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

NCT02483377 | Terminated DMC

• 3 other identifiers: 1B-14-7NCI-2015-00351P30CA014089
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma

Keywords

Sign or Symptom

Outcome Measures

Primary Outcomes (5)

• 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

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

  Up to 12 months

• Number of patients enrolled on clinical trials (interventional and non-interventional)

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

  Up to 12 months

• Number of special referrals made

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

  Up to 12 months

• Overall experience with breast cancer (broadly) and at LAC+USC as measured by experience-based questionnaire

  Up to 12 months

• Usefulness, accessibility, and quality of the patient navigation model as measured by Continuity/Coordination of Care Questionnaire (CCCQ)

  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.

  Up to 12 months

Study Arms (1)

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; Other: Questionnaire Administration

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Observational (treatment summaries and plan report)

Questionnaire Administration OTHER

Complete questionnaires

Observational (treatment summaries and plan report)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Inability to sign informed consent or complete questionnaires and forms
• Self-identified as non-Latina (or non-Hispanic)

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Signs and Symptoms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Signs and Symptoms

Study Officials

• Heather Macdonald

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: June 26, 2015
• Study Start: March 5, 2015
• Primary Completion: February 7, 2017
• Study Completion: February 7, 2017
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

US (1)