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Implementing Systematic Distress Screening in Breast Cancer

NCT02941614 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1436

Last updated 2020-07-07

Study results available
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Summary

Many breast cancer patients experience psychological distress during their cancer care journey. There are effective treatments for breast cancer patients experiencing distress, such as individual or group therapy, health education, and medication. Unfortunately, clinicians may not be aware of the symptoms of distress in their breast cancer patients, and some breast cancer patients who could benefit from referral to behavioral health specialists are overlooked. New guidelines recommend that all cancer patients be regularly screened for distress. However, there are unanswered questions about the impact of distress screening conducted on a large scale. Few studies have evaluated the impact of distress screening on important outcomes in breast cancer patients, such as patient experience and use of health care services, as compared to the usual care offered by the health care organization. In addition, oncology clinicians may be uncertain about the benefits of large-scale distress screening, and pilot screening programs have not been uniformly successful particularly in the community oncology setting.

The overarching goals of this study are to assess the effectiveness of implementing a guideline-recommended distress screening program for newly diagnosed breast cancer patients on improving identification and referral to treatment for highly distressed breast cancer patients, to assess patient-reported outcomes, health services utilization, and implementation outcomes of the program. This study will address two main research questions: 1) Evaluate the effectiveness of a guideline-recommended distress screening program for breast cancer patients in improving identification of distressed patients, initiation and completion of referrals to behavioral health, and patient-reported and utilization outcomes as compared to usual care; 2) Identify the barriers, facilitators, and other implementation-related outcomes related to distress screening in the community oncology setting.

Please note: This study did not require a DSMB, as it falls under the exception for low-risk behavioral studies.

Conditions

Interventions

BEHAVIORAL

Distress screening

A brief depression and anxiety screening instrument, the Patient Health Questionnaire-9 (PHQ-9), will be administered to newly diagnosed breast cancer patients in the Distress Screening arm.

Sponsors & Collaborators

  • California Breast Cancer Research Program

    collaborator OTHER

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Erin E Hahn, PhD · Kaiser Permanente

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-02
Primary Completion
2019-11-30
Completion
2019-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02941614 on ClinicalTrials.gov