Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05500391
Other study ID # SUR-CAN-2201
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 28, 2024
Est. completion date October 2029

Study information

Verified date March 2024
Source Centre Oscar Lambret
Contact Laurence ROTSAERT
Phone 0320295860 / 0320295918
Email l-rotsaert@o-lambret.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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


Recruitment information / eligibility

Status Recruiting
Enrollment 88
Est. completion date October 2029
Est. primary completion date October 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Other:
Oncological Follow-up
Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)

Locations

Country Name City State
France CHU Amiens Amiens
France Centre François Baclesse Caen
France Centre Oscar Lambret Lille

Sponsors (3)

Lead Sponsor Collaborator
Centre Oscar Lambret Canceropôle Nord Ouest, Groupement Interrégional de Recherche Clinique et d'Innovation

Country where clinical trial is conducted

France, 

References & Publications (5)

Ferrua M, Minvielle E, Fourcade A, Lalloue B, Sicotte C, Di Palma M, Mir O. How to Design a Remote Patient Monitoring System? A French Case Study. BMC Health Serv Res. 2020 May 19;20(1):434. doi: 10.1186/s12913-020-05293-4. — View Citation

Keshava HB, Tan KS, Dycoco J, Huang J, Berkowitz A, Sumner D, Devigne A, Adusumilli P, Bains M, Bott M, Isbell J, Downey R, Molena D, Park B, Rocco G, Sihag S, Jones DR, Rusch VW. Long-term assessment of efficacy with a novel Thoracic Survivorship Program for patients with lung cancer. J Thorac Cardiovasc Surg. 2022 May;163(5):1645-1653.e4. doi: 10.1016/j.jtcvs.2021.11.026. Epub 2021 Nov 20. — View Citation

Kimman ML, Bloebaum MM, Dirksen CD, Houben RM, Lambin P, Boersma LJ. Patient satisfaction with nurse-led telephone follow-up after curative treatment for breast cancer. BMC Cancer. 2010 Apr 30;10:174. doi: 10.1186/1471-2407-10-174. — View Citation

Martin E, Persaud S, Corr J, Casey R, Pillai R. Nurse-led active surveillance for prostate cancer is safe, effective and associated with high rates of patient satisfaction-results of an audit in the East of England. Ecancermedicalscience. 2018 Jul 25;12:854. doi: 10.3332/ecancer.2018.854. eCollection 2018. — View Citation

Moloney J, Partridge C, Delanty S, Lloyd D, Nguyen MH. High efficacy and patient satisfaction with a nurse-led colorectal cancer surveillance programme with 10-year follow-up. ANZ J Surg. 2019 Oct;89(10):1286-1290. doi: 10.1111/ans.15333. Epub 2019 Jul 7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Costs in terms of medical transport use Medical transport includes light medical vehicles and ambulances 5 years
Other Salary mass mobilized from a hospital perspective in both arms Salary mass mobilized from a hospital perspective in both arms 5 years
Other Patient satisfaction Patients will answer a satisfaction survey (French Version of the Princess Margaret Hospital Satisfaction With Doctor) at different points of the study depending on their pathology 2 years
Other Patient reported outcomes Patient reported outcomes will be evaluated using the Hospital Anxiety and Depression Scale (HADS) questionnaire at different points of the study depending on their pathology.
The questionnaire consists of a list of questions to determine the level of anxiety and depression experienced by the patients. Each question is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression:
A score equal to or less than 7 indicates no symptoms, A score of 8 - 10 indicates a questionable symptoms, A score of 11 and above confirms of the presence of anxiety and/or depression symptoms.
2 years
Other Evaluation of the causes of recruitment failures In each investigating site, a screening log will be completed to find out the reasons for recruitment failures During the recruiting period (18 months)
Primary 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 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
Secondary Drop-out rate Rate of patients lost to follow-up or quitting the surveillance program 5 years
Secondary 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
Secondary 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
Secondary Progression-free survival Time from randomization to first oncological event (progression/relapse) or death from any cause. 5 years
Secondary Overall survival Time from randomization to death from any cause 5 years
Secondary 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)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04539574 - An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors N/A
Enrolling by invitation NCT04461002 - Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of Incident WHO II and III Grade Gliomas.
Terminated NCT01902771 - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors Phase 1
Completed NCT03242824 - The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma Phase 2
Recruiting NCT04186832 - Step Count Monitoring as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Undergoing Radiation Therapy N/A
Completed NCT00424554 - Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed) Phase 2
Recruiting NCT05968053 - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Not yet recruiting NCT04550663 - NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors Phase 1
Completed NCT02805179 - A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma Phase 2
Terminated NCT04556929 - Enhanced Detection in Glioma Excision N/A
Not yet recruiting NCT06408428 - Glioma Intraoperative MicroElectroCorticoGraphy N/A
Recruiting NCT06043232 - MMR/MSI Phenotypes in Prediction of Tumor Vaccine Benefit for Gliomas
Not yet recruiting NCT06043765 - Reducing Cognitive Impairment in Glioma With Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training N/A
Not yet recruiting NCT05025969 - Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours
Completed NCT02978261 - Study of a c-Met Inhibitor PLB1001 in Patients With PTPRZ1-MET Fusion Gene Positive Recurrent High-grade Gliomas Phase 1
Terminated NCT01502605 - Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas Phase 1
Completed NCT01836536 - Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients N/A
Completed NCT01479686 - iMRI Guided Resection in Cerebral Glioma Surgery Phase 3
Completed NCT01212731 - Skull Base and Low Grade Glioma Neurocognitive Magnetic Resonance Imaging (MRI) Study
Withdrawn NCT00985036 - Vascular Endothelial Growth Factor (VEGF) Levels in Brain Tumor Patients N/A