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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Cluster Randomized Controlled Trial among 26 clinics
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Gabrielle Rocque, MD

More Details

Status
Recruiting
Sponsor
Stanford University

Study Contact

Manali I Patel, MD MPH MS
6507234000
manalip@stanford.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.