- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02941614
Implementing Systematic Distress Screening in Breast Cancer
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.
Study Overview
Detailed Description
Background and Study Aims:
Breast cancer patients are at risk for physical and psychosocial harms. Among the most highly prevalent psychosocial issues in breast cancer patients is psychological distress. Distress is defined and assessed as psychiatric morbidity or prevalence of psychiatric disorders, particularly anxiety and depression. It is estimated that 40-50% of women diagnosed with early stage breast cancer will experience distress in the year following diagnosis. There is a rich literature on the persistent negative effects of distress in breast cancer patients, including associations with decreased physical and social functioning, increased symptom burden, higher utilization of inpatient and emergency services, and poor quality of life. Psychological distress can also adversely affect individual work productivity, and contributes to the rising costs of cancer care.
Recent guidelines from the American Society of Clinical Oncology (ASCO) and others recommend routine distress screening for breast cancer patients, recognizing the availability of effective treatments for psychological distress. Unfortunately distress remains under-detected and undertreated in breast cancer patients and rates of adherence to ASCO and other guidelines is very low. Low rates of screening might be explained in part by limited evidence of effectiveness: while efficacy of distress screening has been demonstrated in small-scale trials at academic centers, typically showing increases in number of referrals to psychosocial services, evidence supporting the effectiveness of large scale distress screening programs under routine practice conditions is limited. It is currently unknown if distress screening of breast cancer patients will improve identification of distressed patients or referrals to behavioral health services in non-academic settings. In addition, extant efficacy studies generally fail to measure key impacts and outcomes desired from distress screening, such as patient-reported outcomes (e.g., distress management, satisfaction) and changes in health care utilization (e.g., changes in emergency department use). Implementation-related factors and outcomes have also been largely overlooked in prior research (e.g., clinician acceptability, fidelity of delivery), leaving serious gaps in the understanding of barriers to adoption of distress screening programs and gaps in the knowledge needed to facilitate large-scale, routine implementation of screening.
The overarching goal of this study is to implement and evaluate a guideline-based distress screening program for newly diagnosed breast cancer patients, measuring its effectiveness and impacts on key outcomes and examining barriers and facilitators to routine adoption. There is a critical need for translational research to assess the effectiveness of distress screening programs in improving (a) identification of distress, (b) referral for services, (c) outcomes for breast cancer patients in real-world oncology settings, and in understanding implementation barriers and facilitators. Without evidence of effectiveness, it is unlikely that clinical and operational health system leaders will invest in distress screening programs, potentially leading to serious adverse consequences. This proposed translational research is crucial in order to bridge the gap between academic studies and non-academic, community oncology practice, where the majority of breast cancer patients are treated. In addition, gaining insight and understanding into barriers and facilitators to implementation of distress screening programs is critically important. The objectives are to assess the effectiveness of the recommended screening program from the joint task force of the American Psychosocial Oncology Society, Association of Oncology Social Work, and Oncology Nursing Society on improving identification and referral to treatment for highly distressed breast cancer patients within an integrated health care system, and to assess patient-reported outcomes, health services utilization, and implementation outcomes of the program.
Specific Aims:
Aim 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 within Kaiser Permanente Southern California (KPSC), using a pragmatic cluster randomized control trial design at six medical centers.
Aim 2: Identify patient-, clinician-, and system-level barriers and facilitators to implementation of the program, and assess stakeholder-perceived acceptability, fidelity, and achievements of the program.
Study Methods The setting for this research is Kaiser Permanente Southern California, a large, integrated health care system with 14 medical centers serving a highly diverse population of over 4 million members. The investigators will use a novel hybrid effectiveness-implementation study design that allows for dual study of the clinical effectiveness and implementation-related factors to address the need for evidence in both areas. This study will employ mixed methods, collecting both qualitative and quantitative data as appropriate to address the study aims. To evaluate effectiveness, this study will use a cluster randomized control trial (RCT) design, clustered at the medical center level, and will implement the program at the intervention sites and offering screening to all newly diagnosed breast cancer patients. To evaluate the effectiveness of the program, the investigators will collect structured data from the KPSC electronic record (referral initiation/completion, use of health services) and patient-reported data (functioning, symptom management). Existing work from a pilot primary care-based distress screening program will be leveraged for this research, demonstrating the feasibility of this study. Implementation outcomes will be assessed with qualitative and survey data.
