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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00937989
First received: July 10, 2009
Last updated: January 30, 2012
Last verified: January 2012

July 10, 2009
January 30, 2012
November 2008
May 2011   (final data collection date for primary outcome measure)
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Navigation and care (patient's satisfaction and value, provider's perception of barriers) [ Time Frame: 3, 6 and 9 months after starting the study. ] [ Designated as safety issue: No ]
  • Barrier resolution (information, transportation, appointments, and communication) and time to resolution [ Designated as safety issue: No ]
  • Quality of life (psychological, physical, social, and spiritual well-being) [ Designated as safety issue: No ]
  • Navigation and care (patient's satisfaction and value, provider's perception of barriers) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00937989 on ClinicalTrials.gov Archive Site
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Study of Barriers to Beginning and Finishing Treatment for Patients With Breast Cancer
Patient Navigation in Breast Cancer Care; Addressing Barriers to Treatment Initiation, Completion, and Follow Up

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Breast Cancer
  • 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.
  • Other: 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.
  • Other: medical chart review
    Baseline, 3, 6 and 9 months after starting the study
  • Other: questionnaire administration
    Baseline, 3, 6 and 9 months after starting the study
  • Other: 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
Not Provided
May 2011   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00937989
08092, P30CA033572, CHNMC-08092, CDR0000629952
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Rebecca Crane-Okada, PhD Beckman Research Institute
City of Hope Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP