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

Primary Purpose

Stage I Testicular Seminoma, Stage I Testicular Nonseminomatous Germ Cell Tumor, Gastrointestinal Stromal Tumors

Status
Not yet recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Oncological Follow-up
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stage I Testicular Seminoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens
  • Centre François Baclesse
  • Centre Oscar Lambret

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental

Control

Arm Description

Telesurveillance by a nurse

On-site surveillance by a hospital physician

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Drop-out rate
Rate of patients lost to follow-up or quitting the surveillance program
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
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
Progression-free survival
Time from randomization to first oncological event (progression/relapse) or death from any cause.
Overall survival
Time from randomization to death from any cause
Support care needs identified
Support care needs include : algology consultation nutrition/diet consultation psycho-oncology consultation social worker consultation job retention consultation

Full Information

First Posted
August 10, 2022
Last Updated
February 7, 2023
Sponsor
Centre Oscar Lambret
Collaborators
Canceropôle Nord Ouest, Groupement Interrégional de Recherche Clinique et d'Innovation
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1. Study Identification

Unique Protocol Identification Number
NCT05500391
Brief Title
Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
Canceropôle Nord Ouest, Groupement Interrégional de Recherche Clinique et d'Innovation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Telesurveillance by a nurse
Arm Title
Control
Arm Type
Other
Arm Description
On-site surveillance by a hospital physician
Intervention Type
Other
Intervention Name(s)
Oncological Follow-up
Intervention Description
Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)
Primary Outcome Measure Information:
Title
2-year compliance to the customized surveillance plan
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
5-year compliance to the customized surveillance plan
Description
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
Time Frame
5 years
Title
Drop-out rate
Description
Rate of patients lost to follow-up or quitting the surveillance program
Time Frame
5 years
Title
Description of the use of care
Description
number of physical consultations at the investigator site number of emergency room visits for oncological reasons number of extra-hospital consultations for oncological reasons
Time Frame
5 years
Title
Occurrence and management of oncological events
Description
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
Time Frame
5 years
Title
Progression-free survival
Description
Time from randomization to first oncological event (progression/relapse) or death from any cause.
Time Frame
5 years
Title
Overall survival
Description
Time from randomization to death from any cause
Time Frame
5 years
Title
Support care needs identified
Description
Support care needs include : algology consultation nutrition/diet consultation psycho-oncology consultation social worker consultation job retention consultation
Time Frame
2 years (early termination in case of relapse of the disease)
Other Pre-specified Outcome Measures:
Title
Costs in terms of medical transport use
Description
Medical transport includes light medical vehicles and ambulances
Time Frame
5 years
Title
Salary mass mobilized from a hospital perspective in both arms
Description
Salary mass mobilized from a hospital perspective in both arms
Time Frame
5 years
Title
Patient satisfaction
Description
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
Time Frame
2 years
Title
Patient reported outcomes
Description
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.
Time Frame
2 years
Title
Evaluation of the causes of recruitment failures
Description
In each investigating site, a screening log will be completed to find out the reasons for recruitment failures
Time Frame
During the recruiting period (18 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: Desmoid fibromatosis of the abdominal wall operated on or under active surveillance Stage I testicular seminoma (whether or not treated with carboplatin AUC7) Stage I non-seminomatous germ cell tumor (with or without adjuvant BEP chemotherapy) Operated GIST with low risk of relapse 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 Low-grade glioma, operated 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurence ROTSAERT
Phone
0320295860 / 0320295918
Email
l-rotsaert@o-lambret.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fanny BEN OUNE
Phone
0320295918
Ext
+33
Email
f-benoune@o-lambret.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PENEL Nicolas, MD, PhD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume BONNET
Email
bonnet.guillaume@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Guillaume BONNET
First Name & Middle Initial & Last Name & Degree
Mathieu BOONE, MD
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François GERNIER
Email
f.gernier@baclesse.unicancer.fr
First Name & Middle Initial & Last Name & Degree
François GERNIER
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence ROTSAERT
Email
l-rotsaert@o-lambret.fr
First Name & Middle Initial & Last Name & Degree
Laurence ROTSAERT
First Name & Middle Initial & Last Name & Degree
Nicolas PENEL, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20429948
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.
Results Reference
background
PubMed Identifier
31280494
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.
Results Reference
background
PubMed Identifier
30093916
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.
Results Reference
background
PubMed Identifier
34922758
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.
Results Reference
background
PubMed Identifier
32429987
Citation
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.
Results Reference
background

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

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