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

NCT ID: NCT05500391

Last Updated: 2025-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-28

Study Completion Date

2029-10-31

Brief Summary

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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

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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

Conditions

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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)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Experimental

Telesurveillance by a nurse

Group Type EXPERIMENTAL

Oncological Follow-up

Intervention Type OTHER

Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)

Control

On-site surveillance by a hospital physician

Group Type OTHER

Oncological Follow-up

Intervention Type OTHER

Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)

Interventions

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Oncological Follow-up

Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canceropôle Nord Ouest

OTHER

Sponsor Role collaborator

Groupement Interrégional de Recherche Clinique et d'Innovation

OTHER

Sponsor Role collaborator

Centre Oscar Lambret

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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PENEL Nicolas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Oscar Lambret

Locations

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CHU Amiens

Amiens, , France

Site Status NOT_YET_RECRUITING

Centre François Baclesse

Caen, , France

Site Status NOT_YET_RECRUITING

Centre Oscar Lambret

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Laurence ROTSAERT

Role: CONTACT

0320295860 / 0320295918

Fanny BEN OUNE

Role: CONTACT

0320295918 ext. +33

Facility Contacts

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Guillaume BONNET

Role: primary

François GERNIER

Role: primary

Laurence ROTSAERT

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 20429948 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31280494 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30093916 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34922758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32429987 (View on PubMed)

Other Identifiers

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SUR-CAN-2201

Identifier Type: -

Identifier Source: org_study_id

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