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

NCT07258810 | Not Yet Recruiting

• 2 other identifiers: 69HCL25_07032025-A01985-44
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Neuroendocrine tumor; Oral Anti-Tumor Drugs; Therapeutic Education Program; Tolerance; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients enrolled in the therapeutic education program

Patient with a neuroendocrine tumor requiring treatment with oral antitumor therapy

Other: Questionnaires

Patients not enrolled in the therapeutic education program

Patient with a neuroendocrine tumor requiring treatment with oral antitumor therapy

Other: Questionnaires

Interventions

Questionnaires OTHER

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 enrolled in the therapeutic education program; Patients not enrolled in the therapeutic education program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Edouard Herriot University Hospital

Lyon, 69003, France

Location

MeSH Terms

Conditions

Neoplasms; Neuroendocrine Tumors

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Laura Gerard, Dr

  Medical Oncology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Dr Gerard

CONTACT

+33472119167; laura.gerard@chu-lyon.fr

Thomas Dr Walter

CONTACT

+33472117398; thomas.walter@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 2, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

FR (1)