NCT05400941

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
910

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jun 2024Dec 2026

First Submitted

Initial submission to the registry

May 23, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
2.1 years until next milestone

Study Start

First participant enrolled

June 24, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

2.1 years

First QC Date

May 23, 2022

Last Update Submit

May 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Practice Led Intervention

ACTIVE COMPARATOR

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

Behavioral: Practice Led Intervention

Standard of Care

NO INTERVENTION

No intervention.

Interventions

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

Practice Led Intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identification as a staff member or patient who has had breast cancer in a participating practice

You may not qualify if:

  • Unable to speak, understand and/or read English
  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (2)

  • Fadem SJ, Maniaci A, Devine KA, O'Malley DM, Hemler JR, Holover G, Hudson SV, Crabtree BF. "I had to work it out for myself": opportunities for primary care to fill a void for early-onset breast cancer survivors. J Cancer Surviv. 2026 Mar 18. doi: 10.1007/s11764-026-02001-9. Online ahead of print.

  • Fadem SJ, Crabtree BF, O'Malley DM, Mikesell L, Ferrante JM, Toppmeyer DL, Ohman-Strickland PA, Hemler JR, Howard J, Bator A, April-Sanders A, Kurtzman R, Hudson SV. Adapting and implementing breast cancer follow-up in primary care: protocol for a mixed methods hybrid type 1 effectiveness-implementation cluster randomized study. BMC Prim Care. 2023 Nov 9;24(1):235. doi: 10.1186/s12875-023-02186-3.

MeSH Terms

Conditions

Breast NeoplasmsPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Shawna V Hudson, PhD

    Rutgers University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 23, 2022

First Posted

June 2, 2022

Study Start

June 24, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations