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NCT06120335 Clinical Trial

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

Cancer Clinical Trial

Official title:
Development and Reliability and Validity Evaluation of a Scale for Cancer Patients' Willingness to Voluntarily Participate in Drug Clinical Trials

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06120335
Other study ID # SYSKY-2023-1029-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 9, 2023
Est. completion date September 1, 2024

Study information
Verified date January 2024
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact Caie Chen
Phone 18707657343
Email chence3@mail2.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date September 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
China Sun Yat-sen Memorial Hospital Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary A semi-structured interview 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. 3 months
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