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Patient Navigation and Tailored Treatment Planning in Latina Patients With Breast Cancer

Terminated
Conditions
Breast Carcinoma
Interventions
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Registration Number
NCT02483377
Lead Sponsor
University of Southern California
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
Female
Target Recruitment
13
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)
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Exclusion Criteria
  • Inability to sign informed consent or complete questionnaires and forms
  • Self-identified as non-Latina (or non-Hispanic)
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Observational (treatment summaries and plan report)Quality-of-Life AssessmentPatients 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.
Observational (treatment summaries and plan report)Questionnaire AdministrationPatients 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.
Primary Outcome Measures
NameTimeMethod
Number of patients enrolled on clinical trials (interventional and non-interventional)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 CCCQUp to 12 months

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

Number of special referrals madeUp 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 questionnaireUp to 12 months
Usefulness, accessibility, and quality of the patient navigation model as measured by Continuity/Coordination of Care Questionnaire (CCCQ)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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center

🇺🇸

Los Angeles, California, United States

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