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RecruitingNCT05297734Updated Apr 30, 2026

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

An interventional study of Receive technology-based supportive cancer care and Receive redesigned team-based supportive cancer care in End of Life and Cancer, sponsored by Stanford University. Recruiting at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by Stanford University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
2,996
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • End of Life
  • Cancer

Keywords

  • Carcinoma
  • Lung Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Melanoma
  • Pancreatic Neoplasms
  • Sarcoma
  • Ovarian Neoplasms
  • Carcinoma, Ovarian Epithelial
  • Stomach Neoplasms
  • Glioblastoma
  • Rectal Neoplasms
  • Colonic Neoplasms
  • Esophageal Neoplasms
  • Breast Neoplasms
  • Carcinoma, Renal Cell
  • Skin Neoplasms
  • Small Cell Lung Carcinoma
  • Osteosarcoma
  • Myelodysplastic Syndromes
  • Disease Progression
  • Neoplasms, Glandular and Epithelial
  • Neoplasms by Histologic Type
  • Neoplasms
  • Respiratory Tract Neoplasms
  • Thoracic Neoplasms
  • Neoplasms by Site
  • Lung Diseases
  • Respiratory Tract Diseases
  • Urogenital Neoplasms
  • Carcinoma, Bronchogenic
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy 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

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
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
2,996 participants (estimated)

Study 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.

    Other: Receive technology-based supportive cancer care

  • 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

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.

    Also known as: Technology-based SCC approach

  • 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.

    Also known as: Patients Activated in Cancer care through Teams (PACT), Redesigned SCC team-based approach

05

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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 6, and 12 months

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

    Each patient will receive a validated patient activation survey (PAM-13) to assess their activation at baseline, 3 months, 6 months, and 12 months.

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

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

    Each patient will receive a validated satisfaction with care survey at baseline, 3 months, 6 months, and 12 months.

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

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

    Each patient will receive a validated satisfaction with decision survey at baseline, 3 months, 6 months and 12 months.

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

  5. Palliative Care Use (Self-reported and Chart Review)

    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.

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

  6. Hospice Care Use (Self-reported and Chart Review)

    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.

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

  7. Emergency Department Visits (Self-reported and Chart Review)

    Emergency Department use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, and 12 months after enrollment.

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

  8. Hospitalization Visits (Self-reported and Chart Review)

    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.

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

  9. Documentation of goals of care discussions (Chart Review)

    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.

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

  10. Documentation of symptom discussions (Chart Review)

    Documentation of symptom discussions will be abstracted by electronic medical record chart review for each patient at 3, 6, and 12 months after enrollment.

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

Other outcomes

  1. Time Toxicity

    Each patient will receive a time toxicity survey at baseline, 3 months, 6 months and 12 months.

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

  2. Financial Toxicity

    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.

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

06

Study locations

12 of 17 sites recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
    • Gabrielle Rocque, MD · Contact
    Recruiting
  • University of South Alabama
    Mobile, Alabama 36688, United States
    • Jennifer Y Pierce, MD · Contact
    Recruiting
  • Beckman Research Institute of City of Hope
    Duarte, California 91010, United States
    • Finly Zachariah, MD · Contact · 800-826-4673
    Recruiting
  • VA Medical Center, Fresno
    Fresno, California 93703, United States
    Recruiting
  • Santa Clara Valley Medical Center
    Fruitdale, California 95128, United States
    • Sangeeta Aggarwal, MD · Contact
    Recruiting
  • St Jude Heritage Medical Group
    Fullerton, California 92835, United States
    • David Park, MD · Contact
    Recruiting
  • Oncology Institute for Hope and Innovation
    Los Angeles, California 90017, United States
    • Richy Agajanian, MD · Contact
    Recruiting
  • Sacramento VA Medical Center - VA Northern California Health Care System
    Mather, California 95655, United States
    Active, not recruiting
  • Pacific Cancer Care
    Monterey, California 93940, United States
    Active, not recruiting
  • VA Palo Alto
    Palo Alto, California 94305, United States
    Active, not recruiting
  • Zuckerberg San Francisco General
    San Francisco, California 94110, United States
    • Niharika Dixit, MD · Contact
    Recruiting
  • Kaiser Foundation Research Institute
    San Francisco, California 94115, United States
    • Raymond Liu, MD · Contact
    Recruiting
  • University of San Francisco
    San Francisco, California 94117, United States
    • Kim Rhoads, MD · Contact
    Recruiting
  • San Francisco VA Medical Center
    San Francisco, California 94121, United States
    Active, not recruiting
  • Spark M. Matsunaga VA Medical Center
    Honolulu, Hawaii 96819, United States
    Recruiting
  • North Las Vegas VA Medical Center
    Las Vegas, Nevada 89086, United States
    Active, not recruiting
  • George E. Wahlen Department of Veterans Affairs Medical Center
    Salt Lake City, Utah 84148, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT05297734
Lead sponsor
Stanford University
Collaborators
Patient-Centered Outcomes Research Institute
Responsible party
Manali Indravadan Patel (Assistant Professor of Medicine, Stanford University) — Principal investigator
First posted
Mar 28, 2022
Start date
Jun 24, 2022
Primary completion
Jan 31, 2028 (estimated)
Completion
Feb 28, 2028 (estimated)
Last update
Apr 30, 2026

Study contacts

Manali I Patel, MD MPH MS
Contact
manalip@stanford.edu
6507234000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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