Adult ALLNCT06386861
Validating the Spanish "Attitudes Toward Genomics and Precision Medicine" (AGPM).
A study testing Attitudes Toward Genomics and Precision Medicine (English) and Attitudes Toward Genomics and Precision Medicine (Spanish) in people with Adult ALL, run by Boston College at 1 site in United States.
Trial summary
The investigators aim to evaluate English and Spanish versions of the "Attitudes toward genomics and precision medicine" instrument (AGPM). This study will help validating a Spanish version of the AGPM among people identifying as Hispanic, Latino, or Latina. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adult ALL
- What is being tested?
- Attitudes Toward Genomics and Precision Medicine (English) and Attitudes Toward Genomics and Precision Medicine (Spanish)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 851 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult (18+ yrs.)
- identifying as Hispanic, Latino, or Latina
- able to provide opt-in electronic informed consent
Who cannot join
- under age 18 yrs.
- not identifying as Hispanic, Latino, or Latina
- not able to provide opt-in electronic informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing Culturally-Tailored Interventions to Overcome Genomic Health Disparities in Communities of Color
The investigators aim to evaluate English and Spanish versions of the "Attitudes toward genomics and precision medicine" instrument (AGPM). This study will help validating a Spanish version of the AGPM among people identifying as Hispanic, Latino, or Latina. Having a valid instrument is important for developing tailored interventions to decrease disparities in genomic healthcare for this population.
Read the detailed description
The investigators will recruit 1,000 individuals (500 English-speaking and 500 Spanish-speaking) to complete the AGPM and previously validated instruments assessing health literacy and numeracy. Results will establish the psychometric properties of the Spanish version of the AGPM.
- Conditions
- Adult ALL
- Being tested
- Attitudes Toward Genomics and Precision Medicine (English), Attitudes Toward Genomics and Precision Medicine (Spanish)
- Keywords
- genomics, precision medicine, attitudes and beliefs, health literacy, health numeracy
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attitudes Toward Genomics and Precision Medicine (English)Other
completing the English version of the AGPM and validated health literacy and numeracy instruments
Attitudes Toward Genomics and Precision Medicine (Spanish)Other
completing the Spanish version of the AGPM and validated health literacy and numeracy instruments
| Study group | Role | What they receive |
|---|---|---|
| AGPM for English Speakers | Other | Participants identifying as Hispanic, Latino, or Latina whose primary language is English Receives: Other: Attitudes Toward Genomics and Precision Medicine (English) |
| AGPM for Spanish Speakers | Other | Participants identifying as Hispanic, Latino, or Latina whose primary language is Spanish Receives: Other: Attitudes Toward Genomics and Precision Medicine (Spanish) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric properties
Establish the psychometric properties of the translated AGPM
Measured: up to two weeks
Secondary outcomes (1)
Health literacy/numeracy
Establish correlations between health literacy/numeracy and AGPM scores
Measured: up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start14 Apr 2024
- Primary completion15 Apr 2024
- Study completion31 Dec 2025 (estimated)
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 Adult ALLStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 500 English-speaking individuals identifying as Hispanic, Latino, or Latina 500 Spanish-speaking individuals identifying as Hispanic, Latino, or Latina
- Masking
- None (open label)
- Enrolment
- 851 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew A Dwyer, PhD, Principal investigator, Boston College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386861
- Sponsor's protocol ID
- 24.210.01e
- Status last verified
- Feb 2025
- First submitted
- 22 Apr 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with the developers of the AGPM
Publications
DuBois JM, Mozersky J, Antes A, English T, Parsons MV, Baldwin K. Attitudes toward genomics and precision medicine. J Clin Transl Sci. 2021 Apr 8;5(1):e120. doi: 10.1017/cts.2021.774. eCollection 2021.
PubMed 34267947
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Culturally-Tailored Interventions to Overcome Genomic Health Disparities in Communities of Color
- ClinicalTrials.gov ID
- NCT06386861
- Acronym / sponsor ID
- 24.210.01e
- Conditions
- Adult ALL
- Keywords
- genomics, precision medicine, attitudes and beliefs, health literacy, health numeracy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 851 participants (actual)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Study start
- 14 Apr 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Apr 2024 (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 investigators aim to evaluate English and Spanish versions of the "Attitudes toward genomics and precision medicine" instrument (AGPM). This study will help validating a Spanish version of the AGPM among people identifying as Hispanic, Latino, or Latina. Having a valid instrument is important for developing tailored interventions to decrease disparities in genomic healthcare for this population.
Detailed description
The investigators will recruit 1,000 individuals (500 English-speaking and 500 Spanish-speaking) to complete the AGPM and previously validated instruments assessing health literacy and numeracy. Results will establish the psychometric properties of the Spanish version of the AGPM.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 500 English-speaking individuals identifying as Hispanic, Latino, or Latina 500 Spanish-speaking individuals identifying as Hispanic, Latino, or Latina
| Arm | Type | Receives |
|---|---|---|
| AGPM for English Speakers | Other | Other: Attitudes Toward Genomics and Precision Medicine (English)Participants identifying as Hispanic, Latino, or Latina whose primary language is English |
| AGPM for Spanish Speakers | Other | Other: Attitudes Toward Genomics and Precision Medicine (Spanish)Participants identifying as Hispanic, Latino, or Latina whose primary language is Spanish |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult (18+ yrs.)
- identifying as Hispanic, Latino, or Latina
- able to provide opt-in electronic informed consent
Key exclusion criteria (3 listed)
- under age 18 yrs.
- not identifying as Hispanic, Latino, or Latina
- not able to provide opt-in electronic informed consent
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 |
|---|---|---|
| Attitudes Toward Genomics and Precision Medicine (English)completing the English version of the AGPM and validated health literacy and numeracy instruments | Other | AGPM for English Speakers |
| Attitudes Toward Genomics and Precision Medicine (Spanish)completing the Spanish version of the AGPM and validated health literacy and numeracy instruments | Other | AGPM for Spanish Speakers |
Primary outcome
Psychometric properties
Time frame: up to two weeks
Establish the psychometric properties of the translated AGPM
1 secondary outcome
Health literacy/numeracy
Time frame: up to two weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Background: PubMed 34267947DuBois JM, Mozersky J, Antes A, English T, Parsons MV, Baldwin K. Attitudes toward genomics and precision medicine. J Clin Transl Sci. 2021 Apr 8;5(1):e120. doi: 10.1017/cts.2021.774. eCollection 2021.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with the developers of the AGPM
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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.
Andrew A Dwyer, PhD principal investigator
Boston College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attitudes Toward Genomics and Precision Medicine (English) and Attitudes Toward Genomics and Precision Medicine (Spanish) in people with Adult ALL, run by Boston College 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 3 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: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Psychometric properties (time frame: up to two weeks). 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 NCT06386861, 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 5 Feb 2025.