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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05297734
• Other study ID #: 63646
• Status: Recruiting
• Phase: N/A
• Start date: June 24, 2022
• Est. completion date: February 28, 2028

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: Manali I Patel, MD MPH MS
• Phone: 6507234000
• Email: manalip[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2996
• Est. completion date: February 28, 2028
• Est. primary completion date: January 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Newly diagnosed patients with a solid tumor cancer diagnosis or hematologic malignancy

2. Patients must have the ability to understand and willingness to provide consent

3. Participants must speak English or Spanish

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

Related Conditions & MeSH terms

• Cancer
• Death
• End of Life

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beckman Research Institute of City of Hope	Duarte	California
United States	VA Medical Center, Fresno	Fresno	California
United States	Santa Clara Valley Medical Center	Fruitdale	California
United States	St Jude Heritage Medical Group	Fullerton	California
United States	Spark M. Matsunaga VA Medical Center	Honolulu	Hawaii
United States	North Las Vegas VA Medical Center	Las Vegas	Nevada
United States	Oncology Institute for Hope and Innovation	Los Angeles	California
United States	Sacramento VA Medical Center - VA Northern California Health Care System	Mather	California
United States	University of South Alabama	Mobile	Alabama
United States	Pacific Cancer Care	Monterey	California
United States	VA Palo Alto	Palo Alto	California
United States	George E. Wahlen Department of Veterans Affairs Medical Center	Salt Lake City	Utah
United States	Kaiser Foundation Research Institute	San Francisco	California
United States	San Francisco VA Medical Center	San Francisco	California
United States	University of San Francisco	San Francisco	California
United States	Zuckerberg San Francisco General	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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).	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
Secondary	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.	Change in patient activation from baseline to 3, 6, and 12 months
Secondary	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.	Change in satisfaction with care from baseline to 3, 6, and 12 months
Secondary	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.	Change in satisfaction with decision from baseline to 3, 6, and 12 months
Secondary	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.	3, 6, and 12 months after patient enrollment
Secondary	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.	3, 6, and 12 months after patient enrollment
Secondary	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.	3, 6, and 12 months after patient enrollment
Secondary	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.	3, 6, and 12 months after patient enrollment
Secondary	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.	3, 6, and 12 months after patient enrollment
Secondary	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.	3, 6, and 12 months after patient enrollment