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

Glioma Clinical Trial

— SUR-CAN  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05500391
• Other study ID #: SUR-CAN-2201
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma, Mucinous
• Carcinoma, Small Cell
• Carcinosarcoma
• Carcinosarcoma, Ovarian
• Cystadenocarcinoma
• Fibroma
• Gastrointestinal Stromal Tumors
• Glioma
• Neoplasms, Germ Cell and Embryonal
• Neuroendocrine Tumors
• Ovarian Germ Cell Tumor
• Seminoma
• Stage I Testicular Seminoma

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)