Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oncological Follow-up.
- Who it may be relevant to
- Registry conditions: Stage I Testicular Seminoma, Stage I Testicular Nonseminomatous Germ Cell Tumor, Gastrointestinal Stromal Tumors, Ovarian Germ Cell Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Interventions
- Other Oncological Follow-up
Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)
Primary outcome measures
- 2-year compliance to the customized surveillance plan [Time frame: 2 years]
Secondary outcome measures (7)
- 5-year compliance to the customized surveillance plan [Time frame: 5 years]
- Drop-out rate [Time frame: 5 years]
- Description of the use of care [Time frame: 5 years]
- Occurrence and management of oncological events [Time frame: 5 years]
- Progression-free survival [Time frame: 5 years]
- Overall survival [Time frame: 5 years]
- Support care needs identified [Time frame: 2 years (early termination in case of relapse of the disease)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
France · 3 centers
- CHU Amiens — Amiens
- Centre François Baclesse — Caen
- Centre Oscar Lambret — Lille
Publications
- 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. PMID 20429948
- 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. PMID 31280494
- 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. PMID 30093916
- 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. PMID 34922758
- 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. PMID 32429987
Identifiers
NCT: NCT05500391 · SUR-CAN-2201 · 2022-A01482-41