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Implementing Systematic Distress Screening in Breast Cancer

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ClinicalTrials.gov Identifier: NCT02941614
Recruitment Status : Recruiting
First Posted : October 21, 2016
Last Update Posted : May 9, 2018
Sponsor:
Collaborator:
California Breast Cancer Research Program
Information provided by (Responsible Party):
Kaiser Permanente

Brief 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 such a large scale. Few studies have evaluated the impact of distress screening on important outcomes in breast cancer patients, such as patient experience, symptom management, and use of health care services, as compared to the usual care offered by the health care organization. In addition, oncology clinicians are 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) Is a community-oncology based, large-scale distress screening program more effective than usual care on improved identification of distressed patients, referral to behavioral health services, and patient-reported outcomes for breast cancer patients? 2) What are the barriers, facilitators, and other implementation-related outcomes related to distress screening in the community oncology setting?


Condition or disease Intervention/treatment
Breast Cancer Behavioral: Distress screening

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Implementing Systematic Distress Screening in Breast Cancer
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Distress screening
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).
Behavioral: Distress screening
A brief depression and anxiety screening instrument, the Patient Health Questionnaire (PHQ), will be administered to newly diagnosed breast cancer patients in the Distress Screening arm. The PHQ starts with a 2-item screen, and branches to the full screening instrument as needed.

No screening
Newly diagnosed breast cancer patients will experience usual care.



Primary Outcome Measures :
  1. Proportion screened for distress [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B) [ Time Frame: 18 months ]
  2. Breast Cancer Prevention Trial (BCPT) Symptom Checklist [ Time Frame: 18 months ]

Other Outcome Measures:
  1. Utilization of behavioral health services [ Time Frame: 24 months ]
    Between group comparison of number of visits with behavioral health providers

  2. Utilization of emergency and urgent care services [ Time Frame: 24 months ]
    Between group comparison of number of visits to emergency and urgent care services

  3. Organizational Readiness to Change Assessment [ Time Frame: 12 months ]
    Validated survey instrument which operationalizes the Consolidated Framework for Implementation Research (CFIR) domains for measurement



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed breast cancer patients
Criteria

Inclusion Criteria:

  • Newly diagnosed with initial breast cancer, any stage, any histology type
  • Kaiser Permanente member

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941614


Contacts
Contact: Erin E Hahn, PhD 626-564-3505 Erin.E.Hahn@kp.org
Contact: Corrine Munoz-Plaza, MPH 626-564-3094 Corrine.E.Munoz-Plaza@kp.org

Locations
United States, California
Anaheim Medical Center Recruiting
Anaheim, California, United States, 92806
Contact: Farah Brasfield, MD         
South Bay - Harbor City Medical Center Recruiting
Harbor City, California, United States, 90710
Contact: Lara Durna, MD         
Los Angeles Medical Center Recruiting
Los Angeles, California, United States, 90027
Contact: Karen Kwan, MD         
Sponsors and Collaborators
Kaiser Permanente
California Breast Cancer Research Program
Investigators
Principal Investigator: Erin E Hahn, PhD Kaiser Permanente

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02941614     History of Changes
Other Study ID Numbers: KPSC IRB 11103
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases