Aim 3, Adapting and Implementing Evidence-based Breast Cancer Follow-up in Primary Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Practice Led Intervention.
- Who it may be relevant to
- Registry conditions: Cancer, Breast, Health Care Utilization. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Adapting and Implementing Evidence-based Breast Cancer Follow-up in Primary Care
Overview
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.
Detailed description
Aim 3 is a hybrid type 1 effectiveness-implementation cluster randomized study with a waitlist control in 26 primary care practices. This study uses a tailored combination of practice facilitation, expert consultation, collaborative learning events, and audit and feedback as intervention strategies, and a mixed-methods comparative case study learning evaluation for primary care practices to adapt priority recommendations of evidence-based activities for breast cancer survivorship care. Intervention effectiveness will be assessed in two groups of clinics: 13 cases that will receive the implementation intervention and 13 waitlist controls. Impact of this implementation will be measured using mixed methods to assess Exploration, Preparation, Implementation and Sustainment factors related to how organizational and contextual variables affect adoption, implementation and early sustainability for provision of follow-up care, symptom, and risk management activities at 6 and 12 months post implementation. Aim 3 surveys 20 clinicians and staff members from 26 intervention practices (n=520) and conducts key informant interviews with 5 health care team members (who have participated in the survey; n=130) and 15 breast cancer survivors per practice (n=390; 5 per assessment point at baseline, 6 months and 12 months post intervention). Medical records of 20 patients with a history of breast cancer per practice per assessment point at baseline, 6 months and 12 months post intervention will be randomly selected for review (N=1,560) to assess and compare comprehensive breast cancer follow-up care outcomes. Sustainment will be measured through continued monitoring of the medical records for the 13 initial intervention practices at 18 and 24 months (N=520).
Interventions
- Behavioral Practice Led Intervention
This is a quality improvement intervention that includes learning collaboratives, practice facilitation, expert consultation and audit and feedback.
Primary outcome measures
- Change in Comprehensive Breast Cancer Follow-up Care [Time frame: Repeated measures at baseline, 6 months, 12 months, 18 months and 24 months]
Eligibility criteria
Inclusion criteria
- Self-identification as a staff member or patient who has had breast cancer in a participating practice
Exclusion criteria
- Unable to speak, understand and/or read English
- Unable to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Rutgers University — New Brunswick
Publications
- Fadem SJ, Hudson SV, Crabtree BF, Howard J, Hemler JR, Ferrante J, Mikesell L, April-Sanders AK, Bator A, O'Malley DM. Using co-design to develop actionable strategies to identify and follow-up on breast cancer survivors in primary care. BMC Health Serv Res. 2026 Apr 18;26(1):777. doi: 10.1186/s12913-026-14538-7. PMID 42001107
- 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 18:10.1007/s11764-026-02001-9. doi: 10.1007/s11764-026-02001-9. Online ahead of print. PMID 41844926
- Fadem 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 37946132
Identifiers
NCT: NCT05400941 · Pro2021000838 · R01CA257197