Implementing Systematic Distress Screening in Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02941614|
Recruitment Status : Recruiting
First Posted : October 21, 2016
Last Update Posted : May 9, 2018
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 such a large scale. Few studies have evaluated the impact of distress screening on important outcomes in breast cancer patients, such as patient experience, symptom management, and use of health care services, as compared to the usual care offered by the health care organization. In addition, oncology clinicians are 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) Is a community-oncology based, large-scale distress screening program more effective than usual care on improved identification of distressed patients, referral to behavioral health services, and patient-reported outcomes for breast cancer patients? 2) What are the barriers, facilitators, and other implementation-related outcomes related to distress screening in the community oncology setting?
|Condition or disease||Intervention/treatment|
|Breast Cancer||Behavioral: Distress screening|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||Implementing Systematic Distress Screening in Breast Cancer|
|Actual Study Start Date :||October 2, 2017|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
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).
Behavioral: Distress screening
A brief depression and anxiety screening instrument, the Patient Health Questionnaire (PHQ), will be administered to newly diagnosed breast cancer patients in the Distress Screening arm. The PHQ starts with a 2-item screen, and branches to the full screening instrument as needed.
Newly diagnosed breast cancer patients will experience usual care.
- Proportion screened for distress [ Time Frame: 1 year ]
- Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B) [ Time Frame: 18 months ]
- Breast Cancer Prevention Trial (BCPT) Symptom Checklist [ Time Frame: 18 months ]
- Utilization of behavioral health services [ Time Frame: 24 months ]Between group comparison of number of visits with behavioral health providers
- Utilization of emergency and urgent care services [ Time Frame: 24 months ]Between group comparison of number of visits to emergency and urgent care services
- Organizational Readiness to Change Assessment [ Time Frame: 12 months ]Validated survey instrument which operationalizes the Consolidated Framework for Implementation Research (CFIR) domains for measurement
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): NCT02941614
|Contact: Erin E Hahn, PhD||626-564-3505||Erin.E.Hahn@kp.org|
|Contact: Corrine Munoz-Plaza, MPH||626-564-3094||Corrine.E.Munoz-Plaza@kp.org|
|United States, California|
|Anaheim Medical Center||Recruiting|
|Anaheim, California, United States, 92806|
|Contact: Farah Brasfield, MD|
|South Bay - Harbor City Medical Center||Recruiting|
|Harbor City, California, United States, 90710|
|Contact: Lara Durna, MD|
|Los Angeles Medical Center||Recruiting|
|Los Angeles, California, United States, 90027|
|Contact: Karen Kwan, MD|
|Principal Investigator:||Erin E Hahn, PhD||Kaiser Permanente Southern California|