Clinical TrialNCT02600533
Increasing Minority Participation in Clinical Trials
A study testing Video viewing group in people with Clinical Trial, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This study will measure the effects of an office-based, clinical trial education video on clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no previous history of clinical trial participation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Trial
- What is being tested?
- Video viewing group
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 28 Jun 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be patients of Vanderbilt-Ingram Cancer Center (VICC) with a diagnosis of cancer Participants will have no previous history of clinical trial research participation
Who cannot join
- Previous history of clinical trial research participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Ingram Cancer Center, Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Increasing Minority Group Participation in Clinical Trials a Randomized Controlled Study of an Office-based Educational Video
This study will measure the effects of an office-based, clinical trial education video on clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no previous history of clinical trial participation. This study will also determine the feasibility of implementing an office-based video educational program.
Read the detailed description
Clinical trials are essential to scientific discovery and are critical to translating research in to practice. Despite their significance, clinical trial participation rates remain low, especially among underrepresented minority groups. Several barriers exist to minority group participation in clinical trial, one of which lack of awareness about clinical trials. Video educational programs show promise as an effective strategy to increase knowledge and clinical trial participation. The specific aims are as follows:
- Measure the effects of an office-based, clinical trial education video on clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no previous history of clinical trial participation.
- Determine the feasibility of implementing an office-based video educational program.
- Conditions
- Clinical Trial
- Being tested
- Video viewing group
- Keywords
- minority group recruitment, stages of implementation, clinical trials education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video viewing groupProcedure or surgery
Also called video group
First, participants will complete a brief electronic survey measuring their opinions on clinical trials. Next, participants in the video viewing group will watch the 10-minute DVD video on tablet devices using headphones in the clinic. Participants in this groups will be informed that a team member will call him/her in approximately 1 week to ask him/her the (same) questions about clinical research.
| Study group | Role | What they receive |
|---|---|---|
| Standard care/control group | No intervention | First, participants will complete a brief electronic survey measuring their opinions on clinical trials. Next, participants in the standard of care group will be provided standard educational resources (booklet and DVD), with no additional instructions. Participants in this groups will be informed that a team member will call him/her in approximately 1 week to ask him/her the (same) questions about clinical research. |
| Video viewing group | Experimental | First, participants will complete a brief electronic survey measuring their opinions on clinical trials. Next, participants in the video viewing group will watch the 10-minute DVD video on tablet devices using headphones in the clinic. Participants in this groups will be informed that a team member will call him/her in approximately 1 week to ask him/her the (same) questions about clinical research. Receives: Procedure: Video viewing group |
What is being measured
The primary outcome is the main question the study is designed to answer.
study feasibility
The stages of implementation completion (SIC) measure will be used as an internal tool utilized by the study team to track time to achievement of key implementation milestones. An 8-stage implementation plan to measure feasibility of the office-based educational program will be executed across 3 phases. Three scores will be derived from the SIC measure. The first score is the number of stages completed. The second score is the time spent at each stage. The third score is the proportion of activities completed at each stage. Implementation of the SIC model poses no additional burden on study participants.
Measured: 12 months
Secondary outcomes (3)
Clinical trial participation
Information on clinical trial participation will be collected by a team member by reviewing the participants' health record and by contacting the VICC clinical trial team.
Measured: 12 months
Clinical trial knowledge survey
This survey consist of 22-items assessing a participants views on clinical trials on 5 domains (positive beliefs, safety, information needs, negative expectations, and patient involvement).
Measured: 7-10 days
Likelihood to participate survey
This survey consist of 5-items assessing reasons for not participating in research, views about sources of research, views about sharing of research data, trust, and willingness to advise research teams.
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startDec 2014
- Primary completion28 Jun 2017
- Study completion28 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical TrialStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Meharry-Vanderbilt Alliance
- Responsible party
- Principal investigator, Consuelo H Wilkins, Vanderbilt University Medical Center
- Investigators
- Consuelo H. Wilkins, MD, Principal investigator, Meharry-Vanderbilt Alliance, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600533
- Sponsor's protocol ID
- 14117
- Other IDs
- P30CA068485
- Status last verified
- Sep 2017
- First submitted
- 5 Nov 2015
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Minority Group Participation in Clinical Trials a Randomized Controlled Study of an Office-based Educational Video
- ClinicalTrials.gov ID
- NCT02600533
- Acronym / sponsor ID
- 14117
- Conditions
- Clinical Trial
- Keywords
- minority group recruitment, stages of implementation, clinical trials education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Meharry-Vanderbilt Alliance
- Study start
- Dec 2014 (actual)
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- 28 Jun 2017 (actual)
- First posted
- 9 Nov 2015 (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.
This study will measure the effects of an office-based, clinical trial education video on clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no previous history of clinical trial participation. This study will also determine the feasibility of implementing an office-based video educational program.
Detailed description
Clinical trials are essential to scientific discovery and are critical to translating research in to practice. Despite their significance, clinical trial participation rates remain low, especially among underrepresented minority groups. Several barriers exist to minority group participation in clinical trial, one of which lack of awareness about clinical trials. Video educational programs show promise as an effective strategy to increase knowledge and clinical trial participation. The specific aims are as follows:
- Measure the effects of an office-based, clinical trial education video on clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no previous history of clinical trial participation.
- Determine the feasibility of implementing an office-based video educational program.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care/control group | No intervention | –First, participants will complete a brief electronic survey measuring their opinions on clinical trials. Next, participants in the standard of care group will be provided standard educational resources (booklet and DVD), with no additional instructions. Participants in this groups will be informed that a team member will call him/her in approximately 1 week to ask him/her the (same) questions about clinical research. |
| Video viewing group | Experimental | Procedure: Video viewing groupFirst, participants will complete a brief electronic survey measuring their opinions on clinical trials. Next, participants in the video viewing group will watch the 10-minute DVD video on tablet devices using headphones in the clinic. Participants in this groups will be informed that a team member will call him/her in approximately 1 week to ask him/her the (same) questions about clinical research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will be patients of Vanderbilt-Ingram Cancer Center (VICC) with a diagnosis of cancer Participants will have no previous history of clinical trial research participation
Key exclusion criteria (1 listed)
- Previous history of clinical trial research participation
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 |
|---|---|---|
| Video viewing groupAlso: video groupFirst, participants will complete a brief electronic survey measuring their opinions on clinical trials. Next, participants in the video viewing group will watch the 10-minute DVD video on tablet devices using headphones in the clinic. Participants in this groups will be informed that a team member will call him/her in approximately 1 week to ask him/her the (same) questions about clinical research. | Procedure or surgery | Video viewing group |
Primary outcome
study feasibility
Time frame: 12 months
The stages of implementation completion (SIC) measure will be used as an internal tool utilized by the study team to track time to achievement of key implementation milestones. An 8-stage implementation plan to measure feasibility of the office-based educational program will be executed across 3 phases. Three scores will be derived from the SIC measure. The first score is the number of stages completed. The second score is the time spent at each stage. The third score is the proportion of activities completed at each stage. Implementation of the SIC model poses no additional burden on study participants.
3 secondary outcomes
Clinical trial participation
Time frame: 12 months
Clinical trial knowledge survey
Time frame: 7-10 days
Likelihood to participate survey
Time frame: 7-10 days
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 11 Sep 2017.
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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.
Consuelo H. Wilkins, MD principal investigator
Meharry-Vanderbilt Alliance, Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video viewing group in people with Clinical Trial, run by Vanderbilt University Medical Center 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 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 11 Sep 2017. 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?
study feasibility (time frame: 12 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 11 Sep 2017.