Development of a Scale for Cancer Patients' Willingness to Voluntarily Participate in Drug Clinical Trials

Recruiting

• Conditions: Cancer

• Registration Number: NCT06120335
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

The goal of this observational study is to develop a scale for cancer patients' willingness to voluntarily participate in drug clinical trials and evaluate its reliability and validity.

Detailed Description

Inclusion Criteria:

1. Age 18-80 years old (including boundary values).

2. Tumor patients with clear diagnosis.

3. Whether they finally sign the informed consent form of one drug clinical trial or not, and whether they are finally enrolled in one drug clinical trial or not, patients who have undergone the informed consent process of drug clinical trials conducted by clinicians can be enrolled in this study.

4. Volunteer to participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Patients with unclear consciousness.

2. Patients who are unable to correctly understand and answer questions.

3. Vulnerable subjects include: students and subordinates of researchers, military personnel, prisoners, patients with incurable diseases, patients in critical situations, those admitted to welfare institutions, homeless individuals, minors, and those who are unable to provide informed consent.

Study Timeline

• Study First Submitted: 2023-11-02
• Study First Submitted QC: 2023-11-06
• Study First Posted: 2023-11-07
• Study Start: 2023-11-09
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-24
• Primary Completion: 2024-06-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age 18-80 years old (including boundary values).
2. Tumor patients with clear diagnosis.
3. Whether they finally sign the informed consent form of one drug clinical trial or not, and whether they are finally enrolled in one drug clinical trial or not, patients who have undergone the informed consent process of drug clinical trials conducted by clinicians can be enrolled in this study.
4. Volunteer to participate in this study and sign an informed consent form.

Exclusion Criteria

1. Patients with unclear consciousness.
2. Patients who are unable to correctly understand and answer questions.
3. Vulnerable subjects include: students and subordinates of researchers, military personnel, prisoners, patients with incurable diseases, patients in critical situations, those admitted to welfare institutions, homeless individuals, minors, and those who are unable to provide informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A semi-structured interview	3 months	A semi-structured interview is conducted to investigate the willingness of cancer patients to participate in drug clinical trials and its influencing factors. The researcher will analyze the interview results and summarize several themes that reflect the willingness.

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital; 🇨🇳 Guangzhou, Guangdong, China