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

Sponsor

Stanford University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05297734

Collaborator

Patient-Centered Outcomes Research Institute (Other)

2,996

Enrollment

Locations

Arms

51.7

Anticipated Duration (Months)

176.2

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End of Life Cancer	Other: Receive technology-based supportive cancer care Behavioral: Receive redesigned team-based supportive cancer care	N/A

Detailed Description

PRIMARY OBJECTIVES:

Greater intervention effects on health-related quality of life

SECONDARY OBJECTIVES:

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 Design

Study Type:

Interventional

Anticipated Enrollment :

2996 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Cluster Randomized Controlled Trial among 24 clinicsCluster Randomized Controlled Trial among 24 clinics

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Jun 24, 2022

Anticipated Primary Completion Date :

Oct 15, 2026

Anticipated Study Completion Date :

Oct 15, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.
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 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.
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.
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.
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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Newly diagnosed patients with a solid tumor cancer diagnosis or hematologic malignancy
Patients must have the ability to understand and willingness to provide consent
Participants must speak English or Spanish

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	University of South Alabama	Mobile	Alabama	United States	36688
3	Beckman Research Institute of City of Hope	Duarte	California	United States	91010
4	VA Medical Center, Fresno	Fresno	California	United States	93703
5	Santa Clara Valley Medical Center	Fruitdale	California	United States	95128
6	St Jude Heritage Medical Group	Fullerton	California	United States	92835
7	Oncology Institute for Hope and Innovation	Los Angeles	California	United States	90017
8	Sacramento VA Medical Center - VA Northern California Health Care System	Mather	California	United States	95655
9	Pacific Cancer Care	Monterey	California	United States	93940
10	VA Palo Alto	Palo Alto	California	United States	94305
11	Zuckerberg San Francisco General	San Francisco	California	United States	94110
12	Kaiser Foundation Research Institute	San Francisco	California	United States	94115
13	University of San Francisco	San Francisco	California	United States	94117
14	San Francisco VA Medical Center	San Francisco	California	United States	94121
15	Spark M. Matsunaga VA Medical Center	Honolulu	Hawaii	United States	96819
16	North Las Vegas VA Medical Center	Las Vegas	Nevada	United States	89086
17	George E. Wahlen Department of Veterans Affairs Medical Center	Salt Lake City	Utah	United States	84148