Clinical trial NCT05297734: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2022-03-28
Enrollment: 2996
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized Controlled Trial among 26 clinics
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

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

Primary outcomes:
measure: Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G).
timeFrame: Change in health-related quality of life from baseline to 3 months
Secondary outcomes:
measure: Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G).
timeFrame: Change in health-related quality of life from baseline to 6, and 12 months
measure: Change in patient activation using the Patient Activation Measure (PAM-13).
timeFrame: Change in patient activation from baseline to 3, 6, and 12 months
measure: Change in satisfaction with care using the Consumer Assessment of Health Care (Providers and Systems (CAHPS) Cancer Care Survey Questions #39 and #42.
timeFrame: Change in satisfaction with care from baseline to 3, 6, and 12 months
measure: Change in satisfaction with decision using the Satisfaction with Decision Scale (SWD)
timeFrame: Change in satisfaction with decision from baseline to 3, 6, and 12 months
measure: Palliative Care Use (Self-reported and Chart Review)
timeFrame: 3, 6, and 12 months after patient enrollment
measure: Hospice Care Use (Self-reported and Chart Review)
timeFrame: 3, 6, and 12 months after patient enrollment
measure: Emergency Department Visits (Self-reported and Chart Review)
timeFrame: 3, 6, and 12 months after patient enrollment
measure: Hospitalization Visits (Self-reported and Chart Review)
timeFrame: 3, 6, and 12 months after patient enrollment
measure: Documentation of goals of care discussions (Chart Review)
timeFrame: 3, 6, and 12 months after patient enrollment
measure: Documentation of symptom discussions (Chart Review)
timeFrame: 3, 6, and 12 months after patient enrollment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Duarte
country: United States
facility: Beckman Research Institute of City of Hope
state: California
city: Fresno
country: United States
facility: VA Medical Center, Fresno
state: California
city: Fruitdale
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Fullerton
country: United States
facility: St Jude Heritage Medical Group
state: California
city: Los Angeles
country: United States
facility: Oncology Institute for Hope and Innovation
state: California
city: Mather
country: United States
facility: Sacramento VA Medical Center - VA Northern California Health Care System
state: California
city: Monterey
country: United States
facility: Pacific Cancer Care
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto
state: California
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General
state: California
city: San Francisco
country: United States
facility: Kaiser Foundation Research Institute
state: California
city: San Francisco
country: United States
facility: University of San Francisco
state: California
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
city: Honolulu
country: United States
facility: Spark M. Matsunaga VA Medical Center
state: Hawaii
city: Las Vegas
country: United States
facility: North Las Vegas VA Medical Center
state: Nevada
city: Salt Lake City
country: United States
facility: George E. Wahlen Department of Veterans Affairs Medical Center
state: Utah
Study officials:
References: