Breast Cancer Clinical Trial

Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer

Summary

This cluster-randomized comparative effectiveness trial compares a technology-based supportive cancer care (SCC) approach with a redesigned team-based supportive cancer care (SCC) approach.

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Full Description

PRIMARY OBJECTIVES:

I. Greater intervention effects on health-related quality of life

SECONDARY OBJECTIVES:

I. Greater intervention effects on patient activation II. Greater satisfaction with care and decision-making III. Greater documentation of goals of care and symptoms IV. To lower acute care V. Greater palliative care and hospice

OUTLINE: Sites are randomized to 1 of 2 arms.

ARM A: Patients receive educational materials to assist with advance care planning and symptom management through a technology-based supportive cancer care weekly during months 1-4 and every other week during months 5-12.

ARM B: Patients are paired with a lay health worker who will discuss the same educational materials from ARM A either in person or by telephone discussions weekly during months 1-4 and every other week during months 5-12.

All participants complete a baseline interview upon enrollment during the initial consent phone contact and then a survey at 3-, 6-and 12-months post enrollment.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Newly diagnosed patients with a solid tumor cancer diagnosis or hematologic malignancy
Patients must have the ability to understand and willingness to provide consent
Participants must speak English or Spanish

Exclusion Criteria:

Inability to consent to the study
Plans to change oncologist within 12 months
Employed by the practice site
Patients who anticipate moving from the area within 12 months

Study is for people with:

Breast Cancer

Estimated Enrollment:

2996

Study ID:

NCT05297734

Recruitment Status:

Recruiting

Sponsor:

Stanford University

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There are 17 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States More Info
Gabrielle Rocque, MD
Contact
University of South Alabama
Mobile Alabama, 36688, United States More Info
Jennifer Y Pierce, MD
Contact
Beckman Research Institute of City of Hope
Duarte California, 91010, United States More Info
Finly Zachariah, MD
Contact
800-826-4673
VA Medical Center, Fresno
Fresno California, 93703, United States
Santa Clara Valley Medical Center
Fruitdale California, 95128, United States More Info
Sangeeta Aggarwal, MD
Contact
St Jude Heritage Medical Group
Fullerton California, 92835, United States More Info
David Park, MD
Contact
Oncology Institute for Hope and Innovation
Los Angeles California, 90017, United States More Info
Richy Agajanian, MD
Contact
Sacramento VA Medical Center - VA Northern California Health Care System
Mather California, 95655, United States
Pacific Cancer Care
Monterey California, 93940, United States More Info
Zach Koontz, MD
Contact
VA Palo Alto
Palo Alto California, 94305, United States More Info
Manali I Patel, MD MPH MS
Contact
Manali I Patel, MD MPH MS
Principal Investigator
Zuckerberg San Francisco General
San Francisco California, 94110, United States More Info
Niharika Dixit, MD
Contact
Kaiser Foundation Research Institute
San Francisco California, 94115, United States More Info
Raymond Liu, MD
Contact
University of San Francisco
San Francisco California, 94117, United States More Info
Kim Rhoads, MD
Contact
San Francisco VA Medical Center
San Francisco California, 94121, United States
Spark M. Matsunaga VA Medical Center
Honolulu Hawaii, 96819, United States
North Las Vegas VA Medical Center
Las Vegas Nevada, 89086, United States
George E. Wahlen Department of Veterans Affairs Medical Center
Salt Lake City Utah, 84148, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

2996

Study ID:

NCT05297734

Recruitment Status:

Recruiting

Sponsor:


Stanford University

How clear is this clinincal trial information?

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