Breast Cancer in SituNCT03052907
Breast Screening & Patient Navigation (BSPAN2): Evaluating a De-Centralized Regional Delivery System for Rural Underserved
A study testing BSPAN in people with Breast Cancer in Situ, run by University of Texas Southwestern Medical Center.
Trial summary
The investigators will expand BSPan's reach and sustainability by systematizing how to enable counties to assume responsibility for one or two of the components while Moncrief/uTSW continues to provide centralized financial review and reimbursement as the Texas BCCS contractor. 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 in Situ
- What is being tested?
- BSPAN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,540 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Nov 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 40 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- adult females age 40-64,
- able to read, speak and comprehend English or Spanish,
- the capacity to comprehend study information, and
- ability to communicate with voice (to participate in interviews).
- involved in facilitation of mammography screening services in the counties served by the BSPAN program.
- Both women and men will be eligible to participate.
- No racial or ethnic group will be excluded from participation.
Who cannot join
- Patients who do not speak Spanish or English or have severely impaired hearing or speech or do not give informed consent will be excluded from participation (in interviews).
- individuals not involved in the facilitation of mammography screening services in one of the counties served by the BSPAN program will be excluded from participation.
About this study
The investigators will expand BSPan's reach and sustainability by systematizing how to enable counties to assume responsibility for one or two of the components while Moncrief/uTSW continues to provide centralized financial review and reimbursement as the Texas BCCS contractor. The investigators will prospectively identify which counties have the necessary program capacity, then test whether implementation of BSPan tailored to a county's capacity and local needs can lead to equivalent program success in an additional 12 rural counties. Findings will be used to develop a model by which BSPan benefits can be brought to rural communities across the country.
The investigators will use a readiness assessment criteria (RaC) to gauge county capacity and readiness for BSPan program implementation. The goal of our evaluation is to demonstrate whether a regional decentralized delivery (hub-and-spoke) model can be sustained and increase program reach to underserved rural women. The RaC tool serves two purposes: 1) to determine county capacity and 2) harness program data to facilitate communication during operations between a central BSPan hub and each county partner (spokes).
Read more
Our evaluation will analyze county training and implementation of BSPan program components, and comprehensive screening processes of the hub and spoke model. The investigators will use county site visits and selected interviews of participants and staff to gain insight into factors at the participant and county levels that facilitate adoption and implementation of comprehensive screening processes, in conjunction with key quantitative metrics and process outcomes.
The investigators will apply the Glasgow Re-aiM model to guide our evaluation of BSPan program component implementation in each county. Re-aiM specifies dimensions at the participant and organizational levels. Dimensions are defined as the intervention's: 1) Reach into the target population, 2) effectiveness in modifying risk, 3) adoption by target settings, 4) consistent implementation, and 5) Maintenance of its effects among participants and target settings. our mixed-methods approach will enable focus at both the individual and organizational levels and has been successfully used to assess other similar screening and health promotion programs.
Read the detailed description
Specific aims are to:
- Identify readiness assessment criteria (RAC) essential in determining a rural county's capacity to support comprehensive mammography and appropriate follow-up services. Through a mixed-method analysis, using qualitative and quantitative techniques, we will define essential factors in leadership, infrastructure and local resources across the five counties of the initial BSPAN network.
- Using the RAC (defined in Aim 1), we will determine which of the five BSPAN1 counties have capacity to manage and sustain the Outreach \& Health Promotion and Delivery \& Navigation components of the program (High Capacity), and which have the capacity to manage and sustain only the Outreach \& Health Promotion component (Medium Capacity). We will monitor the performance of two High Capacity and one Medium Capacity counties to increase program responsibility, adjust BSPAN support as needed, and calibrate the sensitivity of our RAC tool.
- Expand BSPAN to 12 new rural and underserved counties according to RAC score and evaluate each county's ability to implement program components and increase comprehensive mammography and appropriate follow-up. Using the RAC (defined in Aim 1), we will characterize the capacity in each of the 12 new counties to implement components of the BSPAN program (High, Medium, and Low Capacity). We will monitor process measures and outcomes in each county at regular intervals. Results of BSPAN2 will demonstrate a sustainable hub-and-spoke model of service delivery that capitalizes on local community strengths to care for their own residents. This expansion will enable 12 new county partners to increase screening access, improve time to diagnostic resolution, and facilitate timely referral to local treatment services, while maintaining services levels in the original five counties. BSPAN2 will also produce an assessment tool and internet-based patient tracking application that can be used to disseminate a hub-and-spoke model for delivery of mammography services to rural communities across the country.
- Conditions
- Breast Cancer in Situ
- Being tested
- BSPAN
- Medical subject headings
- Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BSPANBehavioural
- Identify readiness assessment criteria (RAC) essential in determining a rural county's capacity to support comprehensive mammography and appropriate follow-up services.
- Using the RAC, we will determine which of the five BSPAN1 counties have capacity to manage and sustain the Outreach \& Health Promotion and Delivery \& Navigation components of the program (High Capacity), and which have the capacity to manage and sustain only the Outreach \& Health Promotion component (Medium Capacity).
- Expand BSPAN to 12 new rural and underserved counties according to RAC score and evaluate each county's ability to implement program components and increase comprehensive mammography and appropriate follow-up.
| Study group | Role | What they receive |
|---|---|---|
| BSPAN Expansion | Other | We will expand BSPAN's reach and sustainability by systematizing how to enable counties to assume responsibility for one or two of the components while Moncrief/UTSW continues to provide centralized financial review and reimbursement as the Texas BCCS contractor. We will prospectively identify which counties have the necessary program capacity, then test whether implementation of BSPAN tailored to a county's capacity and local needs can lead to equivalent program success in an additional 12 rural counties (BSPAN2 total= 17 counties). Findings will be used to develop a model by which BSPAN benefits can be brought to rural communities across the country. Receives: Behavioral: BSPAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey items measuring delivery of comprehensive mammography services and appropriate follow-up for women in rural and underserved counties.
We will use NVivo 9.0 (QSR International, Melbourne AUS) to collate and analyze data from site visits notes, semi-structured interviews, and document analysis. NVivo, a well-respected qualitative data analysis software program, makes the analysis process transparent so that investigators can track their evolving analysis. Led by Drs. Lee and Inrig, the evaluation team and their staff will organize these codes into a codebook that relates data to behavioral and organizational theory. Regular meetings will enable the BSPAN evaluation team to test emergent themes and interpretation against the knowledge base of experts in clinical medicine (e.g. Argenbright), organizational behavior (Inrig, Lee), and screening behavior (Tiro). Cross-analysis of data from all sources will allow us to conduct an integrated analysis across BSPAN components to assess key steps and interface of mammography screening and appropriate follow-up.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study startNov 2012
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer in SituStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18,540 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Lee, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052907
- Sponsor's protocol ID
- SCCC-PS01112
- Status last verified
- Apr 2018
- First submitted
- 9 Feb 2017
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Screening & Patient Navigation (BSPAN2): Evaluating a De-Centralized Regional Delivery System for Rural Underserved
- ClinicalTrials.gov ID
- NCT03052907
- Acronym / sponsor ID
- SCCC-PS01112
- Conditions
- Breast Cancer in Situ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18,540 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 14 Feb 2017 (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 will expand BSPan's reach and sustainability by systematizing how to enable counties to assume responsibility for one or two of the components while Moncrief/uTSW continues to provide centralized financial review and reimbursement as the Texas BCCS contractor. The investigators will prospectively identify which counties have the necessary program capacity, then test whether implementation of BSPan tailored to a county's capacity and local needs can lead to equivalent program success in an additional 12 rural counties. Findings will be used to develop a model by which BSPan benefits can be brought to rural communities across the country.
The investigators will use a readiness assessment criteria (RaC) to gauge county capacity and readiness for BSPan program implementation. The goal of our evaluation is to demonstrate whether a regional decentralized delivery (hub-and-spoke) model can be sustained and increase program reach to underserved rural women. The RaC tool serves two purposes: 1) to determine county capacity and 2) harness program data to facilitate communication during operations between a central BSPan hub and each county partner (spokes).
Our evaluation will analyze county training and implementation of BSPan program components, and comprehensive screening processes of the hub and spoke model. The investigators will use county site visits and selected interviews of participants and staff to gain insight into factors at the participant and county levels that facilitate adoption and implementation of comprehensive screening processes, in conjunction with key quantitative metrics and process outcomes.
The investigators will apply the Glasgow Re-aiM model to guide our evaluation of BSPan program component implementation in each county. Re-aiM specifies dimensions at the participant and organizational levels. Dimensions are defined as the intervention's: 1) Reach into the target population, 2) effectiveness in modifying risk, 3) adoption by target settings, 4) consistent implementation, and 5) Maintenance of its effects among participants and target settings. our mixed-methods approach will enable focus at both the individual and organizational levels and has been successfully used to assess other similar screening and health promotion programs.
Detailed description
Specific aims are to:
- Identify readiness assessment criteria (RAC) essential in determining a rural county's capacity to support comprehensive mammography and appropriate follow-up services. Through a mixed-method analysis, using qualitative and quantitative techniques, we will define essential factors in leadership, infrastructure and local resources across the five counties of the initial BSPAN network.
- Using the RAC (defined in Aim 1), we will determine which of the five BSPAN1 counties have capacity to manage and sustain the Outreach \& Health Promotion and Delivery \& Navigation components of the program (High Capacity), and which have the capacity to manage and sustain only the Outreach \& Health Promotion component (Medium Capacity). We will monitor the performance of two High Capacity and one Medium Capacity counties to increase program responsibility, adjust BSPAN support as needed, and calibrate the sensitivity of our RAC tool.
- Expand BSPAN to 12 new rural and underserved counties according to RAC score and evaluate each county's ability to implement program components and increase comprehensive mammography and appropriate follow-up. Using the RAC (defined in Aim 1), we will characterize the capacity in each of the 12 new counties to implement components of the BSPAN program (High, Medium, and Low Capacity). We will monitor process measures and outcomes in each county at regular intervals. Results of BSPAN2 will demonstrate a sustainable hub-and-spoke model of service delivery that capitalizes on local community strengths to care for their own residents. This expansion will enable 12 new county partners to increase screening access, improve time to diagnostic resolution, and facilitate timely referral to local treatment services, while maintaining services levels in the original five counties. BSPAN2 will also produce an assessment tool and internet-based patient tracking application that can be used to disseminate a hub-and-spoke model for delivery of mammography services to rural communities across the country.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BSPAN Expansion | Other | Behavioral: BSPANWe will expand BSPAN's reach and sustainability by systematizing how to enable counties to assume responsibility for one or two of the components while Moncrief/UTSW continues to provide centralized financial review and reimbursement as the Texas BCCS contractor. We will prospectively identify which counties have the necessary program capacity, then test whether implementation of BSPAN tailored to a county's capacity and local needs can lead to equivalent program success in an additional 12 rural counties (BSPAN2 total= 17 counties). Findings will be used to develop a model by which BSPAN benefits can be brought to rural communities across the country. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- adult females age 40-64,
- able to read, speak and comprehend English or Spanish,
- the capacity to comprehend study information, and
- ability to communicate with voice (to participate in interviews).
- involved in facilitation of mammography screening services in the counties served by the BSPAN program.
Key exclusion criteria (2 listed)
- Patients who do not speak Spanish or English or have severely impaired hearing or speech or do not give informed consent will be excluded from participation (in interviews).
- individuals not involved in the facilitation of mammography screening services in one of the counties served by the BSPAN program will be excluded from 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 |
|---|---|---|
| BSPAN1. Identify readiness assessment criteria (RAC) essential in determining a rural county's capacity to support comprehensive mammography and appropriate follow-up services. 2. Using the RAC, we will determine which of the five BSPAN1 counties have capacity to manage and sustain the Outreach \& Health Promotion and Delivery \& Navigation components of the program (High Capacity), and which have the capacity to manage and sustain only the Outreach \& Health Promotion component (Medium Capacity). 3. Expand BSPAN to 12 new rural and underserved counties according to RAC score and evaluate each county's ability to implement program components and increase comprehensive mammography and appropriate follow-up. | Behavioural | BSPAN Expansion |
Primary outcome
Survey items measuring delivery of comprehensive mammography services and appropriate follow-up for women in rural and underserved counties.
Time frame: 3 years
We will use NVivo 9.0 (QSR International, Melbourne AUS) to collate and analyze data from site visits notes, semi-structured interviews, and document analysis. NVivo, a well-respected qualitative data analysis software program, makes the analysis process transparent so that investigators can track their evolving analysis. Led by Drs. Lee and Inrig, the evaluation team and their staff will organize these codes into a codebook that relates data to behavioral and organizational theory. Regular meetings will enable the BSPAN evaluation team to test emergent themes and interpretation against the knowledge base of experts in clinical medicine (e.g. Argenbright), organizational behavior (Inrig, Lee), and screening behavior (Tiro). Cross-analysis of data from all sources will allow us to conduct an integrated analysis across BSPAN components to assess key steps and interface of mammography screening and appropriate follow-up.
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 23 Apr 2018.
- 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.
Simon Lee, PhD principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing BSPAN in people with Breast Cancer in Situ, run by University of Texas Southwestern Medical Center.
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 7 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 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Survey items measuring delivery of comprehensive mammography services and appropriate follow-up for women in rural and underserved counties. (time frame: 3 years). 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 23 Apr 2018.