Glioma Clinical Trial
— SUR-CANOfficial title:
Randomized Phase II Trial Evaluating Compliance With Monitoring Conducted Either by a Hospital-based Physician in Person or by a Nurse in Remote Monitoring
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).
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Amiens | Amiens | |
France | Centre François Baclesse | Caen | |
France | Centre Oscar Lambret | Lille |
Lead Sponsor | Collaborator |
---|---|
Centre Oscar Lambret | Canceropôle Nord Ouest, Groupement Interrégional de Recherche Clinique et d'Innovation |
France,
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
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) |
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