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Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring (SUR-CAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05500391
Recruitment Status : Not yet recruiting
First Posted : August 15, 2022
Last Update Posted : August 15, 2022
Sponsor:
Collaborators:
Canceropôle Nord Ouest
Groupement Interrégional de Recherche Clinique et d'Innovation
Information provided by (Responsible Party):
Centre Oscar Lambret

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).

Condition or disease Intervention/treatment Phase
Stage I Testicular Seminoma Stage I Testicular Nonseminomatous Germ Cell Tumor Gastrointestinal Stromal Tumors Ovarian Germ Cell Tumor Adenocarcinoma, Clear Cell Borderline Ovarian Tumor Sex Cord-Stromal Tumor Mucinous Adenocarcinoma of Ovary Carcinoma, Small Cell Carcinosarcoma, Ovarian Serous Tumor of Ovary Glioma Neuroendocrine Tumors Aggressive Fibromatosis of Abdominal Wall (Disorder) Other: Oncological Follow-up Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Estimated Study Start Date : January 2023
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : June 2029


Arm Intervention/treatment
Experimental: Experimental
Telesurveillance by a nurse
Other: Oncological Follow-up
Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)

Control
On-site surveillance by a hospital physician
Other: Oncological Follow-up
Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)




Primary Outcome Measures :
  1. 2-year compliance to the customized surveillance plan [ Time Frame: 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 Outcome Measures :
  1. 5-year compliance to the customized surveillance plan [ Time Frame: 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

  2. Drop-out rate [ Time Frame: 5 years ]
    Rate of patients lost to follow-up or quitting the surveillance program

  3. Description of the use of care [ Time Frame: 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

  4. Occurrence and management of oncological events [ Time Frame: 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

  5. Progression-free survival [ Time Frame: 5 years ]
    Time from randomization to first oncological event (progression/relapse) or death from any cause.

  6. Overall survival [ Time Frame: 5 years ]
    Time from randomization to death from any cause

  7. Support care needs identified [ Time Frame: 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


Other Outcome Measures:
  1. Costs in terms of medical transport use [ Time Frame: 5 years ]
    Medical transport includes light medical vehicles and ambulances

  2. Salary mass mobilized from a hospital perspective in both arms [ Time Frame: 5 years ]
    Salary mass mobilized from a hospital perspective in both arms

  3. Patient satisfaction [ Time Frame: 2 years ]
    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

  4. Patient reported outcomes [ Time Frame: 2 years ]

    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.


  5. Evaluation of the causes of recruitment failures [ Time Frame: During the recruiting period (18 months) ]
    In each investigating site, a screening log will be completed to find out the reasons for recruitment failures



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05500391


Contacts
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Contact: Laurence ROTSAERT 0320295860 / 0320295918 l-rotsaert@o-lambret.fr
Contact: Fanny BEN OUNE 0320295918 ext +33 f-benoune@o-lambret.fr

Locations
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France
CHU Amiens
Amiens, France, 80054
Contact: Guillaume BONNET       bonnet.guillaume@chu-amiens.fr   
Principal Investigator: Guillaume BONNET         
Sub-Investigator: Mathieu BOONE, MD         
Centre François Baclesse
Caen, France, 14076
Contact: François GERNIER       f.gernier@baclesse.unicancer.fr   
Principal Investigator: François GERNIER         
Centre Oscar Lambret
Lille, France, 59020
Contact: Laurence ROTSAERT       l-rotsaert@o-lambret.fr   
Principal Investigator: Laurence ROTSAERT         
Sub-Investigator: Nicolas PENEL, MD         
Sponsors and Collaborators
Centre Oscar Lambret
Canceropôle Nord Ouest
Groupement Interrégional de Recherche Clinique et d'Innovation
Investigators
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Principal Investigator: PENEL Nicolas, MD, PhD Centre Oscar Lambret
Publications:
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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT05500391    
Other Study ID Numbers: SUR-CAN-2201
First Posted: August 15, 2022    Key Record Dates
Last Update Posted: August 15, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplasms, Germ Cell and Embryonal
Neuroendocrine Tumors
Gastrointestinal Stromal Tumors
Seminoma
Carcinosarcoma
Adenocarcinoma, Mucinous
Cystadenocarcinoma
Fibroma
Carcinoma, Small Cell
Fibromatosis, Aggressive
Sex Cord-Gonadal Stromal Tumors
Adenocarcinoma, Clear Cell
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroectodermal Tumors
Neoplasms, Nerve Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Germinoma
Neoplasms, Complex and Mixed
Sarcoma
Neoplasms, Cystic, Mucinous, and Serous
Neoplasms, Fibrous Tissue