Clinical trial NCT02042469: Awareness and Attitude of Cancer Patients About Participation in Clinical Research (CR) in Saudi Arabia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oncology [See Also, Affected System]
Keywords: awareness, clinical research, Saudi arabia
Lead sponsor: National Guard Health Affairs
Sponsor class: OTHER_GOV
First posted: 2014-01-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is planned to take place among Oncology patients ( inpatient and outpatient).

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure the awareness and attitudes
timeFrame: 2 years
Secondary outcomes:
measure: assess knowledge
timeFrame: 2 years
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Abdul Aziz Medical City for National Guard
Study officials:
affiliation: King Abdul Aziz Medical City for National Guard
name: Nagham RZ Sheblaq, CCRP
role: PRINCIPAL_INVESTIGATOR
References: