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

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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05500391
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Centre Oscar Lambret
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	PENEL Nicolas, MD, PhD
Principal Investigator Affiliation	Centre Oscar Lambret
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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)

Additional Details

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

Arms & Interventions

Arms

Experimental: Experimental

Telesurveillance by a nurse

Other: Control

On-site surveillance by a hospital physician

Interventions

Other: - Oncological Follow-up

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.