Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Receive technology-based supportive cancer care
Other interventionAll participants will receive an electronic health record message or email with standardized information provided regarding advance care planning and symptom management.
Receive redesigned team-based supportive cancer care
BehavioralLay 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.
Treatment groups
2,996 Participants
are divided into 2 treatment groupsGroup A: Technology-based supportive cancer careActive comparator 1 intervention
Group B: Redesigned team-based supportive cancer careExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G).
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 3 monthsSecondary outcomes
1
Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G).
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 months2
Change in patient activation using the Patient Activation Measure (PAM-13).
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 patient activation from baseline to 3, 6, and 12 months3
Change in satisfaction with care using the Consumer Assessment of Health Care (Providers and Systems (CAHPS) Cancer Care Survey Questions #39 and #42.
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 care from baseline to 3, 6, and 12 months4
Change in satisfaction with decision using the Satisfaction with Decision Scale (SWD)
Each patient will receive a validated satisfaction with decision survey at baseline, 3 months, 6 months and 12 months.
Time frame
Change in satisfaction with decision from baseline to 3, 6, and 12 monthsOther outcomes
1
Time Toxicity
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 enrollment2
Financial Toxicity
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.
Time frame
3, 6, and 12 months after patient enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov