Patient Navigation and Tailored Treatment Planning in Latina Patients With Breast Cancer

Sponsor
University of Southern California (Other)
Overall Status
Terminated
CT.gov ID
NCT02483377
Collaborator
National Cancer Institute (NCI) (NIH)
13
1
23.2
0.6

Study Details

Study Description

Brief Summary

This research trial studies how well patient navigation and tailored treatment planning work in Latina patients with breast cancer. Patient navigation and tailored treatment planning may provide extra support by guiding patients through the healthcare system, remove barriers to care and provide ease of access to essential resources, encourage patient participation in their care, provide in-language summaries and plans for follow-up care, improve patient access to needed supportive care services and may improve general healthcare experience in Latina patients with breast cancer.

Condition or Disease Intervention/Treatment Phase
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVES:
  1. Successful navigation of patients being screened or treated for breast cancer through the continuum of their care (from visit to visit; from surgical care to radiologic care to oncologic care; from oncologic care to supportive care; etc).

  2. Supply individualized in-language treatment summaries and follow-up care plans to enrolled patients.

  3. Supply tailored in-language survivorship plan summaries to enrolled patients.

OUTLINE:

Patients receive treatment summaries and plan report that captures patient data through the use of an "intake checklist" completed during the initial consultation with the breast oncology team and used to guide referrals to existing services and programmed with generic information related to disease and treatment management plan. Additional elements, such as psycho-social services, exercise, and/or nutrition, identified by the patient self-report, will be incorporated. Patients also complete 3 questionnaires at each clinic visit.

After completion of study, patients are followed up at 6 months or 12 months.

Study Design

Study Type:
Observational
Actual Enrollment :
13 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Breast Cancer Patient Navigation and Tailored Treatment Planning: A Process Evaluation Study for LAC+USC Patient Navigation, Treatment Planning, and Ongoing Support for Latina Women
Actual Study Start Date :
Mar 5, 2015
Actual Primary Completion Date :
Feb 7, 2017
Actual Study Completion Date :
Feb 7, 2017

Arms and Interventions

Arm Intervention/Treatment
Observational (treatment summaries and plan report)

Patients receive treatment summaries and plan report that captures patient data through the use of an "intake checklist" completed during the initial consultation with the breast oncology team and used to guide referrals to existing services and programmed with generic information related to disease and treatment management plan. Additional elements, such as psycho-social services, exercise, and/or nutrition, identified by the patient self-report, will be incorporated. Patients also complete 3 questionnaires at each clinic visit.

Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Complete questionnaires

    Outcome Measures

    Primary Outcome Measures

    1. Number of missed appointments from the time of initial diagnosis to the completion of primary treatment (chemotherapy, surgery and radiation as applicable) as measured by CCCQ [Up to 12 months]

      Questionnaire scores will be expressed as median values with 95% confidence intervals.

    2. Number of patients enrolled on clinical trials (interventional and non-interventional) [Up to 12 months]

      Number of patients enrolled on clinical trials (interventional and non-interventional) will be quantified and compared to historical controls.

    3. Number of special referrals made [Up to 12 months]

      Number of special referrals made (eg. social worker, genetic counseling, fertility) through the navigation system will quantified and compared to historical controls.

    4. Overall experience with breast cancer (broadly) and at LAC+USC as measured by experience-based questionnaire [Up to 12 months]

    5. Usefulness, accessibility, and quality of the patient navigation model as measured by Continuity/Coordination of Care Questionnaire (CCCQ) [Up to 12 months]

      Means and standard deviations will be summarized per outcome measures at 3, 6, and 12 months after baseline, and 95% confidence intervals for the difference in means will be calculated for each assessment time for total scores and subscale scores.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients receiving ongoing care at LAC+USC

    • Self-identified as Latina (or Hispanic)

    • Known or suspected breast cancer

    • Being seen in a breast cancer high risk, screening or prevention program or clinic or in one of the breast cancer clinics (surgical or medical oncology)

    Exclusion Criteria:
    • Inability to sign informed consent or complete questionnaires and forms

    • Self-identified as non-Latina (or non-Hispanic)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033

    Sponsors and Collaborators

    • University of Southern California
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Heather Macdonald, University of Southern California

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Southern California
    ClinicalTrials.gov Identifier:
    NCT02483377
    Other Study ID Numbers:
    • 1B-14-7
    • NCI-2015-00351
    • 1B-14-7
    • P30CA014089
    First Posted:
    Jun 26, 2015
    Last Update Posted:
    Apr 20, 2017
    Last Verified:
    Apr 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Southern California
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 20, 2017