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

April 24, 2026 updated by: Manali Indravadan Patel, Stanford University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

2996

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
          • Gabrielle Rocque, MD
      • Mobile, Alabama, United States, 36688
        • Recruiting
        • University of South Alabama
        • Contact:
          • Jennifer Y Pierce, MD
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • Beckman Research Institute of City of Hope
        • Contact:
          • Finly Zachariah, MD
          • Phone Number: 800-826-4673
      • Fresno, California, United States, 93703
        • Recruiting
        • VA Medical Center, Fresno
      • Fruitdale, California, United States, 95128
        • Recruiting
        • Santa Clara Valley Medical Center
        • Contact:
          • Sangeeta Aggarwal, MD
      • Fullerton, California, United States, 92835
        • Recruiting
        • St Jude Heritage Medical Group
        • Contact:
          • David Park, MD
      • Los Angeles, California, United States, 90017
        • Recruiting
        • Oncology Institute for Hope and Innovation
        • Contact:
          • Richy Agajanian, MD
      • Mather, California, United States, 95655
        • Active, not recruiting
        • Sacramento VA Medical Center - VA Northern California Health Care System
      • Monterey, California, United States, 93940
        • Active, not recruiting
        • Pacific Cancer Care
      • Palo Alto, California, United States, 94305
        • Active, not recruiting
        • VA Palo Alto
      • San Francisco, California, United States, 94110
        • Recruiting
        • Zuckerberg San Francisco General
        • Contact:
          • Niharika Dixit, MD
      • San Francisco, California, United States, 94121
        • Active, not recruiting
        • San Francisco VA Medical Center
      • San Francisco, California, United States, 94115
        • Recruiting
        • Kaiser Foundation Research Institute
        • Contact:
          • Raymond Liu, MD
      • San Francisco, California, United States, 94117
        • Recruiting
        • University of San Francisco
        • Contact:
          • Kim Rhoads, MD
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Recruiting
        • Spark M. Matsunaga VA Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89086
        • Active, not recruiting
        • North Las Vegas VA Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • Recruiting
        • George E. Wahlen Department of Veterans Affairs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Receive 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.
Other Names:
  • Technology-based SCC approach
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.
Behavioral: Receive 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.
Other Names:
  • Patients Activated in Cancer care through Teams (PACT), Redesigned SCC team-based approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Each patient will receive a health-related quality of life survey (FACT-G) at baseline, 3 months, 6 months, and 12 months.
Change in health-related quality of life from baseline to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Each patient will receive a health-related quality of life survey (FACT-G) at baseline, 3 months, 6 months, and 12 months.
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
Each patient will receive a validated patient activation survey (PAM-13) to assess their activation at baseline, 3 months, 6 months, and 12 months.
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
Each patient will receive a validated satisfaction with care survey at baseline, 3 months, 6 months, and 12 months.
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
Each patient will receive a validated satisfaction with decision survey at baseline, 3 months, 6 months and 12 months.
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
Palliative care use will be self-reported by each patient or abstracted by electronic medical record at 3, 6 and 12 months after patient enrollment.
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
Hospice care use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, and 12 months after patient enrollment.
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
Emergency Department use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, and 12 months after enrollment.
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
Hospital use for each patient will be self-reported by each patient or abstracted by electronic medical record at 3, 6, and 12 months after enrollment.
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 goals of care discussions will be abstracted by electronic medical record chart review for each patient at 3, 6, and 12 months after enrollment.
3, 6, and 12 months after patient enrollment
Documentation of symptom discussions (Chart Review)
Time Frame: 3, 6, and 12 months after patient enrollment
Documentation of symptom discussions will be abstracted by electronic medical record chart review for each patient at 3, 6, and 12 months after enrollment.
3, 6, and 12 months after patient enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Toxicity
Time Frame: 3, 6, and 12 months after patient enrollment
Each patient will receive a time toxicity survey at baseline, 3 months, 6 months and 12 months.
3, 6, and 12 months after patient enrollment
Financial Toxicity
Time Frame: 3, 6, and 12 months after patient enrollment
Each patient will receive the validated COmprehensive Score for financial Toxicity (COST)-Functional Assessment of Chronic Illness Therapy (COST-FACIT) questionnaire at baseline, 3 months, 6 months, and 12 months.
3, 6, and 12 months after patient enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Patient-Centered Outcomes Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2022

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

February 28, 2028

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 63646

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on Receive technology-based supportive cancer care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe