Cancer PreventionNCT04638010
Increasing Breast, Cervical, and Colorectal Cancer Screening and HPV Vaccination Among Underserved Texans
A study of Cancer Prevention, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This study involves a partnership between UTHealth School of Public Health and the Texas 2-1-1 service, which is a helpline connecting low-income and minority callers with a number of needed services. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,554 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2011to 6 Dec 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- callers to 2-1-1
- consents to participate,
- English or Spanish speaking
- not in a crisis (e.g., disaster-related 2-1-1 call or personal crisis)
Who cannot join
- not English or Spanish speaking
- in crisis (e.g., disaster-related call or personal crisis)
- calling on behalf of another client and not for self
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Increasing Breast, Cervical, and Colorectal Cancer Screening and HPV Vaccination Among Underserved Texans: A Collaboration With the United Way's 2-1-1 Program
This study involves a partnership between UTHealth School of Public Health and the Texas 2-1-1 service, which is a helpline connecting low-income and minority callers with a number of needed services. The purpose of this study is to evaluate the effectiveness of a prevention program in which a phone navigator intervention designed to connect 2-1-1 helpline callers to evidence-based screening and prevention services including mammography, Pap test screening, colorectal cancer screening, and HPV vaccination.
- Conditions
- Cancer Prevention
- Being tested
- Cancer control navigation (CNN), General referral (usual care)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer control navigation (CNN)Behavioural
Cancer Control Navigators (CNNs) housed at 2-1-1 call centers aid callers. CNNs receive electronic summary profiles of participants assigned to navigation. Navigators call the participant, build a collaborative relationship with them, identify their needs, work with them to identify barriers to services and coordinate solutions, and provide logistic (e.g., making appointments) and emotional support. Navigation services are provided by telephone only.
General referral (usual care)Behavioural
Information Specialists at the 2-1-1 call center provide cancer control referrals specific to participant's screening or prevention needs.
| Study group | Role | What they receive |
|---|---|---|
| Cancer control navigation (CNN) plus General referral (usual care) | Experimental | Information Specialists at the 2-1-1 call center provide cancer control referrals specific to participant's screening or prevention needs.
Additionally, Cancer Control Navigators (CNNs) housed at 2-1-1 call centers aid callers. CNNs receive electronic summary profiles of participants assigned to navigation. Navigators call the participant, build a collaborative relationship with them, identify their needs, work with them to identify barriers to services and coordinate solutions, and provide logistic (e.g., making appointments) and emotional support. Navigation services are provided by telephone only. Receives: Behavioral: Cancer control navigation (CNN); Behavioral: General referral (usual care) |
| General referral (usual care) | Active comparator | Information Specialists at the 2-1-1 call center provide cancer control referrals specific to participant's screening or prevention needs. Receives: Behavioral: General referral (usual care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who complete needed cancer screening and prevention services
Cancer screening and prevention services include mammogram, Pap test, HPV vaccine, and/or colorectal cancer screening.
Measured: one month after referral
Number of participants who complete needed cancer screening and prevention services
Cancer screening and prevention services include mammogram, Pap test, HPV vaccine, and/or colorectal cancer screening.
Measured: three months after referral
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start16 Feb 2011
- Primary completion6 Dec 2013
- Study completion6 Dec 2013
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 Cancer PreventionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,554 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Responsible party
- Principal investigator, Maria E Fernandez, The University of Texas Health Science Center, Houston
- Investigators
- Maria E Fernandez, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638010
- Sponsor's protocol ID
- HSC-SPH-10-0241
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernandez ME, Savas LS, Atkinson JS, Ricks KB, Ibekwe LN, Jackson I, Castle PE, Jobe D, Vernon SW. Evaluation of a 2-1-1 Telephone Navigation Program to Increase Cancer Control Behaviors: Results From a Randomized Controlled Trial. Am J Health Promot. 2022 Sep;36(7):1083-1093. doi: 10.1177/08901171211041276. Epub 2022 May 5.
PubMed 35514063
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Breast, Cervical, and Colorectal Cancer Screening and HPV Vaccination Among Underserved Texans: A Collaboration With the United Way's 2-1-1 Program
- ClinicalTrials.gov ID
- NCT04638010
- Acronym / sponsor ID
- HSC-SPH-10-0241
- Conditions
- Cancer Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,554 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Study start
- 16 Feb 2011 (actual)
- Primary completion
- 6 Dec 2013 (actual)
- Study completion
- 6 Dec 2013 (actual)
- First posted
- 20 Nov 2020 (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.
This study involves a partnership between UTHealth School of Public Health and the Texas 2-1-1 service, which is a helpline connecting low-income and minority callers with a number of needed services. The purpose of this study is to evaluate the effectiveness of a prevention program in which a phone navigator intervention designed to connect 2-1-1 helpline callers to evidence-based screening and prevention services including mammography, Pap test screening, colorectal cancer screening, and HPV vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer control navigation (CNN) plus General referral (usual care) | Experimental | Behavioral: Cancer control navigation (CNN), Behavioral: General referral (usual care)Information Specialists at the 2-1-1 call center provide cancer control referrals specific to participant's screening or prevention needs. Additionally, Cancer Control Navigators (CNNs) housed at 2-1-1 call centers aid callers. CNNs receive electronic summary profiles of participants assigned to navigation. Navigators call the participant, build a collaborative relationship with them, identify their needs, work with them to identify barriers to services and coordinate solutions, and provide logistic (e.g., making appointments) and emotional support. Navigation services are provided by telephone only. |
| General referral (usual care) | Active comparator | Behavioral: General referral (usual care)Information Specialists at the 2-1-1 call center provide cancer control referrals specific to participant's screening or prevention needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- callers to 2-1-1
- consents to participate,
- English or Spanish speaking
- not in a crisis (e.g., disaster-related 2-1-1 call or personal crisis)
Key exclusion criteria (3 listed)
- not English or Spanish speaking
- in crisis (e.g., disaster-related call or personal crisis)
- calling on behalf of another client and not for self
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 control navigation (CNN)Cancer Control Navigators (CNNs) housed at 2-1-1 call centers aid callers. CNNs receive electronic summary profiles of participants assigned to navigation. Navigators call the participant, build a collaborative relationship with them, identify their needs, work with them to identify barriers to services and coordinate solutions, and provide logistic (e.g., making appointments) and emotional support. Navigation services are provided by telephone only. | Behavioural | Cancer control navigation (CNN) plus General referral (usual care) |
| General referral (usual care)Information Specialists at the 2-1-1 call center provide cancer control referrals specific to participant's screening or prevention needs. | Behavioural | Cancer control navigation (CNN) plus General referral (usual care), General referral (usual care) |
Primary outcome
Number of participants who complete needed cancer screening and prevention services
Time frame: one month after referral
Cancer screening and prevention services include mammogram, Pap test, HPV vaccine, and/or colorectal cancer screening.
Number of participants who complete needed cancer screening and prevention services
Time frame: three months after referral
Cancer screening and prevention services include mammogram, Pap test, HPV vaccine, and/or colorectal cancer screening.
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 20 Nov 2020.
- Derived from this study: PubMed 35514063Fernandez ME, Savas LS, Atkinson JS, Ricks KB, Ibekwe LN, Jackson I, Castle PE, Jobe D, Vernon SW. Evaluation of a 2-1-1 Telephone Navigation Program to Increase Cancer Control Behaviors: Results From a Randomized Controlled Trial. Am J Health Promot. 2022 Sep;36(7):1083-1093. doi: 10.1177/08901171211041276. Epub 2022 May 5.
- 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.
Maria E Fernandez, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cancer Prevention, run by The University of Texas Health Science Center, Houston 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 4 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 20 Nov 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. 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?
Number of participants who complete needed cancer screening and prevention services (time frame: one month after referral). 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 NCT04638010, 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 20 Nov 2020.