An interventional study of BSPAN in Breast Cancer in Situ, sponsored by University of Texas Southwestern Medical Center. Completed. Open to female participants aged 40 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-23.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Health services research
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.
Specific aims are to:
363 studies on the registry are indexed under Carcinoma in Situ; 47 are open to participants now.
This study's enrollment of 18,540 is above the median of 60 across 272 interventional studies indexed under Carcinoma in Situ.
Browse Carcinoma in Situ studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
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Inclusion Criteria:
Inclusion criteria for patient participants include:
Inclusion criteria for key county actors include:
Exclusion Criteria:
Exclusion criteria for patient participants:
Exclusion criteria for key county actors:
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.
Behavioral: BSPAN
1. 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.
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.
Time frame: 3 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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University of Texas Southwestern Medical Center