Breast CancerNCT03557801
Promotora Navigator - Culturally Appropriate Patient Navigator
A study testing Mammography with Community Health Worker (individual) and Mammography with Community Health Worker (group) in people with Breast Cancer and Screening Mammography, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Although there has been interval improvement in reducing disparity in mammography utilization in medically underserved communities since the 1990s, significant disparities persist and should be addressed. Read more about this study
- Who is it for?
- Ages 40 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Screening Mammography, Community Health Worker
- What is being tested?
- Mammography with Community Health Worker (individual) and Mammography with Community Health Worker (group)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2018to 15 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women
- Identifying as Hispanic ethnicity
- Age 40-64
- Tennessee resident
Who cannot join
- Personal history of breast cancer
- Current breast symptoms (palpable mass)
Trial locations and contacts
1 site in 1 country.
United States1 site
Matthew Walker Comprehensive Health Center
Nashville, Tennessee, 37208
About this study
Official title: Assessing the Impact of a Community Health Worker on Hispanic Women's Reported Measures of Processes of Care in the Screening Mammography Setting
Although there has been interval improvement in reducing disparity in mammography utilization in medically underserved communities since the 1990s, significant disparities persist and should be addressed. In the 40-65 year old age range, there is significant disparity in screening mammography utilization in Hispanic women compared to their white counterparts.
Culturally adapted patient-targeted healthcare interventions can help reduce ethnic inequalities in access to cancer screening programs. Promotoras, culturally appropriate patient navigators for the Hispanic community, have been shown to increase screening mammography rates in the Hispanic/Latino population.
However, there is little research exploring the interaction between these lay community health workers and community members. This proposal aims to assess this interaction by measuring the impact of a Promotora working with community members in either a group setting or individual setting. Understanding this interaction can lead to more effectively designed future community interventions. Primary outcomes in this study will include women's reported measures of interpersonal processes of care (communication and interpersonal style) during screening mammography care, trust in the healthcare system, and satisfaction with cancer screening care when compared to those receiving standard of care.
- Being tested
- Mammography with Community Health Worker (individual), Mammography with Community Health Worker (group), Standard of Care Mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mammography with Community Health Worker (individual)Behavioural
Immediately following consent and completion of the baseline assessment, alone with the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.
Mammography with Community Health Worker (group)Behavioural
Immediately following consent and completion of the baseline assessment, women in the intervention arm will participate in a 20-30 minute group educational session from the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.
Standard of Care MammographyOther
Immediately following consent and completion of the baseline assessment, women in the control arm will receive standard of care well woman screening. The control arm will receive screening results per standard protocol.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Mammography | Active comparator | Immediately following consent and completion of the baseline assessment, women in the control arm will receive standard of care well woman screening. The control arm will receive screening results per standard of care protocol. Receives: Other: Standard of Care Mammography |
| Mammography with Community Health Worker (individual) | Experimental | Immediately following consent and completion of the baseline assessment, women in the intervention arm 1 will participate in a 20-30 minute educational session alone with the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary. Receives: Behavioral: Mammography with Community Health Worker (individual) |
| Mammography with Community Health Worker (group) | Experimental | Immediately following consent and completion of the baseline assessment, women in the intervention arm will participate in a 20-30 minute group educational session from the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary. Receives: Behavioral: Mammography with Community Health Worker (group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Measures From Interpersonal Processes of Care Survey
Selected scales (communication and interpersonal style) of the Interpersonal Processes of Care Survey will be the primary outcome. A total of 18 (corrected from orginal submission) questions will be administered. The questions are scored on a scale from 1-5 with higher scores indicating higher frequencies of the construct. The compiled scores will range from 5-90. Scales with negative associations (discrimination, hurried communication) will be reversed. Thus, higher scores for all items will indicate a more positive experience.
Measured: Approximately 2 weeks after consent/screening mammogram.
Secondary outcomes (2)
Patient Reported Measures From the Distrust in the Healthcare System Scale. Reported at Baseline and Post Intervention. Also Reported as the Change Between Baseline and Intervention.
Distrust will be measured with the Revised Healthcare System Distrust Scale. This 9 question scale is divided into two subscales: competence and values. The questions are scored on a scale from 1-5. The total score will range 5-45, with higher scores indicating higher levels of trust. Baseline distrust measured at time of initial consent/screening. Post-intervention distrust measured at time of post-survey which took place approximately 2 weeks after screening (varied as to when patient could be reached for survey). Difference in distrust is subtracts the baseline score from the post score.
Measured: Baseline, approximately 2 weeks after consent/screening mammogram.
Patient Reported Measures From the Satisfaction With Cancer Related Care Scale.
