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

Breast Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02483377
• Other study ID #: 1B-14-7
• Secondary ID: NCI-2015-003511B
• Status: Terminated
• Phase: N/A
• First received: June 24, 2015
• Last updated: April 18, 2017
• Start date: March 5, 2015
• Est. completion date: February 7, 2017

Study information

• Verified date: April 2017
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: February 7, 2017
• Est. primary completion date: February 7, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Questionnaire scores will be expressed as median values with 95% confidence intervals.	Up to 12 months
Primary	Number of patients enrolled on clinical trials (interventional and non-interventional)	Number of patients enrolled on clinical trials (interventional and non-interventional) will be quantified and compared to historical controls.	Up to 12 months
Primary	Number of special referrals made	Number of special referrals made (eg. social worker, genetic counseling, fertility) through the navigation system will quantified and compared to historical controls.	Up to 12 months
Primary	Overall experience with breast cancer (broadly) and at LAC+USC as measured by experience-based questionnaire		Up to 12 months
Primary	Usefulness, accessibility, and quality of the patient navigation model as measured by Continuity/Coordination of Care Questionnaire (CCCQ)	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.	Up to 12 months