CancerPhase 3NCT02083770

Clinical Trials Education Program for Hispanic Americans

A Phase 3 study testing Cancer Clinical Trials Education Program in people with Cancer, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Hispanic Americans are underrepresented in cancer clinical trials. The purpose of this study is to develop and test programs designed to reduce barriers and increase facilitators associated with cancer clinical trials participation for Hispanic Americans. Read more about this study

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Cancer
What is being tested?: Cancer Clinical Trials Education Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,034 participants
Where: 1 siteUnited States
Study dates: Mar 2010to Aug 2018
Phase: Phase 3
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 21 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Self-identified as Hispanic American
At least 21 years of age
Sufficiently literate to comprehend written and spoken testing materials in English or Spanish
Living in southern California
Mentally competent to complete the informed consenting process

Who cannot join

Trial locations and contacts

1 site in 1 country.

United States1 site

UC San Diego Moores Cancer Center
La Jolla, California, 92093-0850

Other trials in United States

About this study

Official title: Randomized Controlled Clinical Trials Education Program for Hispanic Americans

Read the detailed description

Hispanic Americans are underrepresented in cancer clinical trials. The purpose of this study is to develop and test education programs designed to reduce barriers and Increase facilitators associated with cancer clinical trials participation for Hispanic Americans. Focus groups were conducted with Hispanic American men and women to obtain culturally-linked attitudes related to clinical trials participation. This information was used to create a prototypic educational program anticipated to increase participation in clinical trials. It was then vetted and honed via additional focus groups.

Simultaneously, a validation study was conducted with Hispanic Americans for a packet of psychosocial instruments that could be used for a subsequent randomized controlled trial to evaluate the impact of the clinical trials education program.

The finalized clinical trials education program was tested via a randomized controlled trial. Participants assigned to the experimental group received the clinical trials education program, while participants in the control arm were administered a comparable, but non-relevant education program. Recruitment to this study has been completed.

Conditions: Cancer
Being tested: Cancer Clinical Trials Education Program
Keywords: Hispanics, Patient Participation, Refusal to Participate, Education, Clinical Trials
Medical subject headings: Neoplasms, Patient Participation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cancer Clinical Trials Education ProgramBehavioural
Hispanic Americans are underrepresented in cancer clinical trials. The purpose of this study is to develop and test programs designed to reduce barriers and increase facilitators associated with cancer clinical trials participation for Hispanic Americans.

Study groups in NCT02083770
Study group	Role	What they receive
Cancer Clinical Trials Education Program	Experimental	Cancer Clinical Trials Education Program is offered to English- and Spanish-speaking Hispanics in the experimental arm. This program was designed to promote increased clinical trials literacy among Hispanic Americans. Increased clinical trials knowledge and a better understanding of clinical trials is anticipated to create more positive attitudes, and perceptions about clinical trials among Hispanic Americans. Receives: Behavioral: Cancer Clinical Trials Education Program
Neighborhood Watch Education Program	Placebo comparator	The Neighborhood Watch Program created by the Bureau of Justice Assistance and the National Crime Prevention Council was selected for inclusion in the control arm of this study. It provided participants with a program of equivalent length and format, as well as an equivalent focus on improving the well-being of Hispanic Americans. It also provided an opportunity to evaluate the impact of the Neighborhood Watch Program. Receives: Behavioral: Cancer Clinical Trials Education Program

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to First Follow-up
To assess the impact of the intervention arm on participants' knowledge, attitudes, and perceptions related to clinical trials, they were asked to complete the same surveys given at baseline during post-intervention immediately after intervention.
Measured: Change from baseline to first follow-up (immediately after receiving intervention)
Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to Second Follow-up
At the three-month follow-up, participants were mailed the final packet of survey instruments to complete and return in a stamped, self-addressed envelope.
Measured: Change from baseline to second follow-up (three months after receiving intervention)

Secondary outcomes (1)

Willingness to Participate in Research
Two weeks after receiving the intervention, participants were mailed an invitation to participate in a different research study by a researcher not previously known to them, to assess whether the intervention influenced behavior related to clinical trials invitations.
Measured: Two weeks after receiving intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Aug 2018

