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End of LifeNCT05297734

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

A study testing Receive technology-based supportive cancer care and Receive redesigned team-based supportive cancer care in people with End of Life and Cancer, run by Stanford University at 17 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End of Life, Cancer
What is being tested?
Receive technology-based supportive cancer care and Receive redesigned team-based supportive cancer care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,996 participants
Where
17 sitesUnited States
Study dates
24 Jun 2022to 28 Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed patients with solid tumor cancer diagnosis or recurrence of the disease.
  • Patients must have the ability to understand and willingness to provide verbal consent.
  • Participants must speak English, Spanish, Chinese, or Vietnamese.

Who cannot join

  • 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

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Manali I Patel, MD MPH MS contact

6507234000

manalip@stanford.edu

17 sites in 1 country

United States17 sites, 12 recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Gabrielle Rocque, MD

    Recruiting

  • Beckman Research Institute of City of Hope

    Duarte, California, 91010

    Finly Zachariah, MD, 800-826-4673

    Recruiting

  • VA Medical Center, Fresno

    Fresno, California, 93703

    Recruiting

  • Santa Clara Valley Medical Center

    Fruitdale, California, 95128

    Sangeeta Aggarwal, MD

    Recruiting

  • St Jude Heritage Medical Group

    Fullerton, California, 92835

    David Park, MD

    Recruiting

  • Spark M. Matsunaga VA Medical Center

    Honolulu, Hawaii, 96819

    Recruiting

  • North Las Vegas VA Medical Center

    Las Vegas, Nevada, 89086

    Active, not recruiting

  • Oncology Institute for Hope and Innovation

    Los Angeles, California, 90017

    Richy Agajanian, MD

    Recruiting

  • Sacramento VA Medical Center - VA Northern California Health Care System

    Mather, California, 95655

    Active, not recruiting

  • University of South Alabama

    Mobile, Alabama, 36688

    Jennifer Y Pierce, MD

    Recruiting

  • Pacific Cancer Care

    Monterey, California, 93940

    Active, not recruiting

  • VA Palo Alto

    Palo Alto, California, 94305

    Active, not recruiting

  • George E. Wahlen Department of Veterans Affairs Medical Center

    Salt Lake City, Utah, 84148

    Recruiting

  • Zuckerberg San Francisco General

    San Francisco, California, 94110

    Niharika Dixit, MD

    Recruiting

  • Kaiser Foundation Research Institute

    San Francisco, California, 94115

    Raymond Liu, MD

    Recruiting

  • University of San Francisco

    San Francisco, California, 94117

    Kim Rhoads, MD

    Recruiting

  • San Francisco VA Medical Center

    San Francisco, California, 94121

    Active, not recruiting

Other trials in United States

About this study

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:

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

SECONDARY OBJECTIVES:

  1. 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.

Conditions
End of Life, Cancer
Being tested
Receive technology-based supportive cancer care, Receive redesigned team-based supportive cancer care
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
Medical subject headings
Death, Neoplasms, Carcinoma, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Melanoma, Pancreatic Neoplasms, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Receive technology-based supportive cancer careOther

    Also called Technology-based SCC approach

    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 careBehavioural

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

    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 groups in NCT05297734
Study groupRoleWhat they receive
Technology-based supportive cancer careActive comparatorPatients 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.
Receives: Other: Receive technology-based supportive cancer care
Redesigned team-based supportive cancer careExperimentalPatients 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.
Receives: Behavioral: Receive redesigned team-based supportive cancer care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (10)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 3, 6, and 12 months after patient enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2022
  2. Study start24 Jun 2022
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion28 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster Randomized Controlled Trial among 26 clinics
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,996 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05297734
Sponsor's protocol ID
63646
Status last verified
Apr 2026
First submitted
17 Mar 2022
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Receive technology-based supportive cancer care and Receive redesigned team-based supportive cancer care in people with End of Life and Cancer, run by Stanford University at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Manali I Patel, MD MPH MS (6507234000, manalip@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05297734.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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