Aim 3, Adapting and Implementing Evidence-based Breast Cancer Follow-up in Primary Care
Primary Purpose
Cancer, Breast, Health Care Utilization
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Practice Led Intervention
Sponsored by

About this trial
This is an interventional health services research trial for Cancer, Breast
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
Sites / Locations
- Rutgers University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Practice Led Intervention
Standard of Care
Arm Description
Clinic staff will participate in learning collaborative and practice facilitation as well as receive expert consultation and audit and feedback.
No intervention.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05400941
First Posted
May 23, 2022
Last Updated
August 14, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05400941
Brief Title
Aim 3, Adapting and Implementing Evidence-based Breast Cancer Follow-up in Primary Care
Official Title
Adapting and Implementing Evidence-based Breast Cancer Follow-up in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast, Health Care Utilization
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
910 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Practice Led Intervention
Arm Type
Active Comparator
Arm Description
Clinic staff will participate in learning collaborative and practice facilitation as well as receive expert consultation and audit and feedback.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
No intervention.
Intervention Type
Behavioral
Intervention Name(s)
Practice Led Intervention
Intervention Description
This is a quality improvement intervention that includes learning collaboratives, practice facilitation, expert consultation and audit and feedback.
Primary Outcome Measure Information:
Title
Change in Comprehensive Breast Cancer Follow-up Care
Description
Percent of eligible recommendations performed per patient to assess the comprehensiveness of the follow up care received
Time Frame
Repeated measures at baseline, 6 months, 12 months, 18 months and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shawna V Hudson, PhD
Phone
848-932-0215
Email
hudsonsh@rwjms.rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawna V Hudson, PhD
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Aim 3, Adapting and Implementing Evidence-based Breast Cancer Follow-up in Primary Care
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