Study of Barriers to Beginning and Finishing Treatment for Patients With Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational intervention
informational intervention
medical chart review
questionnaire administration
study of socioeconomic and demographic variables
quality-of-life assessment
Sponsored by

About this trial
This is an interventional health services research trial for Breast Cancer focused on measuring 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
Eligibility 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
Sites / Locations
- City of Hope Comprehensive Cancer Center
Outcomes
Primary Outcome Measures
Barrier resolution (information, transportation, appointments, and communication) and time to resolution
Quality of life (psychological, physical, social, and spiritual well-being)
Navigation and care (patient's satisfaction and value, provider's perception of barriers)
Secondary Outcome Measures
Full Information
NCT ID
NCT00937989
First Posted
July 10, 2009
Last Updated
June 3, 2015
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00937989
Brief Title
Study of Barriers to Beginning and Finishing Treatment for Patients With Breast Cancer
Official Title
Patient Navigation in Breast Cancer Care; Addressing Barriers to Treatment Initiation, Completion, and Follow Up
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
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
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
educational intervention
Intervention Description
Occurs weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.
Intervention Type
Other
Intervention Name(s)
informational intervention
Intervention Description
Occurs weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.
Intervention Type
Other
Intervention Name(s)
medical chart review
Intervention Description
Baseline, 3, 6 and 9 months after starting the study
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Baseline, 3, 6 and 9 months after starting the study
Intervention Type
Other
Intervention Name(s)
study of socioeconomic and demographic variables
Intervention Description
Baseline, 3, 6 and 9 months after starting the study
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Intervention Description
Baseline, 3, 6 and 9 months after starting the study
Primary Outcome Measure Information:
Title
Barrier resolution (information, transportation, appointments, and communication) and time to resolution
Time Frame
Weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.
Title
Quality of life (psychological, physical, social, and spiritual well-being)
Time Frame
Prior to starting treatment and 3, 6 and 9 months after starting the study.
Title
Navigation and care (patient's satisfaction and value, provider's perception of barriers)
Time Frame
3, 6 and 9 months after starting the study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Crane-Okada, PhD
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Barriers to Beginning and Finishing Treatment for Patients With Breast Cancer
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