Satisfaction with care will be measured with the Patient Satisfaction with Cancer-Related Care (PSCC) Measure. This is an 18 question measure. The questions are scored on a scale from 1-5. The total score will range 5-90, higher scores indicate higher satisfaction with care.
Measured: Approximately 2 weeks after consent/screening mammogram.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start7 Jun 2018
- Primary completion15 Oct 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucy Spalluto, Vanderbilt University Medical Center
- Investigators
- Lucy Spalluto, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557801
- Sponsor's protocol ID
- 180276
- Status last verified
- Jul 2019
- First submitted
- 4 Jun 2018
- Last updated
- 14 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of a Community Health Worker on Hispanic Women's Reported Measures of Processes of Care in the Screening Mammography Setting
- ClinicalTrials.gov ID
- NCT03557801
- Acronym / sponsor ID
- 180276
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Posted 31 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although there has been interval improvement in reducing disparity in mammography utilization in medically underserved communities since the 1990s, significant disparities persist and should be addressed. In the 40-65 year old age range, there is significant disparity in screening mammography utilization in Hispanic women compared to their white counterparts.
Culturally adapted patient-targeted healthcare interventions can help reduce ethnic inequalities in access to cancer screening programs. Promotoras, culturally appropriate patient navigators for the Hispanic community, have been shown to increase screening mammography rates in the Hispanic/Latino population.
However, there is little research exploring the interaction between these lay community health workers and community members. This proposal aims to assess this interaction by measuring the impact of a Promotora working with community members in either a group setting or individual setting. Understanding this interaction can lead to more effectively designed future community interventions. Primary outcomes in this study will include women's reported measures of interpersonal processes of care (communication and interpersonal style) during screening mammography care, trust in the healthcare system, and satisfaction with cancer screening care when compared to those receiving standard of care.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Mammography | Active comparator | Other: Standard of Care MammographyImmediately following consent and completion of the baseline assessment, women in the control arm will receive standard of care well woman screening. The control arm will receive screening results per standard of care protocol. |
| Mammography with Community Health Worker (individual) | Experimental | Behavioral: Mammography with Community Health Worker (individual)Immediately following consent and completion of the baseline assessment, women in the intervention arm 1 will participate in a 20-30 minute educational session alone with the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary. |
| Mammography with Community Health Worker (group) | Experimental | Behavioral: Mammography with Community Health Worker (group)Immediately following consent and completion of the baseline assessment, women in the intervention arm will participate in a 20-30 minute group educational session from the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women
- Identifying as Hispanic ethnicity
- Age 40-64
- Tennessee resident
Key exclusion criteria (2 listed)
- Personal history of breast cancer
- Current breast symptoms (palpable mass)
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 |
|---|---|---|
| Mammography with Community Health Worker (individual)Immediately following consent and completion of the baseline assessment, alone with the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary. | Behavioural | Mammography with Community Health Worker (individual) |
| Mammography with Community Health Worker (group)Immediately following consent and completion of the baseline assessment, women in the intervention arm will participate in a 20-30 minute group educational session from the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary. | Behavioural | Mammography with Community Health Worker (group) |
| Standard of Care MammographyImmediately following consent and completion of the baseline assessment, women in the control arm will receive standard of care well woman screening. The control arm will receive screening results per standard protocol. | Other | Standard of Care Mammography |
Primary outcome
Patient Reported Measures From Interpersonal Processes of Care Survey
Time frame: Approximately 2 weeks after consent/screening mammogram.
Selected scales (communication and interpersonal style) of the Interpersonal Processes of Care Survey will be the primary outcome. A total of 18 (corrected from orginal submission) questions will be administered. The questions are scored on a scale from 1-5 with higher scores indicating higher frequencies of the construct. The compiled scores will range from 5-90. Scales with negative associations (discrimination, hurried communication) will be reversed. Thus, higher scores for all items will indicate a more positive experience.
2 secondary outcomes
Patient Reported Measures From the Distrust in the Healthcare System Scale. Reported at Baseline and Post Intervention. Also Reported as the Change Between Baseline and Intervention.
Time frame: Baseline, approximately 2 weeks after consent/screening mammogram.
Patient Reported Measures From the Satisfaction With Cancer Related Care Scale.
Time frame: Approximately 2 weeks after consent/screening mammogram.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Lucy Spalluto, MD principal investigator
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 Mammography with Community Health Worker (individual) and Mammography with Community Health Worker (group) in people with Breast Cancer and Screening Mammography, 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 4 inclusion and 2 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 14 Aug 2019. 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?
Yes. Results are posted in the registry (first posted 31 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Reported Measures From Interpersonal Processes of Care Survey (time frame: Approximately 2 weeks after consent/screening mammogram.). 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 14 Aug 2019.