Aim 3, Adapting and Implementing Evidence-based Breast Cancer Follow-up in Primary Care

NCT ID: NCT05400941

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 910 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-24
• Study Completion Date: 2026-12-31

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.

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).

Conditions

Cancer, Breast; Health Care Utilization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Practice Led Intervention

Clinic staff will participate in learning collaborative and practice facilitation as well as receive expert consultation and audit and feedback.

Group Type: ACTIVE_COMPARATOR

Practice Led Intervention

Intervention Type: BEHAVIORAL

This is a quality improvement intervention that includes learning collaboratives, practice facilitation, expert consultation and audit and feedback.

Standard of Care

No intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Practice Led Intervention

This is a quality improvement intervention that includes learning collaboratives, practice facilitation, expert consultation and audit and feedback.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Shawna V. Hudson, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shawna V Hudson, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

Locations

Rutgers University

New Brunswick, New Jersey, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37946132 (View on PubMed)

Other Identifiers

R01CA257197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro2021000838

Identifier Type: -

Identifier Source: org_study_id