Study of Barriers to Beginning and Finishing Treatment for Patients With Breast Cancer
NCT ID: NCT00937989
Last Updated: 2015-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2008-11-30
2011-05-31
Brief Summary
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PURPOSE: This clinical trial is studying barriers to beginning and finishing treatment for patients with breast cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Interventions
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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
quality-of-life assessment
Baseline, 3, 6 and 9 months after starting the study
Eligibility Criteria
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Inclusion Criteria
* 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
50 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Rebecca Crane-Okada, PhD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Comprehensive Cancer Center
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Countries
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Other Identifiers
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CHNMC-08092
Identifier Type: -
Identifier Source: secondary_id
CDR0000629952
Identifier Type: REGISTRY
Identifier Source: secondary_id
08092
Identifier Type: -
Identifier Source: org_study_id
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