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

March 19, 2024 updated by: Centre Oscar Lambret

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80054
        • Not yet recruiting
        • CHU Amiens
        • Contact:
        • Principal Investigator:
          • Guillaume BONNET
        • Sub-Investigator:
          • Mathieu BOONE, MD
      • Caen, France, 14076
      • Lille, France, 59020
        • Recruiting
        • Centre OSCAR LAMBRET
        • Contact:
        • Principal Investigator:
          • Laurence ROTSAERT
        • Sub-Investigator:
          • Nicolas PENEL, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years
Drop-out rate
Time Frame: 5 years
Rate of patients lost to follow-up or quitting the surveillance program
5 years
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
5 years
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 years
Progression-free survival
Time Frame: 5 years
Time from randomization to first oncological event (progression/relapse) or death from any cause.
5 years
Overall survival
Time Frame: 5 years
Time from randomization to death from any cause
5 years
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
2 years (early termination in case of relapse of the disease)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Costs in terms of medical transport use
Time Frame: 5 years
Medical transport includes light medical vehicles and ambulances
5 years
Salary mass mobilized from a hospital perspective in both arms
Time Frame: 5 years
Salary mass mobilized from a hospital perspective in both arms
5 years
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
2 years
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.
2 years
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
During the recruiting period (18 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Collaborators

Canceropôle Nord Ouest
Groupement Interrégional de Recherche Clinique et d'Innovation

Investigators

  • Principal Investigator: PENEL Nicolas, MD, PhD, Centre OSCAR LAMBRET

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

August 10, 2022

First Submitted That Met QC Criteria

August 12, 2022

First Posted (Actual)

August 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUR-CAN-2201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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