Oncology [See Also, Affected System]NCT02042469
Awareness and Attitude of Cancer Patients About Participation in Clinical Research (CR) in Saudi Arabia
An observational study of Oncology [See Also, Affected System], run by National Guard Health Affairs at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Oncology [See Also, Affected System]
- How many people
- 300 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Apr 2011to May 2013
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study is planned to take place among Oncology patients ( inpatient and outpatient).
Who may be able to join
- 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
Who cannot join
- Patients who refuse to complete the survey questionnaire
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdul Aziz Medical City for National Guard
Riyadh
About this study
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.
Read the 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.
- Conditions
- Oncology [See Also, Affected System]
- Keywords
- awareness, clinical research, Saudi arabia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Measure the awareness and attitudes
To study the Awareness and Attitudes of Saudi adult cancer patients towards participation in clinical research.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startApr 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncology [See Also, Affected System]Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- National Guard Health Affairs
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nagham RZ Sheblaq, CCRP, Principal investigator, King Abdul Aziz Medical City for National Guard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042469
- Sponsor's protocol ID
- Awareness
- Status last verified
- Jan 2014
- First submitted
- 15 Jan 2014
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awareness and Attitude of Cancer Patients About Participation in Clinical Research (CR) in Saudi Arabia
- ClinicalTrials.gov ID
- NCT02042469
- Acronym / sponsor ID
- Awareness
- Conditions
- Oncology [See Also, Affected System]
- Keywords
- awareness, clinical research, Saudi arabia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- National Guard Health AffairsOther government
- Study start
- Apr 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 22 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survey | – | –Cross-sectional survey will be carried out using an interview questionnaire composed of close-ended questions to be completed by trained research coordinator. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is planned to take place among Oncology patients ( inpatient and outpatient).
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who refuse to complete the survey questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure the awareness and attitudes
Time frame: 2 years
To study the Awareness and Attitudes of Saudi adult cancer patients towards participation in clinical research.
1 secondary outcome
assess knowledge
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagham RZ Sheblaq, CCRP principal investigator
King Abdul Aziz Medical City for National Guard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology [See Also, Affected System], run by National Guard Health Affairs at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the awareness and attitudes (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2014; AzTrials last refreshed its copy on 8 Nov 2026.