NCT02941614

Implementing Systematic Distress Screening in Breast Cancer

Completed Results posted Last updated 7 July 2020

What this trial tests

trial testing Distress screening in Breast Cancer in 1,436 participants. Completed in 30 November 2019.

Timeline

2 October 2017

Primary endpoint
30 November 2019

30 November 2019

Quick facts

Lead sponsor	Kaiser Permanente
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,436
Start date	2 October 2017
Primary completion	30 November 2019
Estimated completion	30 November 2019
Sites	6 locations across United States

Drugs / interventions tested

• Distress screening

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Kaiser Permanente — full company profile →

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Offered and Screened for Distress Primary · 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

Group	Value	95% CI
Distress Screening	596
No Screening	3

Number of Participants Offered an Appropriate Referral Primary · 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.

Group	Value	95% CI
Intervention	51
Control	0

Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B) Secondary · 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

Fact-B 3-month Total Score

Group	Value	95% CI
Distress Screening	104.5	± 22.1
No Screening	104.6	± 23.0

Fact-B 3-month Physical Well-Being Subscale

Group	Value	95% CI
Distress Screening	20.8	± 6.2
No Screening	20.5	± 6.5

Fact-B 3 month Social/Family Well-Being Subscale

Group	Value	95% CI
Distress Screening	21.2	± 6.2
No Screening	21.4	± 5.8

Fact-B 3 month Emotional Well-Being Subscale

Group	Value	95% CI
Distress Screening	18.3	± 4.3
No Screening	18.3	± 4.4

Fact-B 3-month Functional Well-Being Subscale

Group	Value	95% CI
Distress Screening	18.3	± 6.7
No Screening	18.1	± 6.6

Fact-B 3-month Breast Cancer Subscale

Group	Value	95% CI
Distress Screening	26.5	± 6.8
No Screening	26.4	± 6.9

Fact-B 6 month Total Score

Group	Value	95% CI
Distress Screening	108.1	± 22.3
No Screening	105.3	± 21.9

Fact-B 6 month Physical Well-Being Subscale

Group	Value	95% CI
Distress Screening	22.3	± 5.9
No Screening	21.9	± 5.4

Breast Cancer Prevention Trial (BCPT) Symptom Checklist Secondary · 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.

BCPT Survey 3 Month Total Score

Group	Value	95% CI
Distress Screening	0.9	± 0.6
No Screening	1.0	± 0.7

BCPT Survey 3 month Hot Flashes Sub-Scale

Group	Value	95% CI
Distress Screening	1.2	± 1.1
No Screening	1.2	± 1.2

BCPT Survey 3 month Nausea Sub-Scale

Group	Value	95% CI
Distress Screening	0.4	± 0.7
No Screening	0.5	± 0.8

BCPT Suvey 3 month Bladder Control Sub-Scale

Group	Value	95% CI
Distress Screening	0.6	± 0.9
No Screening	0.7	± 1.0

BCPT Survey 3 month Vaginal/Sex Problems Sub-Scale

Group	Value	95% CI
Distress Screening	0.6	± 1.0
No Screening	0.8	± 1.1

BCPT Survey 3 month Musculoskeletal Pain Sub-Scale

Group	Value	95% CI
Distress Screening	1.5	± 1.1
No Screening	1.5	± 1.1

BCPT Suvey 3 month Cognitive Problems Sub-Scale

Group	Value	95% CI
Distress Screening	1.2	± 1.0
No Screening	1.2	± 1.1

BCPT Survey 3 month Weight Problems Sub-Scale

Group	Value	95% CI
Distress Screening	1.1	± 1.0
No Screening	1.2	± 1.2

Number of Patients With Oncology Visit Secondary · 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.

Group	Value	95% CI
Distress Screening	728
No Screening	683

Number of Patients With Primary Care Visit Secondary · 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.

Group	Value	95% CI
Distress Screening	648
No Screening	616

Number of Participants Utilizing Behavioral Health Services Secondary · 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.

Group	Value	95% CI
Distress Screening	287
No Screening	247

Number of Participants Utilizing Emergency and Urgent Care Services Secondary · 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.

ED Visits

Group	Value	95% CI
Distress Screening	248
No Screening	213

Urgent Care Visits

Group	Value	95% CI
Distress Screening	269
No Screening	279

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of a Community-Based Medical Oncology Depression Screening Program on Behavioral Health Referrals Among Patients With Breast Cancer: A Randomized Clinical Trial.
   Hahn EE, Munoz-Plaza CE, Pounds D, Lyons LJ, et al · · 2022 · cited 22× · PMID 34982119 · DOI 10.1001/jama.2021.22596
2. Barriers and facilitators to implementation and sustainment of guideline-recommended depression screening for patients with breast cancer in medical oncology: a qualitative study.
   Hahn EE, Munoz-Plaza CE, Lyons LJ, Lee JS, et al · · 2023 · cited 2× · PMID 37436477 · DOI 10.1007/s00520-023-07922-0