Implementing Systematic Distress Screening in Breast Cancer
1 other identifier
observational
1,436
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2017
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2016
CompletedFirst Posted
Study publicly available on registry
October 21, 2016
CompletedStudy Start
First participant enrolled
October 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedResults Posted
Study results publicly available
July 7, 2020
CompletedJuly 7, 2020
June 1, 2020
2.2 years
October 17, 2016
April 13, 2020
June 22, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants Offered and Screened for Distress
\# of newly diagnosed breast cancer patients offered and screened with the Patient Health Questionnaire 9 at their initial consult
Patients assessed during initial consult - e.g. 1 day during 60 min consult
Number of Participants Offered an Appropriate Referral
For patients who had screening done in Oncology, appropriate action for those with a medium/high PHQ-9 is a referral to social work, psychiatry, depression care management.
Patients assessed during initial consult - e.g. 1 day during 60 min consult
Secondary Outcomes (4)
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
12 months
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
12 months
Number of Patients With Oncology Visit
18 months
Number of Patients With Primary Care Visit
18 months
Other Outcomes (2)
Number of Participants Utilizing Behavioral Health Services
18 months
Number of Participants Utilizing Emergency and Urgent Care Services
18 months
Study Arms (2)
Intervention
Newly diagnosed breast cancer patients will be offered a brief distress screening questionnaire, the Patient Health Questionnaire (PHQ), around the time of their breast cancer diagnosis and again at subsequent transitions in care as appropriate (e.g., the initiation of chemotherapy).
Control
Newly diagnosed breast cancer patients will experience usual care.
Interventions
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.
Eligibility Criteria
Newly diagnosed breast cancer patients
You may qualify if:
- Newly diagnosed with initial breast cancer, any stage, any histology type
- Kaiser Permanente member for at least 100 days during study period
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kaiser Permanentelead
- California Breast Cancer Research Programcollaborator
Study Sites (6)
Anaheim Medical Center
Anaheim, California, 92806, United States
Baldwin Park Medical Center
Baldwin Park, California, 91706, United States
South Bay - Harbor City Medical Center
Harbor City, California, 90710, United States
Los Angeles Medical Center
Los Angeles, California, 90027, United States
West Los Angeles Medical Center
Los Angeles, California, 90034, United States
Woodland Hills Medical Center
Woodland Hills, California, 91364, United States
Related Publications (2)
Hahn EE, Munoz-Plaza CE, Lyons LJ, Lee JS, Pounds D, La Cava S, Brasfield FM, Durna LN, Kwan KW, Beard DB, Ferreira A, Gould MK. Barriers and facilitators to implementation and sustainment of guideline-recommended depression screening for patients with breast cancer in medical oncology: a qualitative study. Support Care Cancer. 2023 Jul 12;31(8):461. doi: 10.1007/s00520-023-07922-0.
PMID: 37436477DERIVEDHahn EE, Munoz-Plaza CE, Pounds D, Lyons LJ, Lee JS, Shen E, Hong BD, La Cava S, Brasfield FM, Durna LN, Kwan KW, Beard DB, Ferreira A, Padmanabhan A, Gould MK. Effect of a Community-Based Medical Oncology Depression Screening Program on Behavioral Health Referrals Among Patients With Breast Cancer: A Randomized Clinical Trial. JAMA. 2022 Jan 4;327(1):41-49. doi: 10.1001/jama.2021.22596.
PMID: 34982119DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
No limitations to report
Results Point of Contact
- Title
- Erin Hahn
- Organization
- Kaiser Permanente Southern California Department of Research and Evaluation
Study Officials
- PRINCIPAL INVESTIGATOR
Erin E Hahn, PhD
Kaiser Permanente
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2016
First Posted
October 21, 2016
Study Start
October 2, 2017
Primary Completion
November 30, 2019
Study Completion
November 30, 2019
Last Updated
July 7, 2020
Results First Posted
July 7, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share