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Not yet recruiting NCT07258810

Evaluation of Tolerance and Quality of Life in Patients With Neuroendocrine Tumors Treated With Oral Anti-Tumor Drugs Within a Therapeutic Education Program

Observational Neuroendocrine (NE) Tumors Oral Anti-Tumor Drugs Therapeutic Education Program

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: Questionnaires.
Who it may be relevant to
Registry conditions: Neuroendocrine (NE) Tumors, Oral Anti-Tumor Drugs, Therapeutic Education Program. 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 →

Overview

In recent years, the arrival of targeted oral therapies has greatly changed cancer treatment. These therapies help patients stay independent by reducing the number of hospital visits, since the treatment is given at home. However, this way of giving treatment brings specific challenges, especially in managing side effects and making sure patients follow their treatment properly. Because of this, many patient education programs have been created to help patients learn how to manage their treatment on their own. Although only a few studies have formally looked at how useful these programs are, the available information suggests that they help patients handle side effects better and follow their treatment more closely. Neuroendocrine tumors are a diverse group of tumors that are becoming more common. More patients with these tumors are now treated with targeted oral therapies such as everolimus, sunitinib, cabozantinib, or chemotherapy with temozolomide and capecitabine. These treatments are often given together with a patient education program. However, so far, no study has specifically looked at how helpful these education programs are for this group of patients.

Interventions

  • Other Questionnaires
    questionnaires given to patients in both groups: treatment adherence (MMAS-4 scale) at months 1 and 3, quality of life (EORTC QLQ-C30) at months 0, 1 and 3, and a satisfaction questionnaire developed and validated by the healthcare team and members of the French patient association for individuals with various neuroendocrine tumors (APTED) at month 3.

Primary outcome measures

  • Assessment of the incidence of grade 3 to 5 adverse events in patients with neuroendocrine tumors treated with oral anti-tumor agents (ATO), based on their participation in a therapeutic education program [Time frame: at 3 months]

Eligibility criteria

Inclusion criteria

  • Adult patient (>18 years) at the time of the study
  • Patient diagnosed with a neuroendocrine tumor (NET) with an indication for treatment with oral anti-tumor agents (everolimus, sunitinib, cabozantinib, temozolomide +/- capecitabine, others including lenvatinib)
  • Collection of the patient's non-opposition to participate in the study

Exclusion criteria

  • Minors
  • Pregnant, parturient, or breastfeeding women
  • Persons deprived of liberty by judicial or administrative decision
  • Adults under legal protection measures (guardianship, conservatorship)
  • Refusal to participate in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Edouard Herriot University Hospital — Lyon

Identifiers

NCT: NCT07258810 · 69HCL25_0703 · 2025-A01985-44

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