Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making

Breast Cancer Stage II Clinical Trial

Official title:

Increasing Socioeconomically Disadvantaged Patients' Engagement in Breast Cancer Surgery Decision Making Through a Shared Decision Making Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03766009
• Other study ID #: A231701CD
• Secondary ID: NCI-2018-00643
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 15, 2023

Study information

• Verified date: February 2023
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial studies how well a breast cancer surgery decision aid works in increasing patient engagement in decision making for patients with newly diagnosed stage 0-III breast cancer. The trial also examines barriers to patient engagement even with the use of a decision aid, and if barriers are more likely to be experienced by socioeconomically disadvantaged patients.

Description:

The primary and secondary objectives of the study:

PRIMARY OBJECTIVES:

I. Test the effectiveness of a breast cancer surgery decision aid in increasing patient engagement in decision making (measured by knowledge and power) in clinics serving a high proportion of socioeconomically disadvantaged patients.

II. Test the extent to which the effect of a decision aid on patient engagement is mediated through the mitigation of barriers and determine if persistent barriers are disproportionately experienced by socioeconomically disadvantaged patients.

SECONDARY OBJECTIVES:

I. Characterize how persistent barriers influence patient engagement in decision making in order to identify targets for adjunct interventions that could be implemented in clinics serving a high proportion of socioeconomically disadvantaged patients.

Trial Design:

OUTLINE: This is a multi-site cluster randomized trial using a stepped wedge design. Ten clinics will be recruited for participation. All clinics will begin in the usual care arm. Clinics will be randomized to the timing with which they cross-over to the decision aid intervention, with new clinics crossing over every 10 weeks.

ARM I: usual care

ARM II: decision aid intervention

The only difference between patients enrolled before institutional crossover and patients enrolled after institutional crossover is those who are enrolled after institutional crossover will have been offered the decision aid as accepted practice in the clinic.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 598
• Est. completion date: December 15, 2023
• Est. primary completion date: January 26, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Newly diagnosed with stage 0-III breast cancer

• Eligible patients must be planning breast surgery as a component of their definitive treatment

• Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study

• Patients with hearing impairment requiring the use of an interpreter are not eligible for this study

• Patients must be able to speak English with the fluency required to have a direct discussion around treatment decision-making (i.e. without interpreter)

• CLINIC STAKEHOLDER (SURGEONS AND CLINIC STAFF): Breast surgeon(s) and nursing staff, medical assistant, or mid-level provider at each participating clinic who participates in the care of patients newly diagnosed with breast cancer

• INSTITUTIONAL: 10 clinics that annually provide surgical care for 120-300 patients newly diagnosed with breast cancer will be selected to participate in this study

• INSTITUTIONAL: Surgeons at eligible clinics must consent to the study as a requirement for site participation

Related Conditions & MeSH terms

• Breast Cancer Stage 0
• Breast Cancer Stage I
• Breast Cancer Stage II
• Breast Cancer Stage III
• Breast Carcinoma In Situ
• Breast Neoplasms

Intervention

Other:
• Usual Care
Usual Care
• Web-based decision aid
Web-based decision aid received prior to the surgical consultation

