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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Stanford University
Study ID
NCT05297734
Status
Recruiting

Conditions

  • Cancer
  • End of Life

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Receive technology-based supportive cancer care — OTHER
    All participants will receive an electronic health record message or email with standardized information provided regarding advance care planning and symptom management.
  • Receive redesigned team-based supportive cancer care — BEHAVIORAL
    Lay Health Workers will meet with 1:1 with participants over 12 months to discuss advance care planning, surrogate decision-makers, advance directives and physician orders for life sustaining treatment.

Study Details

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.

Key Dates

Start date
Jun 24, 2022
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Feb 28, 2028

Study Design

Enrollment
2,996 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Technology-based supportive cancer care
    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.
  • Experimental: Redesigned team-based supportive cancer care
    Patients are paired with a health educator 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.

Primary Outcome Measure

Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G). [ Time Frame: Change in health-related quality of life from baseline to 3 months ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Gabrielle Rocque, MD
University of South AlabamaMobileAlabama36688
Jennifer Y Pierce, MD
Beckman Research Institute of City of HopeDuarteCalifornia91010
Finly Zachariah, MD
800-826-4673
VA Medical Center, FresnoFresnoCalifornia93703-
Santa Clara Valley Medical CenterFruitdaleCalifornia95128
Sangeeta Aggarwal, MD
St Jude Heritage Medical GroupFullertonCalifornia92835
David Park, MD
Oncology Institute for Hope and InnovationLos AngelesCalifornia90017
Richy Agajanian, MD
Sacramento VA Medical Center - VA Northern California Health Care SystemMatherCalifornia95655-
Pacific Cancer CareMontereyCalifornia93940-
VA Palo AltoPalo AltoCalifornia94305-
Kaiser Foundation Research InstituteSan FranciscoCalifornia94115
Raymond Liu, MD
San Francisco VA Medical CenterSan FranciscoCalifornia94121-
University of San FranciscoSan FranciscoCalifornia94117
Kim Rhoads, MD
Zuckerberg San Francisco GeneralSan FranciscoCalifornia94110
Niharika Dixit, MD
Spark M. Matsunaga VA Medical CenterHonoluluHawaii96819-
North Las Vegas VA Medical CenterLas VegasNevada89086-
George E. Wahlen Department of Veterans Affairs Medical CenterSalt Lake CityUtah84148-

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