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

Not Applicable

Recruiting

• Conditions: End of Life; Cancer
• Interventions: Behavioral: Receive redesigned team-based supportive cancer care; Other: Receive technology-based supportive cancer care

• Registration Number: NCT05297734
• Lead Sponsor: Stanford University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-28
• Study Start: 2022-06-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2028-01-31
• Study Completion: 2028-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2996

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Redesigned team-based supportive cancer care	Receive 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.
Technology-based supportive cancer care	Receive 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Documentation of symptom discussions (Chart Review)	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.
Palliative Care Use (Self-reported and Chart Review)	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.
Change in satisfaction with care using the Consumer Assessment of Health Care (Providers and Systems (CAHPS) Cancer Care Survey Questions #39 and #42.	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 health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G).	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 patient activation using the Patient Activation Measure (PAM-13).	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.
Hospice Care Use (Self-reported and Chart Review)	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.
Hospitalization Visits (Self-reported and Chart Review)	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.
Change in satisfaction with decision using the Satisfaction with Decision Scale (SWD)	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.
Emergency Department Visits (Self-reported and Chart Review)	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.
Documentation of goals of care discussions (Chart Review)	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.

Trial Locations

Locations (17)

University of South Alabama; 🇺🇸 Mobile, Alabama, United States

St Jude Heritage Medical Group; 🇺🇸 Fullerton, California, United States

North Las Vegas VA Medical Center; 🇺🇸 Las Vegas, Nevada, United States

Kaiser Foundation Research Institute; 🇺🇸 San Francisco, California, United States

University of San Francisco; 🇺🇸 San Francisco, California, United States

San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

VA Medical Center, Fresno; 🇺🇸 Fresno, California, United States

Beckman Research Institute of City of Hope; 🇺🇸 Duarte, California, United States

Oncology Institute for Hope and Innovation; 🇺🇸 Los Angeles, California, United States

Santa Clara Valley Medical Center; 🇺🇸 Fruitdale, California, United States

Sacramento VA Medical Center - VA Northern California Health Care System; 🇺🇸 Mather, California, United States

Pacific Cancer Care; 🇺🇸 Monterey, California, United States

VA Palo Alto; 🇺🇸 Palo Alto, California, United States

Zuckerberg San Francisco General; 🇺🇸 San Francisco, California, United States

George E. Wahlen Department of Veterans Affairs Medical Center; 🇺🇸 Salt Lake City, Utah, United States

Spark M. Matsunaga VA Medical Center; 🇺🇸 Honolulu, Hawaii, United States