ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02483377
Recruitment Status : Terminated (Principal Investigator left)
First Posted : June 26, 2015
Last Update Posted : April 20, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

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
Breast Carcinoma Other: Quality-of-Life Assessment Other: Questionnaire Administration

Detailed Description:

PRIMARY OBJECTIVES:

I. 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).

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

III. 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 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 : March 5, 2015
Actual Primary Completion Date : February 7, 2017
Actual Study Completion Date : February 7, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort 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 Name: Quality of Life Assessment

Other: Questionnaire Administration
Complete questionnaires




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Self-identified Latina (or Hispanic) who is receiving ongoing care at LAC+USC Medical Center will be recruited.
Criteria

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)

Information from the National Library of Medicine

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): NCT02483377


Locations
United States, California
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

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02483377     History of Changes
Other Study ID Numbers: 1B-14-7
NCI-2015-00351 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
1B-14-7 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 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:
Sign or Symptom

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases