Adenocarcinoma, Clear Cell, Aggressive Fibromatosis of Abdominal Wall (Disorder), Borderline Ovarian Tumor, Carcinoma, Small Cell, Carcinosarcoma, Ovarian, Gastrointestinal Stromal Tumors, Glioma, Mucinous Adenocarcinoma of Ovary, Neuroendocrine Tumors, Ovarian Germ Cell Tumor, Serous Tumor of Ovary, Sex Cord-Stromal Tumor, Stage I Testicular Nonseminomatous Germ Cell Tumor, Stage I Testicular Seminoma
Conditions
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
Interventions
OTHEROncological Follow-up
Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)
Sponsors
Centre Oscar Lambret
Canceropôle Nord Ouest
Groupement Interrégional de Recherche Clinique et d'Innovation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Drop-out rate | 5 years | Rate of patients lost to follow-up or quitting the surveillance program |
| 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 |
| 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 |
| Progression-free survival | 5 years | Time from randomization to first oncological event (progression/relapse) or death from any cause. |
| Overall survival | 5 years | Time from randomization to death from any cause |
| 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 |
Countries
France
Contacts
CONTACTLaurence ROTSAERT
CONTACTFanny BEN OUNE
PRINCIPAL_INVESTIGATORPENEL Nicolas, MD, PhD
Centre Oscar Lambret
Outcome results
None listed