Analysis of the Determinants of the Participation of Patients and Health Professionals of the University Hospital Center of Martinique in Clinical Research Protocols in Medical Oncology (StudyOrec)

NCT07206927 | Not Yet Recruiting

• 2 other identifiers: 24_RIPH3-042025-A01419-40
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

For optimal patient care, it is imperative that healthcare professionals implement appropriate strategies. These strategies must take into account changes in healthcare practices associated with advances in medications and medical equipment. Clinical trials play a crucial role in validating the efficacy and safety of these advances, ensuring high-quality and constantly improving healthcare. However the proportion of patients included in therapeutic trials is often considered too low. Several ideas have been explored to explain the low participation rate in research projects. These are closely linked to research actors and tools, such as, for example:

• the research protocol and its eligibility criteria, which may be overly strict
• healthcare professionals with the barriers encountered in carrying out research programs (motivation, attitude and perceptions, human, logistical and technical constraints, lack of training)
• patients who are generally poorly acculturated to clinical research, the lack of information for patients in healthcare services, and patients' lack of trust in the healthcare system.
• ... In Martinique, healthcare professionals face the same challenges in including patients in clinical trials. Patient inclusion is necessary due to the region's demographic and medical characteristics. To improve patient inclusion in these trials, it is important to define the human and material barriers and levers that influence the participation of patients and healthcare professionals in clinical research protocols in the medical oncology departments of the Martinique University Hospital. The investigators believe that increased patient awareness of the benefits of clinical research, equally increased incentives for healthcare professionals, and the establishment of adequate support structures would increase participation in clinical research protocols within the medical oncology departments of the Martinique University Hospital. By conducting a mixed qualitative and quantitative study to gather the perspectives of patients and caregivers, the investigators aim to identify the human and material barriers that limit the participation of oncology patients in Martinique.

Conditions

Oncologic Diseases; Cancer; Oncology

Keywords

clinical research participation; investigation; interrogation; barriers and levers of participation; questionnaire

Outcome Measures

Primary Outcomes (2)

• Qualitative study with patients: questioning the participation of patients from the services involved in medical oncology at the Martinique University Hospital in clinical research projects and identifying the obstacles and levers to this participation.

  A semi-structured interview, lasting 20 to 30 minutes, will be conducted by the sociologist and anthropologist. They will use questionnaires (semi-structured interview grids), administered to patients face-to-face or by telephone. Patients will be interviewed only once. The interview grid includes the following sections: personal characteristics such as age, family and professional situation, municipality of residence, and knowledge of clinical research.

  6 months

• Quantitative study among professionals: measure the proportion of healthcare professionals of CHU of Martinique who have already participated in clinical research projects or agreed to participate in them treating patients with medical oncology needs.

  Questionnaires will be administered by email, in a single session, to healthcare professionals who have agreed to participate in the study.

  3 months

Secondary Outcomes (2)

• Qualitative patient study: Research the existence of factors associated with patient participation such as age, gender, socio-professional category, etc.

  6 months

• Quantitative study among professionals: Measure the importance of identified barriers and enablers for participating in clinical research projects among healthcare professionals in the medical oncology departments of the Martinique University Hospital.

  3 months

Study Arms (2)

Qualitative Study : Patients interviews

For the qualitative part, 30 patients will be included in the study. A semi-structured interview, lasting 20 to 30 minutes, will be conducted by the sociologist and anthropologist. They will use questionnaires (semi-structured interview grids), administered to patients face-to-face or by telephone. Patients will be interviewed only once. The interview grid includes the following sections: personal characteristics such as age, family and professional situation, municipality of residence, and knowledge of clinical research.

Other: Qualitative Study: Semi-structured interview for patients

Quantitative Study : Healthcare professionals questionnaires

For the qualitative part, 30 healthcare professionnals will be included in the study. Questionnaires will be administered by email, in a single session, to healthcare professionals who have agreed to participate in the study.

Other: Quantitative Study : Healthcare professionals questionnaires

Interventions

Qualitative Study: Semi-structured interview for patients OTHER

A semi-structured interview, lasting 20 to 30 minutes, will be conducted by the sociologist and anthropologist. They will use questionnaires (semi-structured interview grids), administered to patients face-to-face or by telephone. Patients will be interviewed only once. The interview grid includes the following sections: personal characteristics such as age, family and professional situation, municipality of residence, and knowledge of clinical research.

Qualitative Study : Patients interviews

Quantitative Study : Healthcare professionals questionnaires OTHER

Questionnaires will be administered by email, in a single session, to healthcare professionals who have agreed to participate in the study.

Quantitative Study : Healthcare professionals questionnaires

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Patient being treated for cancer at the University Hospital Center of Martinique. * Qualified healthcare professional working in the medical oncology departments of the University Hospital Center of Martinique.

You may qualify if:

• Male or female,
• Age ≥ 18 years,
• Patient being treated for cancer at the University Hospital Center of Martinique,
• Patient who can read and/or understand French,
• Patient who has consented to the use of their medical data for this research.
• \- Any qualified healthcare professional working in the medical oncology departments of the University Hospital Center of Martinique, such as oncologists, radiation therapists, urologists, nurses, etc.

You may not qualify if:

• Patient with known cognitive impairments that prevent them from completing the questionnaire,
• Subjects under legal protection (guardianship/curatorship),
• Subjects at an advanced stage of the disease (asthenia),
• Written or oral objection from the patient to the use of data for research purposes.
• Students in training regardless of their field,
• Replacement healthcare professionals for a period of less than 12 months.

Sponsors & Collaborators

• University Hospital Center of Martinique: lead
• KaFE Association (Karaib Formation Etudes): collaborator

Study Sites (1)

University Hospital Center of Martinique

Fort-de-France, 97261, Martinique

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Mickaëlle ROSE

  University Hospital Center of Martinique

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mickaëlle ROSE

CONTACT

05 96 59 26 23; Mickaelle.Rose@chu-martinique.fr

Study Design

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

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)