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Clinical Trials/NCT02483377
NCT02483377
Terminated
N/A

Breast Cancer Patient Navigation and Tailored Treatment Planning: A Process Evaluation Study for LAC+USC Patient Navigation, Treatment Planning, and Ongoing Support for Latina Women

University of Southern California1 site in 1 country13 target enrollmentMarch 5, 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast Carcinoma
Sponsor
University of Southern California
Enrollment
13
Locations
1
Primary Endpoint
Number of patients enrolled on clinical trials (interventional and non-interventional)
Status
Terminated
Last Updated
9 years ago

Overview

Brief Summary

This research trial studies how well patient navigation and tailored treatment planning work in Latina patients with breast cancer. Patient navigation and tailored treatment planning may provide extra support by guiding patients through the healthcare system, remove barriers to care and provide ease of access to essential resources, encourage patient participation in their care, provide in-language summaries and plans for follow-up care, improve patient access to needed supportive care services and may improve general healthcare experience in Latina patients with breast cancer.

Detailed Description

PRIMARY OBJECTIVES: I. Successful navigation of patients being screened or treated for breast cancer through the continuum of their care (from visit to visit; from surgical care to radiologic care to oncologic care; from oncologic care to supportive care; etc). II. Supply individualized in-language treatment summaries and follow-up care plans to enrolled patients. III. Supply tailored in-language survivorship plan summaries to enrolled patients. OUTLINE: Patients receive treatment summaries and plan report that captures patient data through the use of an "intake checklist" completed during the initial consultation with the breast oncology team and used to guide referrals to existing services and programmed with generic information related to disease and treatment management plan. Additional elements, such as psycho-social services, exercise, and/or nutrition, identified by the patient self-report, will be incorporated. Patients also complete 3 questionnaires at each clinic visit. After completion of study, patients are followed up at 6 months or 12 months.

Registry
clinicaltrials.gov
Start Date
March 5, 2015
End Date
February 7, 2017
Last Updated
9 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients receiving ongoing care at LAC+USC
  • Self-identified as Latina (or Hispanic)
  • Known or suspected breast cancer
  • Being seen in a breast cancer high risk, screening or prevention program or clinic or in one of the breast cancer clinics (surgical or medical oncology)

Exclusion Criteria

  • Inability to sign informed consent or complete questionnaires and forms
  • Self-identified as non-Latina (or non-Hispanic)

Outcomes

Primary Outcomes

Number of patients enrolled on clinical trials (interventional and non-interventional)

Time Frame: Up to 12 months

Number of patients enrolled on clinical trials (interventional and non-interventional) will be quantified and compared to historical controls.

Number of missed appointments from the time of initial diagnosis to the completion of primary treatment (chemotherapy, surgery and radiation as applicable) as measured by CCCQ

Time Frame: Up to 12 months

Questionnaire scores will be expressed as median values with 95% confidence intervals.

Number of special referrals made

Time Frame: Up to 12 months

Number of special referrals made (eg. social worker, genetic counseling, fertility) through the navigation system will quantified and compared to historical controls.

Overall experience with breast cancer (broadly) and at LAC+USC as measured by experience-based questionnaire

Time Frame: Up to 12 months

Usefulness, accessibility, and quality of the patient navigation model as measured by Continuity/Coordination of Care Questionnaire (CCCQ)

Time Frame: Up to 12 months

Means and standard deviations will be summarized per outcome measures at 3, 6, and 12 months after baseline, and 95% confidence intervals for the difference in means will be calculated for each assessment time for total scores and subscale scores.

Study Sites (1)

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