Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Receive technology-based supportive cancer care, Receive redesigned team-based supportive cancer care.
- Who it may be relevant to
- Registry conditions: End of Life, Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G). [Time frame: Change in health-related quality of life from baseline to 3 months]
Secondary outcome measures (10)
- Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G). [Time frame: Change in health-related quality of life from baseline to 6, and 12 months]
- Change in patient activation using the Patient Activation Measure (PAM-13). [Time frame: Change in patient activation from baseline to 3, 6, 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. [Time frame: Change in satisfaction with care from baseline to 3, 6, and 12 months]
- Change in satisfaction with decision using the Satisfaction with Decision Scale (SWD) [Time frame: Change in satisfaction with decision from baseline to 3, 6, and 12 months]
- Palliative Care Use (Self-reported and Chart Review) [Time frame: 3, 6, and 12 months after patient enrollment]
- Hospice Care Use (Self-reported and Chart Review) [Time frame: 3, 6, and 12 months after patient enrollment]
- Emergency Department Visits (Self-reported and Chart Review) [Time frame: 3, 6, and 12 months after patient enrollment]
- Hospitalization Visits (Self-reported and Chart Review) [Time frame: 3, 6, and 12 months after patient enrollment]
- Documentation of goals of care discussions (Chart Review) [Time frame: 3, 6, and 12 months after patient enrollment]
- Documentation of symptom discussions (Chart Review) [Time frame: 3, 6, and 12 months after patient enrollment]
Eligibility criteria
Inclusion criteria
- Newly diagnosed patients with solid tumor cancer diagnosis or recurrence of the disease.
- Patients must have the ability to understand and willingness to provide verbal consent.
- Participants must speak English, Spanish, Chinese, or Vietnamese.
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
United States · 17 centers
- University of Alabama at Birmingham — Birmingham
- University of South Alabama — Mobile
- Beckman Research Institute of City of Hope — Duarte
- VA Medical Center, Fresno — Fresno
- Santa Clara Valley Medical Center — Fruitdale
- St Jude Heritage Medical Group — Fullerton
- Oncology Institute for Hope and Innovation — Los Angeles
- Sacramento VA Medical Center - VA Northern California Health Care System — Mather
- … and 9 more centers
Identifiers
NCT: NCT05297734 · 63646