Breast Cancer Clinical Trial

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

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.

View Full Description

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).

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

910

Study ID:

NCT05400941

Recruitment Status:

Not yet recruiting

Sponsor:

Rutgers, The State University of New Jersey

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Rutgers University
New Brunswick New Jersey, 08901, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

910

Study ID:

NCT05400941

Recruitment Status:

Not yet recruiting

Sponsor:


Rutgers, The State University of New Jersey

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.