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

Primary Purpose

End of Life, Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Receive technology-based supportive cancer care
Receive redesigned team-based supportive cancer care
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for End of Life focused on measuring 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

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • University of South Alabama
  • Beckman Research Institute of City of Hope
  • VA Medical Center, FresnoRecruiting
  • Santa Clara Valley Medical Center
  • St Jude Heritage Medical Group
  • Oncology Institute for Hope and Innovation
  • Sacramento VA Medical Center - VA Northern California Health Care SystemRecruiting
  • Pacific Cancer Care
  • VA Palo AltoRecruiting
  • Zuckerberg San Francisco General
  • Kaiser Foundation Research Institute
  • University of San Francisco
  • San Francisco VA Medical CenterRecruiting
  • Spark M. Matsunaga VA Medical CenterRecruiting
  • North Las Vegas VA Medical CenterRecruiting
  • George E. Wahlen Department of Veterans Affairs Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Technology-based supportive cancer care

Redesigned team-based supportive cancer care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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 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 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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 17, 2022
Last Updated
November 3, 2022
Sponsor
Stanford University
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05297734
Brief Title
Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer
Official Title
Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 24, 2022 (Actual)
Primary Completion Date
October 15, 2026 (Anticipated)
Study Completion Date
October 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster Randomized Controlled Trial among 24 clinics
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2996 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Technology-based supportive cancer care
Arm Type
Active Comparator
Arm Description
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 Title
Redesigned team-based supportive cancer care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Receive technology-based supportive cancer care
Other Intervention Name(s)
Technology-based SCC approach
Intervention Description
All participants will receive an electronic health record message or email with standardized information provided regarding advance care planning and symptom management.
Intervention Type
Behavioral
Intervention Name(s)
Receive redesigned team-based supportive cancer care
Other Intervention Name(s)
Patients Activated in Cancer care through Teams (PACT), Redesigned SCC team-based approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G).
Description
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 Outcome Measure Information:
Title
Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G).
Description
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
Title
Change in patient activation using the Patient Activation Measure (PAM-13).
Description
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
Title
Change in satisfaction with care using the Consumer Assessment of Health Care (Providers and Systems (CAHPS) Cancer Care Survey Questions #39 and #42.
Description
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
Title
Change in satisfaction with decision using the Satisfaction with Decision Scale (SWD)
Description
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
Title
Palliative Care Use (Self-reported and Chart Review)
Description
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
Title
Hospice Care Use (Self-reported and Chart Review)
Description
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
Title
Emergency Department Visits (Self-reported and Chart Review)
Description
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
Title
Hospitalization Visits (Self-reported and Chart Review)
Description
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
Title
Documentation of goals of care discussions (Chart Review)
Description
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
Title
Documentation of symptom discussions (Chart Review)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manali I Patel, MD MPH MS
Phone
6507234000
Email
manalip@stanford.edu
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabrielle Rocque, MD
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36688
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Y Pierce, MD
Facility Name
Beckman Research Institute of City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Finly Zachariah, MD
Phone
800-826-4673
Facility Name
VA Medical Center, Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93703
Country
United States
Individual Site Status
Recruiting
Facility Name
Santa Clara Valley Medical Center
City
Fruitdale
State/Province
California
ZIP/Postal Code
95128
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sangeeta Aggarwal, MD
Facility Name
St Jude Heritage Medical Group
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Park, MD
Facility Name
Oncology Institute for Hope and Innovation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richy Agajanian, MD
Facility Name
Sacramento VA Medical Center - VA Northern California Health Care System
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States
Individual Site Status
Recruiting
Facility Name
Pacific Cancer Care
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zach Koontz, MD
Facility Name
VA Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manali I Patel, MD MPH MS
First Name & Middle Initial & Last Name & Degree
Manali I Patel, MD MPH MS
Facility Name
Zuckerberg San Francisco General
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niharika Dixit, MD
Facility Name
Kaiser Foundation Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Liu, MD
Facility Name
University of San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Rhoads, MD
Facility Name
San Francisco VA Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Individual Site Status
Recruiting
Facility Name
Spark M. Matsunaga VA Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Individual Site Status
Recruiting
Facility Name
North Las Vegas VA Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89086
Country
United States
Individual Site Status
Recruiting
Facility Name
George E. Wahlen Department of Veterans Affairs Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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