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2022-06-24
2028-01-31
2028-02-28
2996
NCT05297734
Stanford University
Stanford University
INTERVENTIONAL
Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-03-17 | N/A | 2025-03-15 |
2022-03-17 | N/A | 2025-03-19 |
2022-03-28 | N/A | 2025-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Health Services Research
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| 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
|
| 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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | Change in health-related quality of life from baseline to 3 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 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). | Each patient will receive a validated patient activation survey (PAM-13) to assess their activation at baseline, 3 months, 6 months, and 12 months. | Change in patient activation from baseline to 3, 6, and 12 months |
| 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. | Change in satisfaction with care from baseline to 3, 6, and 12 months |
| 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. | Change in satisfaction with decision from baseline to 3, 6, and 12 months |
| Palliative Care Use (Self-reported and Chart Review) | 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. | 3, 6, and 12 months after patient enrollment |
| Hospice Care Use (Self-reported and Chart Review) | 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. | 3, 6, and 12 months after patient enrollment |
| Emergency Department Visits (Self-reported and Chart Review) | Emergency Department use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, and 12 months after enrollment. | 3, 6, and 12 months after patient enrollment |
| Hospitalization Visits (Self-reported and Chart Review) | 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. | 3, 6, and 12 months after patient enrollment |
| Documentation of goals of care discussions (Chart Review) | 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. | 3, 6, and 12 months after patient enrollment |
| Documentation of symptom discussions (Chart Review) | Documentation of symptom discussions will be abstracted by electronic medical record chart review for each patient at 3, 6, and 12 months after enrollment. | 3, 6, and 12 months after patient enrollment |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Manali I Patel, MD MPH MS Phone Number: 6507234000 Email: manalip@stanford.edu |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
