Clinical trial · Observational
Implementing Systematic Distress Screening in Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Distress screening | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Intervention
- description
- 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).
- interventionNames
- Behavioral: Distress screening
- label
- Control
- description
- Newly diagnosed breast cancer patients will experience usual care.
Primary outcomes (2)
- measure
- Number of Participants Offered and Screened for Distress
- timeFrame
- Patients assessed during initial consult - e.g. 1 day during 60 min consult
- description
- \# of newly diagnosed breast cancer patients offered and screened with the Patient Health Questionnaire 9 at their initial consult
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDHahn 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 37436477
- DERIVEDHahn 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 34982119