégional de Recherche Clinique et d'Innovation
Agency class: Other

Source: Centre Oscar Lambret

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05500391

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