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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Caie Chen; Phone Number: 18707657343; Email: chence3@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-sen Memorial Hospital
      • Contact: Caie Chen; Phone Number: 18707657343; Email: chence3@mail2.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult tumor patients treated at Sun Yat sen Memorial Hospital at Sun Yat sen University

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: cancer patients; willingness; drug clinical trials
• Other Study ID Numbers: SYSKY-2023-1029-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No