Awareness and Attitude of Cancer Patients About Participation in Clinical Research (CR) in Saudi Arabia

Enrollment of patients in CR may be impacted by their levels of awareness and attitude toward participation. Our study aims at assessing the awareness and willingness to participate in CR and identifying the barriers and influencing factors for participation.

A cross-sectional study was performed using an interview-based questionnaire composed of close-ended questions conducted by trained research coordinators. Descriptive statistics, univariate and multivariate analyses were applied.

Study Overview

• Status: Completed
• Conditions: Oncology [See Also, Affected System]

Detailed Description

Clinical Trials are essential for the identification of effective therapies in modern medicine. As the biomedical understanding of diseases increases, a growing number of new opportunities will require increasing numbers of patients agreeing to participate in a clinical trial

Public awareness about the need for clinical research and the benefit beyond participation is important. Although the main objective of clinical trials is to provide a high standard of care and help in advancement of medical knowledge, only a small portion of patients receive treatment as part of a formal clinical trial

Misconceptions about clinical trials are frequent, primarily due to lack of adequate information from the treating physician; the complexity of the study procedure; preferences of patients regarding a particular treatment or no treatment; uncertainty and the experimental nature of a clinical trial (additional side effects, less known about the treatment) and concern about confidential information are some of the significant barriers to participation. Healthy individuals and patients do not have the same perception, since patients have stressed and vulnerable feelings after diagnosis of their illness having a negative impact on patient's attitude towards a trial.

The ability to recruit patients for future clinical trials will depend, in part, on understanding the barriers of participation in clinical trials. Unfortunately, there is no data about the public awareness and attitudes toward participation in clinical trials in Kingdom of Saudi Arabia. It is the purpose of this study to address this issue to create some baseline data to increase the accrual rate of clinical trials.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • King Abdul Aziz Medical City for National Guard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study is planned to take place among Oncology patients ( inpatient and outpatient).

Description

Inclusion Criteria:

Adult patient (18 years and above) with cancer diagnosis. Adult patients who are treated services at King Abdulaziz Medical City (KAMC), National Guard Health Affairs(NGHA) Riyadh Willing to complete the survey questionnaire

Exclusion Criteria:

Patients who refuse to complete the survey questionnaire

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Survey; Cross-sectional survey will be carried out using an interview questionnaire composed of close-ended questions to be completed by trained research coordinator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the awareness and attitudes	To study the Awareness and Attitudes of Saudi adult cancer patients towards participation in clinical research.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess knowledge	To assess the knowledge of cancer patients about the clinical research process. To assess cancer patients willingness to participate in clinical research. To identify the patients barriers to clinical research participation.	2 years

Collaborators and Investigators

• Sponsor: National Guard Health Affairs
• Investigators: Principal Investigator: Nagham RZ Sheblaq, CCRP, King Abdul Aziz Medical City for National Guard

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: January 15, 2014
• First Submitted That Met QC Criteria: January 19, 2014
• First Posted (Estimate): January 22, 2014

Study Record Updates

• Last Update Posted (Estimate): January 22, 2014
• Last Update Submitted That Met QC Criteria: January 19, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: awareness, clinical research, Saudi arabia
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: awareness