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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA257197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Practice Led Intervention | Active Comparator | Clinic staff will participate in learning collaborative and practice facilitation as well as receive expert consultation and audit and feedback. |
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| Standard of Care | No Intervention | No intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Practice Led Intervention | Behavioral | This is a quality improvement intervention that includes learning collaboratives, practice facilitation, expert consultation and audit and feedback. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shawna V Hudson, PhD | Rutgers University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers University | New Brunswick | New Jersey | 08901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42001107 | Derived | 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. | |
| 41844926 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 37946132 | Derived | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |