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

Not Applicable

• Conditions: Health Care Utilization; Cancer, Breast
• Interventions: Behavioral: Practice Led Intervention

• Registration Number: NCT05400941
• Lead Sponsor: Rutgers, The State University of New Jersey

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).

Study Timeline

• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-05-27
• Study First Posted: 2022-06-02
• Study Start: 2024-06-24
• Status Verified: 2024-11
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-07-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 910

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Practice Led Intervention	Practice Led Intervention	Clinic staff will participate in learning collaborative and practice facilitation as well as receive expert consultation and audit and feedback.

Primary Outcome Measures

Name	Time	Method
Change in Comprehensive Breast Cancer Follow-up Care	Repeated measures at baseline, 6 months, 12 months, 18 months and 24 months	Percent of eligible recommendations performed per patient to assess the comprehensiveness of the follow up care received

Trial Locations

Locations (1)

Rutgers University; 🇺🇸 New Brunswick, New Jersey, United States