Aim 3, Adapting and Implementing Evidence-based Breast Cancer Follow-up in Primary Care
Adapting and Implementing Evidence-based Breast Cancer Follow-up in Primary Care
2 other identifiers
interventional
910
1 country
1
Brief Summary
This mixed methods study evaluates the effectiveness of an organizational intervention to enhance implementation of strategies to increase breast cancer survivorship symptom and risk management.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2022
CompletedFirst Posted
Study publicly available on registry
June 2, 2022
CompletedStudy Start
First participant enrolled
June 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 6, 2026
May 1, 2026
2.1 years
May 23, 2022
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Comprehensive Breast Cancer Follow-up Care
Percent of eligible recommendations performed per patient to assess the comprehensiveness of the follow up care received
Repeated measures at baseline, 6 months, 12 months, 18 months and 24 months
Study Arms (2)
Practice Led Intervention
ACTIVE COMPARATORClinic staff will participate in learning collaborative and practice facilitation as well as receive expert consultation and audit and feedback.
Standard of Care
NO INTERVENTIONNo intervention.
Interventions
This is a quality improvement intervention that includes learning collaboratives, practice facilitation, expert consultation and audit and feedback.
Eligibility Criteria
You may qualify if:
- Self-identification as a staff member or patient who has had breast cancer in a participating practice
You may not qualify if:
- Unable to speak, understand and/or read English
- Unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rutgers University
New Brunswick, New Jersey, 08901, United States
Related Publications (2)
Fadem SJ, Maniaci A, Devine KA, O'Malley DM, Hemler JR, Holover G, Hudson SV, Crabtree BF. "I had to work it out for myself": opportunities for primary care to fill a void for early-onset breast cancer survivors. J Cancer Surviv. 2026 Mar 18. doi: 10.1007/s11764-026-02001-9. Online ahead of print.
PMID: 41844926DERIVEDFadem SJ, Crabtree BF, O'Malley DM, Mikesell L, Ferrante JM, Toppmeyer DL, Ohman-Strickland PA, Hemler JR, Howard J, Bator A, April-Sanders A, Kurtzman R, Hudson SV. Adapting and implementing breast cancer follow-up in primary care: protocol for a mixed methods hybrid type 1 effectiveness-implementation cluster randomized study. BMC Prim Care. 2023 Nov 9;24(1):235. doi: 10.1186/s12875-023-02186-3.
PMID: 37946132DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shawna V Hudson, PhD
Rutgers University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 23, 2022
First Posted
June 2, 2022
Study Start
June 24, 2024
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share