CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,436 enrolled
Drug / intervention
Distress screeningbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02941614
NCT02941614N/ACompleted

Implementing Systematic Distress Screening in Breast Cancer

Kaiser Permanente·observational·Posted Oct 21, 2016·Updated Jul 7, 2020

In Brief

An observational study evaluating Distress screening for Breast Cancer. Completed, enrolled 1,436 participants across 6 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 21, 2016
Enrollment StartOct 2, 2017
Primary CompletionNov 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.7 years ago

Interventions

Distress screeningbehavioral

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.