Knowledge gained from this research will be used to inform the continued development and implementation of systematic distress screening programs for breast cancer patients, and will enrich the evidence base by providing critical information on relevant patient- and system-level outcomes. These results will have an impact on the quality of life and quality of care for these patients, and will directly influence distress screening program adoption, scale-up, and spread, making this work highly relevant to breast cancer patients throughout California and across the nation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
Anaheim, California, United States, 92806
- Anaheim Medical Center
-
Baldwin Park, California, United States, 91706
- Baldwin Park Medical Center
-
Harbor City, California, United States, 90710
- South Bay - Harbor City Medical Center
-
Los Angeles, California, United States, 90027
- Los Angeles Medical Center
-
Los Angeles, California, United States, 90034
- West Los Angeles Medical Center
-
Woodland Hills, California, United States, 91364
- Woodland Hills Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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).
|
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.
|
Control
Newly diagnosed breast cancer patients will experience usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Offered and Screened for Distress
Time Frame: Patients assessed during initial consult - e.g. 1 day during 60 min consult
|
# 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
Time Frame: Patients assessed during initial consult - e.g. 1 day during 60 min consult
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
Time Frame: 12 months
|
Self-reported for physical well-being; social family well-being; emotional well-being; functional well-being; and additional concerns over the past 7 days; scale: 0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much; responses indicate symptoms/concerns in the past 7 days.
The higher the score, the better the outcome.
To derive a FACT-B total score, score range 0-148.
The subscales include: (1) Physical Well-Being, score range 0-28; (2) Social/Family Well-Being, score range 0-28; (3) Emotional Well-Being, score range 0-24; (4) Functional well-being, score range 0-28; (5) Breast Cancer Subscale, score range 0-40.
|
12 months
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
Time Frame: 12 months
|
Self-reported measure of physical symptoms in the past 4 weeks; scale: 0=not at all; 1=slightly; 2=moderately; 3=quite a bit; 4=extremely.
Higher scores indicate greater symptom burden.
Sub-scales include Hot Flashes, Nausea, Bladder Control, Vaginal Problems, Musculoskelatal Pain, Cognitive Problems, Weight Problems, and Arm Problems.
|
12 months
|
Number of Patients With Oncology Visit
Time Frame: 18 months
|
Between group comparison of number of visits to oncology.
Restricted to patients with at least 100 days of follow-up.
Covariates included in multivariable models were age, Charlson's comorbidity index, race/ethnicity, marital status, and cancer stage.
|
18 months
|
Number of Patients With Primary Care Visit
Time Frame: 18 months
|
Between group comparison of number of visits to primary care.
Restricted to patients with at least 100 days of follow-up.
Covariates included in multivariable models were age, Charlson's comorbidity index, race/ethnicity, marital status, and cancer stage.
|
18 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Utilizing Behavioral Health Services
Time Frame: 18 months
|
Between group comparison of number of visits with behavioral health providers.
Restricted to patients with at least 100 days of follow-up.
Covariates included in multivariable models were age, Charlson's comorbidity index, race/ethnicity, marital status, and cancer stage.
|
18 months
|
Number of Participants Utilizing Emergency and Urgent Care Services
Time Frame: 18 months
|
Between group comparison of number of visits to emergency and urgent care services.
Restricted to patients with at least 100 days of follow-up.
Covariates included in multivariable models were age, Charlson's comorbidity index, race/ethnicity, marital status, and cancer stage.
|
18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Erin E Hahn, PhD, Kaiser Permanente
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KPSC IRB 11103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
Clinical Trials on Distress screening
-
Case Comprehensive Cancer CenterTerminatedAdolescent and Young Adult CancerUnited States
-
The University of Hong KongHealth and Medical Research FundRecruiting
-
University Hospital, Basel, SwitzerlandRecruitingFrailty | Distress, EmotionalSwitzerland
-
Peking UniversityNot yet recruitingEmotional Disorder | Emotional DistressChina
-
Radboud University Medical CenterCompleted
-
Bozyaka Training and Research HospitalRecruiting
-
Centre Hospitalier Universitaire de BesanconCompletedHeart Arrest | Psychologic Stress
-
KU LeuvenZiekenhuis Oost-LimburgCompleted
-
Karabuk UniversityNot yet recruitingMenstruation Disturbances
-
Newcastle UniversityNewcastle-upon-Tyne Hospitals NHS Trust; Cumbria, Northumberland Tyne and Wear...Completed