Cancer, Clinical TrialsNCT03231852
Patient Perceptions and Willingness to Enroll in Clinical Trials
An observational study of Cancer, Clinical Trials, run by University of Virginia at 1 site in United States.
Trial summary
The objective of our study is to determine which factors affect willingness to participate in gynecologic oncology clinical trials. Women with a diagnosis of gynecologic malignancy will be approached to complete a survey assessing willingness to participate in clinical trials. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer, Clinical Trials
- What is being tested?
- Survey
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2017to 1 May 2018
- 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 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All women presenting to the gynecologic oncology clinic meeting the inclusion/exclusion criteria will be approached to participate in this study.
Who may be able to join
- Diagnosis of gynecologic malignancy
- English or Spanish literate
Who cannot join
- Prior enrollment in a clinical trial
- Currently pregnant
- Currently incarcerated
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22902
About this study
The objective of our study is to determine which factors affect willingness to participate in gynecologic oncology clinical trials. Women with a diagnosis of gynecologic malignancy will be approached to complete a survey assessing willingness to participate in clinical trials. The validated Attitudes and Randomized Trials Questionnaire (ARTQ) will be used to assess willingness to participate.
- Conditions
- Cancer, Clinical Trials
- Being tested
- Survey
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Attitudes and Randomized Trial Questionnaire (ARTQ), Hospital Anxiety and Depression Scale, Perception Survey
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Women with a gynecologic malignancy will complete several surveys to assess their willingness to participate in clinical trials. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to Participate in Clinical Trials
Bivariate outcome derived from ARTQ survey
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start15 Jun 2017
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, Clinical TrialsStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda R Duska, University of Virginia
- Investigators
- Linda Duska, MD, MPH, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231852
- Sponsor's protocol ID
- 19844
- Status last verified
- Oct 2018
- First submitted
- 24 Jul 2017
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Perceptions and Willingness to Enroll in Clinical Trials
- ClinicalTrials.gov ID
- NCT03231852
- Acronym / sponsor ID
- 19844
- Conditions
- Cancer, Clinical Trials
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 27 Jul 2017 (actual)
- 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.
The objective of our study is to determine which factors affect willingness to participate in gynecologic oncology clinical trials. Women with a diagnosis of gynecologic malignancy will be approached to complete a survey assessing willingness to participate in clinical trials. The validated Attitudes and Randomized Trials Questionnaire (ARTQ) will be used to assess willingness to participate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | Other: SurveyWomen with a gynecologic malignancy will complete several surveys to assess their willingness to participate in clinical trials. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All women presenting to the gynecologic oncology clinic meeting the inclusion/exclusion criteria will be approached to participate in this study.
Key inclusion criteria (2 listed)
- Diagnosis of gynecologic malignancy
- English or Spanish literate
Key exclusion criteria (3 listed)
- Prior enrollment in a clinical trial
- Currently pregnant
- Currently incarcerated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyAttitudes and Randomized Trial Questionnaire (ARTQ), Hospital Anxiety and Depression Scale, Perception Survey | Other | Study Population |
Primary outcome
Willingness to Participate in Clinical Trials
Time frame: 6 months
Bivariate outcome derived from ARTQ survey
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 10 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Linda Duska, MD, MPH principal investigator
University of Virginia
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 Cancer, Clinical Trials, run by University of Virginia at 1 site in United States.
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 2 inclusion and 3 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 10 Oct 2018. 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 United States. 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?
Willingness to Participate in Clinical Trials (time frame: 6 months). 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 10 Oct 2018.