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

Rutgers The State University of New Jersey

Status: Not yet enrolling

Conditions: Cancer, Breast; Health Care Utilization

Treatments: Behavioral: Practice Led Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05400941

Pro2021000838

R01CA257197 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 910 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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910 participants in 2 patient groups

Practice Led Intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Practice Led Intervention

Standard of Care

No Intervention group

Description:

No intervention.