N/A
N=1,436
Implementing Systematic Distress Screening in Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02941614 ↗Enrolled (actual)
1,436
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Number of Participants Offered and Screened for Distress — 596; 3 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Distress screening (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kaiser Permanente
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Offered and Screened for Distress |
596; 3 | — |
| PRIMARY Number of Participants Offered an Appropriate Referral |
51; 0 | — |
| SECONDARY Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B) |
104.5; 104.6; 20.8; 20.5; 21.2; 21.4 | 0.92 |
| SECONDARY Breast Cancer Prevention Trial (BCPT) Symptom Checklist |
0.9; 1.0; 1.2; 1.2; 0.4; 0.5 | 0.59 |
| SECONDARY Number of Patients With Oncology Visit |
728; 683 | 0.006 sig |
| SECONDARY Number of Patients With Primary Care Visit |
648; 616 | 0.356 |
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.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed with initial breast cancer, any stage, any histology type
- Kaiser Permanente member for at least 100 days during study period
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT02941614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.