NCT Number: NCT05297734
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
University of Alabama at Birmingham, Birmingham, Alabama, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3, 6, and 12 months after patient enrollment
Each patient will receive a time toxicity survey at baseline, 3 months, 6 months and 12 months.
Time frame: 3, 6, and 12 months after patient enrollment
Each patient will receive the validated COmprehensive Score for financial Toxicity (COST)-Functional Assessment of Chronic Illness Therapy (COST-FACIT) questionnaire at baseline, 3 months, 6 months, and 12 months.
Contact information is provided by the study sponsor or research team.
Stanford University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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