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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neuroendocrine (NE) Tumors; Therapeutic Education Program; Oral Anti-Tumor Drugs
• Intervention / Treatment: Other: Questionnaires

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Laura Dr Gerard; Phone Number: +33472119167; Email: laura.gerard@chu-lyon.fr
• Study Contact Backup: Name: Thomas Dr Walter; Phone Number: +33472117398; Email: thomas.walter@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69003
    • Edouard Herriot University Hospital
    • Contact: Laura Dr Gerard; Phone Number: +33472119167; Email: laura.gerard@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Recruitment will be carried out among patients hospitalized in the Medical Oncology department at Edouard Herriot University Hospital.

Every consecutive patient with an indication for oral anti-tumor agents (ATO) within the context of a neuroendocrine tumor (NET) will be screened and included in the study in the absence of contraindications and after obtaining their non-opposition.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients enrolled in the therapeutic education program; Patient with a neuroendocrine tumor requiring treatment with oral antitumor therapy	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.
Patients not enrolled in the therapeutic education program; Patient with a neuroendocrine tumor requiring treatment with oral antitumor therapy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Adverse effects (CTCAE v5.0) within 3 months following the initiation of ATO Grade 3-4 and 5 adverse effects: hematological, digestive, cutaneous, renal, hepatic toxicity (cytolysis >5x normal), cardiovascular (including arterial hypertension and thromboembolic complications), pulmonary (interstitial lung disease), metabolic (including hyperglycemia, lipid profile abnormalities); Actions taken at Month 1 and Month 3 Treatment suspension or delay of the cycle: number of suspensions, duration of suspension (in days) or number of cycle delays, duration of delay (in days) Dose reduction: reduction (yes/no), new dose Hospitalization due to adverse effects: number of hospitalizations, duration (total number of hospitalization days); Description of patient follow-up and therapeutic patient education program Number of consultations: teleconsultation or in-person consultation, with nurse or physician (general practitioner or oncologist) Number of phone calls: with nurse or physician	at 3 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Laura Gerard, Dr, Medical Oncology Department

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life; Tolerance; Neuroendocrine tumor; Oral Anti-Tumor Drugs; Therapeutic Education Program
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplasms; Neuroendocrine Tumors; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 69HCL25_0703; 2025-A01985-44 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No