Comparing in-person and remote monitoring for cancer follow-up
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 study is testing whether patients with rare tumors follow their post-treatment care plans better with in-person visits from a doctor or remote check-ins with a nurse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Oscar Lambret Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Amiens and 2 other locations) |
| Trial ID | NCT05500391 on ClinicalTrials.gov |
What this trial studies
This multicenter, interventional study aims to evaluate compliance with personalized post-treatment surveillance plans for patients diagnosed with rare tumors within the last 12 months. Participants will be randomly assigned to receive follow-up care either in person by a physician or remotely by a trained nurse. The primary objective is to compare 2-year compliance rates between the two groups, while secondary objectives include long-term compliance, care utilization, and management of oncological events. Exploratory objectives will assess costs, patient satisfaction, psychological well-being, and reasons for recruitment failures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with specific rare tumors within the last 12 months.
Not a fit: Patients who are unable to undergo the required imaging tests or do not have access to telemedicine may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient compliance with follow-up care, potentially improving outcomes for those with rare tumors.
How similar studies have performed: Other studies have shown promise in remote monitoring approaches, but this specific comparison of in-person versus remote follow-up in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amiens and 2 other locations
- CHU Amiens — Amiens, France (Not_yet_recruiting)
- Centre François Baclesse — Caen, France (Not_yet_recruiting)
- Centre Oscar Lambret — Lille, France (Recruiting)
Study contacts
- Principal investigator: PENEL Nicolas, MD, PhD — Centre Oscar Lambret
- Study coordinator: Laurence ROTSAERT
- Email: l-rotsaert@o-lambret.fr
- Phone: 0320295860 / 0320295918
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.