Study of Barriers to Beginning and Finishing Treatment for Patients With Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00937989|
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : June 8, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: educational intervention Other: informational intervention Other: medical chart review Other: questionnaire administration Other: study of socioeconomic and demographic variables Procedure: quality-of-life assessment||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Patient Navigation in Breast Cancer Care; Addressing Barriers to Treatment Initiation, Completion, and Follow Up|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
Other: educational intervention
- 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. ]
- 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. ]
- Navigation and care (patient's satisfaction and value, provider's perception of barriers) [ Time Frame: 3, 6 and 9 months after starting the study. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937989
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Rebecca Crane-Okada, PhD||City of Hope Comprehensive Cancer Center|