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RecruitingInterventional

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

NCT ID: NCT05297734Sponsor: Stanford UniversityLast updated: 2026-04-30

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.

Detailed 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.

Arms & interventions

  • OtherReceive technology-based supportive cancer care

    All participants will receive an electronic health record message or email with standardized information provided regarding advance care planning and symptom management.

  • BehavioralReceive redesigned team-based supportive cancer care

    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.

Outcome measures

Primary

  • Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G).

    Each patient will receive a health-related quality of life survey (FACT-G) at baseline, 3 months, 6 months, and 12 months.

    Time frame: Change in health-related quality of life from baseline to 3 months

Secondary

  • 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 6, and 12 months

  • Change in patient activation using the Patient Activation Measure (PAM-13).

    Time frame: Change in patient activation from baseline to 3, 6, and 12 months

  • Change in satisfaction with care using the Consumer Assessment of Health Care (Providers and Systems (CAHPS) Cancer Care Survey Questions #39 and #42.

    Time frame: Change in satisfaction with care from baseline to 3, 6, and 12 months

  • Change in satisfaction with decision using the Satisfaction with Decision Scale (SWD)

    Time frame: Change in satisfaction with decision from baseline to 3, 6, and 12 months

  • Palliative Care Use (Self-reported and Chart Review)

    Time frame: 3, 6, and 12 months after patient enrollment

  • Hospice Care Use (Self-reported and Chart Review)

    Time frame: 3, 6, and 12 months after patient enrollment

  • Emergency Department Visits (Self-reported and Chart Review)

    Time frame: 3, 6, and 12 months after patient enrollment

  • Hospitalization Visits (Self-reported and Chart Review)

    Time frame: 3, 6, and 12 months after patient enrollment

  • Documentation of goals of care discussions (Chart Review)

    Time frame: 3, 6, and 12 months after patient enrollment

  • Documentation of symptom discussions (Chart Review)

    Time frame: 3, 6, and 12 months after patient enrollment

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: 1. Newly diagnosed patients with solid tumor cancer diagnosis or recurrence of the disease. 2. Patients must have the ability to understand and willingness to provide verbal consent. 3. Participants must speak English, Spanish, Chinese, or Vietnamese. Exclusion Criteria: 1. Inability to consent to the study 2. Plans to change oncologist within 12 months 3. Employed by the practice site 4. Patients who anticipate moving from the area within 12 months

Study locations (17)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

Recruiting
Gabrielle Rocque, MD · Contact

University of South Alabama

Mobile, Alabama, 36688

Recruiting
Jennifer Y Pierce, MD · Contact

Beckman Research Institute of City of Hope

Duarte, California, 91010

Recruiting
Finly Zachariah, MD · Contact

VA Medical Center, Fresno

Fresno, California, 93703

Recruiting

Santa Clara Valley Medical Center

Fruitdale, California, 95128

Recruiting
Sangeeta Aggarwal, MD · Contact

St Jude Heritage Medical Group

Fullerton, California, 92835

Recruiting
David Park, MD · Contact

Oncology Institute for Hope and Innovation

Los Angeles, California, 90017

Recruiting
Richy Agajanian, MD · Contact

Sacramento VA Medical Center - VA Northern California Health Care System

Mather, California, 95655

Active Not Recruiting

Pacific Cancer Care

Monterey, California, 93940

Active Not Recruiting

VA Palo Alto

Palo Alto, California, 94305

Active Not Recruiting

Zuckerberg San Francisco General

San Francisco, California, 94110

Recruiting
Niharika Dixit, MD · Contact

Kaiser Foundation Research Institute

San Francisco, California, 94115

Recruiting
Raymond Liu, MD · Contact

University of San Francisco

San Francisco, California, 94117

Recruiting
Kim Rhoads, MD · Contact

San Francisco VA Medical Center

San Francisco, California, 94121

Active Not Recruiting

Spark M. Matsunaga VA Medical Center

Honolulu, Hawaii, 96819

Recruiting

North Las Vegas VA Medical Center

Las Vegas, Nevada, 89086

Active Not Recruiting

George E. Wahlen Department of Veterans Affairs Medical Center

Salt Lake City, Utah, 84148

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