Clinical trial NCT02483377: Patient Navigation and Tailored Treatment Planning in Latina Patients With Breast Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Carcinoma
Keywords: Sign or Symptom
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-06-26
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Self-identified Latina (or Hispanic) who is receiving ongoing care at LAC+USC Medical Center will be recruited.

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.

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)

Primary outcomes:
measure: 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
timeFrame: Up to 12 months
measure: Number of patients enrolled on clinical trials (interventional and non-interventional)
timeFrame: Up to 12 months
measure: Number of special referrals made
timeFrame: Up to 12 months
measure: Overall experience with breast cancer (broadly) and at LAC+USC as measured by experience-based questionnaire
timeFrame: Up to 12 months
measure: Usefulness, accessibility, and quality of the patient navigation model as measured by Continuity/Coordination of Care Questionnaire (CCCQ)
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Heather Macdonald
role: PRINCIPAL_INVESTIGATOR
References: