Study of Barriers to Beginning and Finishing Treatment for Patients With Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937989
• Other study ID #: 08092
• Secondary ID: P30CA033572CHNMC
• Status: Completed
• Phase: N/A
• First received: July 10, 2009
• Last updated: June 3, 2015
• Start date: November 2008
• Est. completion date: May 2011

Study information

• Verified date: June 2015
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Gathering information about barriers to receiving breast cancer treatment may help doctors learn more about improving the treatment process and improve patients' quality of life.

PURPOSE: This clinical trial is studying barriers to beginning and finishing treatment for patients with breast cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• educational intervention
Occurs weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.
• informational intervention
Occurs weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.
• medical chart review
Baseline, 3, 6 and 9 months after starting the study
• questionnaire administration
Baseline, 3, 6 and 9 months after starting the study
• study of socioeconomic and demographic variables
Baseline, 3, 6 and 9 months after starting the study

Procedure:
• quality-of-life assessment
Baseline, 3, 6 and 9 months after starting the study

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Barrier resolution (information, transportation, appointments, and communication) and time to resolution		Weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.	No
Primary	Quality of life (psychological, physical, social, and spiritual well-being)		Prior to starting treatment and 3, 6 and 9 months after starting the study.	No
Primary	Navigation and care (patient's satisfaction and value, provider's perception of barriers)		3, 6 and 9 months after starting the study.	No