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

NCT ID: NCT07258810

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients enrolled in the therapeutic education program

Patient with a neuroendocrine tumor requiring treatment with oral antitumor therapy

Questionnaires

Intervention Type 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 not enrolled in the therapeutic education program

Patient with a neuroendocrine tumor requiring treatment with oral antitumor therapy

Questionnaires

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Gerard, Dr

Role: PRINCIPAL_INVESTIGATOR

Medical Oncology Department

Locations

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Edouard Herriot University Hospital

Lyon, , France

Site Status

Countries

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France

Central Contacts

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Laura Dr Gerard

Role: CONTACT

+33472119167

Thomas Dr Walter

Role: CONTACT

+33472117398

Facility Contacts

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Laura Dr Gerard

Role: primary

+33472119167

Other Identifiers

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2025-A01985-44

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL25_0703

Identifier Type: -

Identifier Source: org_study_id

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