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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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05400941
Enrollment
910
Registered
2022-06-02
Start date
2024-06-24
Completion date
2026-12-31
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Breast, Health Care Utilization

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).

Interventions

BEHAVIORALPractice Led Intervention

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

Sponsors

Rutgers, The State University of New Jersey
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Comprehensive Breast Cancer Follow-up CareRepeated measures at baseline, 6 months, 12 months, 18 months and 24 monthsPercent of eligible recommendations performed per patient to assess the comprehensiveness of the follow up care received

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORShawna V Hudson, PhD

Rutgers University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026