Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer
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
- End of Life
- Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Arm | Description | Assigned 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. |
|
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. |
|
Recruiting Locations
Birmingham, Alabama 35294
Gabrielle Rocque, MD
More Details
- Status
- Recruiting
- Sponsor
- Stanford University
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.