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OpenTrials
Completed

NCT Number: NCT00937989

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

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

Other

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

Other

Baseline, 3, 6 and 9 months after starting the study

Questionnaire Administration

Other

Baseline, 3, 6 and 9 months after starting the study

study of socioeconomic and demographic variables

Other

Baseline, 3, 6 and 9 months after starting the study

quality-of-life assessment

Procedure

Baseline, 3, 6 and 9 months after starting the study

Primary outcomes

  1. 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.

  2. 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.

  3. Navigation and care (patient's satisfaction and value, provider's perception of barriers)

    Time frame: 3, 6 and 9 months after starting the study.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 13, 2009
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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