Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- End of Life
- Sponsor
- Stanford University
- Enrollment
- 2996
- Locations
- 17
- Primary Endpoint
- Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G).
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Manali Indravadan Patel
Assistant Professor of Medicine
Stanford University
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
Outcomes
Primary Outcomes
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
Each patient will receive a health-related quality of life survey (FACT-G) at baseline, 3 months, 6 months, and 12 months.
Secondary Outcomes
- Documentation of symptom discussions (Chart Review)(3, 6, and 12 months after patient enrollment)
- Palliative Care Use (Self-reported and Chart Review)(3, 6, and 12 months after patient enrollment)
- Change in satisfaction with care using the Consumer Assessment of Health Care (Providers and Systems (CAHPS) Cancer Care Survey Questions #39 and #42.(Change in satisfaction with care from baseline to 3, 6, and 12 months)
- Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G).(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).(Change in patient activation from baseline to 3, 6, and 12 months)
- Hospice Care Use (Self-reported and Chart Review)(3, 6, and 12 months after patient enrollment)
- Hospitalization Visits (Self-reported and Chart Review)(3, 6, and 12 months after patient enrollment)
- Change in satisfaction with decision using the Satisfaction with Decision Scale (SWD)(Change in satisfaction with decision from baseline to 3, 6, and 12 months)
- Emergency Department Visits (Self-reported and Chart Review)(3, 6, and 12 months after patient enrollment)
- Documentation of goals of care discussions (Chart Review)(3, 6, and 12 months after patient enrollment)