Implementing Systematic Distress Screening in Breast Cancer

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.

Inclusion Criteria:

- Newly diagnosed with initial breast cancer, any stage, any histology type

- Kaiser Permanente member

Exclusion Criteria: