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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A01482-41 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Canceropôle Nord Ouest | OTHER |
| Groupement Interrégional de Recherche Clinique et d'Innovation | OTHER |
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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 :
The exploratory objectives are to :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Telesurveillance by a nurse |
|
| Control | Other | On-site surveillance by a hospital physician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oncological Follow-up | Other | Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition) |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Costs in terms of medical transport use | Medical transport includes light medical vehicles and ambulances | 5 years |
| Salary mass mobilized from a hospital perspective in both arms | Salary mass mobilized from a hospital perspective in both arms |
Inclusion Criteria:
Positive diagnosis (anatomopathology) of tumor within 12 months
Patient 18 years of age or older
Patient with one of the following conditions:
Patient who has given consent to participate in the study
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurence ROTSAERT | Contact | 0320295860 / 0320295918 | l-rotsaert@o-lambret.fr | |
| Fanny BEN OUNE | Contact | 0320295918 | +33 | f-benoune@o-lambret.fr |
| Name | Affiliation | Role |
|---|---|---|
| PENEL Nicolas, MD, PhD | Centre Oscar Lambret | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Not yet recruiting | Amiens | 80054 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20429948 | Background | 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. | |
| 31280494 | Background | 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. |
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Rate of patients lost to follow-up or quitting the surveillance program |
| 5 years |
| Description of the use of care |
| 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 :
| 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 :
| 2 years (early termination in case of relapse of the disease) |
| 5 years |
| 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 |
| 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 |
| 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) |
| Centre François Baclesse | Not yet recruiting | Caen | 14076 | France |
|
| Centre Oscar Lambret | Recruiting | Lille | 59020 | France |
|
| 30093916 | Background | 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. |
| 34922758 | Background | 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. |
| 32429987 | Background | 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. |
| ID | Term |
|---|---|
| D018239 | Seminoma |
| D046152 | Gastrointestinal Stromal Tumors |
| D018262 | Adenocarcinoma, Clear Cell |
| D018312 | Sex Cord-Gonadal Stromal Tumors |
| D018288 | Carcinoma, Small Cell |
| D002296 | Carcinosarcoma |
| D005910 | Glioma |
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D018237 | Germinoma |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018309 | Neoplasms, Gonadal Tissue |
| D018193 | Neoplasms, Complex and Mixed |
| D012509 | Sarcoma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009380 | Neoplasms, Nerve Tissue |
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