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Patient Navigation in Breast Cancer Care; Addressing Barriers to Treatment Initiation, Completion, and Follow Up


N/A
50 Years
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

Patient Navigation in Breast Cancer Care; Addressing Barriers to Treatment Initiation, Completion, and Follow Up


OBJECTIVES:

- Identify barriers of receiving primary breast cancer treatment for older patients with
either Medi-Cal insurance or who are 65 years of age and older.

- Describe steps and processes involved in resolution of barriers to receiving primary
breast cancer treatment for these patients.

- Identify barriers of receiving primary breast cancer treatment for patients who are
Hispanic with either Medi-Cal insurance or aged 65 years and older.

- Describe steps and processes involved in resolution of barriers to receiving primary
breast cancer treatment for these Hispanic patients.

- Describe breast cancer participants' perceptions of Patient Navigation.

- Demonstrate the significant role of a Patient Navigator in identifying and resolving
barriers to treatment.

- Increase opportunities for participation of breast cancer patients with either Medi-Cal
insurance or who are 65 years of age and older, or who are Hispanic, to breast cancer
clinical trials.

- Integrate a patient navigation program within City of Hope designed to support
underserved patients during primary treatment for breast cancer.

OUTLINE: For the first 3 months of the study, medical charts are reviewed.

Beginning in month 4, patients are introduced to the Patient Navigator who provides them
with telephone and e-mail contact on an Appointment Reminder Card, and develops a plan for
eliminating identified barriers and/or addressing immediate concerns. Patients' plans may
include contacting others on behalf of the patient, coaching the patient on how to solve a
problem, referring to resources within City of Hope (COH) or in the community, and
investigating possible solutions. Patients are also oriented to COH's services, open
clinical trials, and resources. Navigation of care includes assistance during initial and
ongoing evaluations by all cancer specialists, during initiation and completion of all
primary treatment, and through the first post-treatment follow up. Patients are contacted
weekly for 8 weeks of the study and at least once a month for 9 months.

The Patient Navigator will track identified barriers, processes to resolution, and time
required to resolve barriers.

Patients complete questionnaires at baseline, and periodically during study, on
socio-demographic, quality of life, resource-use satisfaction, and satisfaction with care
and Patient Navigator.

After completion of study intervention, patients continue to receive Patient Navigator
support for up to 30 days.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed newly diagnosed breast cancer

- Stage 0-III disease

- No metastasis or recurrent disease

- Insured with Medi-Cal OR ≥ 65 years old

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Menopausal status not specified

- English or Spanish-speaking

- Intending to receive all primary breast cancer treatment at City of Hope

PRIOR CONCURRENT THERAPY:

- No prior therapy for breast cancer

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

Barrier resolution (information, transportation, appointments, and communication) and time to resolution

Outcome Time Frame:

Weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.

Safety Issue:

No

Principal Investigator

Rebecca Crane-Okada, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Institutional Review Board

Study ID:

08092

NCT ID:

NCT00937989

Start Date:

November 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • ductal breast carcinoma in situ
  • lobular breast carcinoma in situ
  • male breast cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms

Name

Location

City of Hope Comprehensive Cancer Center Duarte, California  91010