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

Health Care Utilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05400941
• Other study ID #: Pro2021000838
• Secondary ID: R01CA257197
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Shawna V Hudson, PhD
• Phone: 848-932-0215
• Email: hudsonsh[@]rwjms.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 910
• Est. completion date: December 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer, Breast
• Health Care Utilization

Intervention

Behavioral:
• Practice Led Intervention
This is a quality improvement intervention that includes learning collaboratives, practice facilitation, expert consultation and audit and feedback.

Locations

Country	Name	City	State
United States	Rutgers University	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Comprehensive Breast Cancer Follow-up Care	Percent of eligible recommendations performed per patient to assess the comprehensiveness of the follow up care received	Repeated measures at baseline, 6 months, 12 months, 18 months and 24 months