First posted11 Mar 2014 (estimated)
Study startMar 2010
Primary completionAug 2018
Study completionAug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CancerStudies 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: Interventional
Phase: Phase 3
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,034 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02083770
Sponsor's protocol ID: CCT2525
Other IDs: NCI R25CA 130869
Status last verified: Mar 2020
First submitted: 4 Mar 2014
Last updated: 4 Mar 2020
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Merz EL, Malcarne VL, Roesch SC, Riley N, Sadler GR. A multigroup confirmatory factor analysis of the Patient Health Questionnaire-9 among English- and Spanish-speaking Latinas. Cultur Divers Ethnic Minor Psychol. 2011 Jul;17(3):309-316. doi: 10.1037/a0023883.
PubMed 21787063

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Clinical Trials Education Program for Hispanic Americans
ClinicalTrials.gov ID: NCT02083770
Acronym / sponsor ID: CCT2525
Conditions: Cancer
Keywords: Hispanics, Patient Participation, Refusal to Participate, Education, Clinical Trials
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,034 participants (actual)
Lead sponsor: University of California, San DiegoUniversity, hospital or other
Collaborators: San Diego State University
Study start: Mar 2010 (actual)
Primary completion: Aug 2018 (actual)
Study completion: Aug 2018 (actual)
First posted: 11 Mar 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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Cancer Clinical Trials Education Program	Experimental	Behavioral: Cancer Clinical Trials Education ProgramCancer Clinical Trials Education Program is offered to English- and Spanish-speaking Hispanics in the experimental arm. This program was designed to promote increased clinical trials literacy among Hispanic Americans. Increased clinical trials knowledge and a better understanding of clinical trials is anticipated to create more positive attitudes, and perceptions about clinical trials among Hispanic Americans.
Neighborhood Watch Education Program	Placebo comparator	Behavioral: Cancer Clinical Trials Education ProgramThe Neighborhood Watch Program created by the Bureau of Justice Assistance and the National Crime Prevention Council was selected for inclusion in the control arm of this study. It provided participants with a program of equivalent length and format, as well as an equivalent focus on improving the well-being of Hispanic Americans. It also provided an opportunity to evaluate the impact of the Neighborhood Watch Program.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Self-identified as Hispanic American
At least 21 years of age
Sufficiently literate to comprehend written and spoken testing materials in English or Spanish
Living in southern California
Mentally competent to complete the informed consenting process

Key exclusion criteria (1 listed)

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
Cancer Clinical Trials Education ProgramHispanic Americans are underrepresented in cancer clinical trials. The purpose of this study is to develop and test programs designed to reduce barriers and increase facilitators associated with cancer clinical trials participation for Hispanic Americans.	Behavioural	Cancer Clinical Trials Education Program, Neighborhood Watch Education Program

Primary outcome

Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to First Follow-up
Time frame: Change from baseline to first follow-up (immediately after receiving intervention)
To assess the impact of the intervention arm on participants' knowledge, attitudes, and perceptions related to clinical trials, they were asked to complete the same surveys given at baseline during post-intervention immediately after intervention.
Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to Second Follow-up
Time frame: Change from baseline to second follow-up (three months after receiving intervention)
At the three-month follow-up, participants were mailed the final packet of survey instruments to complete and return in a stamped, self-addressed envelope.

1 secondary outcome

Willingness to Participate in Research
Time frame: Two weeks after receiving intervention

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 4 Mar 2020.
Background: PubMed 21787063Merz EL, Malcarne VL, Roesch SC, Riley N, Sadler GR. A multigroup confirmatory factor analysis of the Patient Health Questionnaire-9 among English- and Spanish-speaking Latinas. Cultur Divers Ethnic Minor Psychol. 2011 Jul;17(3):309-316. doi: 10.1037/a0023883.
Individual participant dataSharing planned: No

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Recurrent Respiratory Papillomatosis (RRP), Juvenile-onset Recurrent Respiratory Papillomatosis
RecruitingPhase 2
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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.

Georgia R Sadler, PhD principal investigator

UC San Diego Moores Cancer Center

Vanessa L Malcarne, PhD principal investigator

San Diego State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cancer Clinical Trials Education Program in people with Cancer, run by University of California, San Diego 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 5 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 4 Mar 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to First Follow-up (time frame: Change from baseline to first follow-up (immediately after receiving intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02083770, which also lists 1 linked publication.

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 4 Mar 2020.