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Spots Global Cancer Trial Database for Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring

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Trial Identification

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

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 ID: NCT05500391

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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CHU Amiens, Amiens, , France

Centre François Baclesse, Caen, , France

Centre Oscar Lambret, Lille, , France

Contact Details

Name: PENEL Nicolas, MD, PhD

Affiliation: Centre Oscar Lambret

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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