Locations

Country	Name	City	State
Guam	FHP Health Center-Guam	Tamuning
Puerto Rico	Pan American Center for Oncology Trials LLC	San Juan
United States	Hawaii Cancer Care - Savio	'Aiea	Hawaii
United States	Pali Momi Medical Center	'Aiea	Hawaii
United States	Queen's Cancer Center - Pearlridge	'Aiea	Hawaii
United States	The Cancer Center of Hawaii-Pali Momi	'Aiea	Hawaii
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Community Hospital of Anaconda	Anaconda	Montana
United States	Augusta University Medical Center	Augusta	Georgia
United States	Saint Alphonsus Medical Center-Baker City	Baker City	Oregon
United States	Billings Clinic Cancer Center	Billings	Montana
United States	Saint Alphonsus Cancer Care Center-Boise	Boise	Idaho
United States	Bozeman Deaconess Hospital	Bozeman	Montana
United States	Saint Alphonsus Cancer Care Center-Caldwell	Caldwell	Idaho
United States	Medical University of South Carolina	Charleston	South Carolina
United States	John H Stroger Jr Hospital of Cook County	Chicago	Illinois
United States	Billings Clinic-Cody	Cody	Wyoming
United States	Kootenai Health - Coeur d'Alene	Coeur d'Alene	Idaho
United States	Carle on Vermilion	Danville	Illinois
United States	Epic Care-Dublin	Dublin	California
United States	Carle Physician Group-Effingham	Effingham	Illinois
United States	Bay Area Breast Surgeons Inc	Emeryville	California
United States	Epic Care Partners in Cancer Care	Emeryville	California
United States	Walter Knox Memorial Hospital	Emmett	Idaho
United States	Benefis Healthcare- Sletten Cancer Institute	Great Falls	Montana
United States	Great Falls Clinic	Great Falls	Montana
United States	Saint Peter's Community Hospital	Helena	Montana
United States	Hawaii Cancer Care Inc - Waterfront Plaza	Honolulu	Hawaii
United States	Hawaii Cancer Care Inc-Liliha	Honolulu	Hawaii
United States	Island Urology	Honolulu	Hawaii
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	Kuakini Medical Center	Honolulu	Hawaii
United States	Queen's Cancer Cenrer - POB I	Honolulu	Hawaii
United States	Queen's Cancer Center - Kuakini	Honolulu	Hawaii
United States	Queen's Medical Center	Honolulu	Hawaii
United States	Straub Clinic and Hospital	Honolulu	Hawaii
United States	The Cancer Center of Hawaii-Liliha	Honolulu	Hawaii
United States	University of Hawaii Cancer Center	Honolulu	Hawaii
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Wilcox Memorial Hospital and Kauai Medical Clinic	Lihue	Hawaii
United States	Marshfield Medical Center-Marshfield	Marshfield	Wisconsin
United States	Contra Costa Regional Medical Center	Martinez	California
United States	Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois
United States	Idaho Urologic Institute-Meridian	Meridian	Idaho
United States	Community Medical Hospital	Missoula	Montana
United States	Saint Alphonsus Medical Center-Nampa	Nampa	Idaho
United States	Ochsner Medical Center Jefferson	New Orleans	Louisiana
United States	Alta Bates Summit Medical Center - Summit Campus	Oakland	California
United States	Bay Area Tumor Institute	Oakland	California
United States	Saint Alphonsus Medical Center-Ontario	Ontario	Oregon
United States	Kootenai Clinic Cancer Services - Post Falls	Post Falls	Idaho
United States	VCU Massey Cancer Center at Stony Point	Richmond	Virginia
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia
United States	Kootenai Cancer Clinic	Sandpoint	Idaho
United States	Welch Cancer Center	Sheridan	Wyoming
United States	Carle Cancer Center	Urbana	Illinois
United States	The Carle Foundation Hospital	Urbana	Illinois
United States	Epic Care Cyberknife Center	Walnut Creek	California

Sponsors (3)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	Agency for Healthcare Research and Quality (AHRQ), National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Guam,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient power: self-efficacy in patient physician interactions	Power is defined as patients' self-perceived capacity to influence the decision-making encounter. This construct is measured using the Patient's Self-Efficacy in Patient-Physician Interactions (PEPPI)-5 point scale; the primary outcome measure is a total score ranging from 5-25, where higher scores indicate increased self-efficacy. The patient completes the PEPPI-5 questionnaire within 3 weeks post-surgical consultation.	Up to 3 weeks
Primary	Patient power: active patient participation	Power is also separately measured by the validated Active Patient Participation Behaviors System to assess active patient participation during the surgeon consultation and is measured off the audio-recording of the consultation; a summary measure of patient's active involvement in the interaction is coded by a third party and represents a count of patients' communicative behaviors ranging from 0-99, where higher scores indicate increased active patient participation. The consultation for a patient will typically be study day 1 (day of registration).	1 day
Secondary	Patient knowledge	Patient knowledge is measured from 5 knowledge questions in the Decision Quality Instrument-Breast Surgery survey, with a percent correct recorded as the secondary outcome measure, ranging from 0-100%. The patient completes the Decision Quality Instrument-Breast Surgery survey within 3 weeks post-surgical consultation.	Up to 3 weeks
Secondary	Concordance between personal values and surgery received	This is a binary outcome reflecting whether surgery received (mastectomy; lumpectomy) was concordant or not with the patient's personal values. The patient's personal values are measured from 3 questions on the Decision Quality Instrument (DQI)-Breast Surgery survey; each question ranges from 0 (not at all important) to 10 (extremely important). . The patient completes the DQI within 3 weeks post-consultation. The method by Sepucha et al (2012) will be applied to determine concordance between personal values and surgery received.	Up to 3 weeks