Cancer, End of Life
Conditions
Keywords
Carcinoma, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Melanoma, Pancreatic Neoplasms, Sarcoma, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Stomach Neoplasms, Glioblastoma, Rectal Neoplasms, Colonic Neoplasms, Esophageal Neoplasms, Breast Neoplasms, Carcinoma, Renal Cell, Skin Neoplasms, Small Cell Lung Carcinoma, Osteosarcoma, Myelodysplastic Syndromes, Disease Progression, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Lung Diseases, Respiratory Tract Diseases, Urogenital Neoplasms, Carcinoma, Bronchogenic
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.
Interventions
OTHERReceive 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.
BEHAVIORALReceive 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.
Sponsors
Stanford University
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Cluster Randomized Controlled Trial among 26 clinics
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Each patient will receive a health-related quality of life survey (FACT-G) at baseline, 3 months, 6 months, 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 | 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 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 | Each patient will receive a validated satisfaction with care survey at baseline, 3 months, 6 months, and 12 months. |
| 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 | Each patient will receive a validated satisfaction with decision survey at baseline, 3 months, 6 months and 12 months. |
| Palliative Care Use (Self-reported and Chart Review) | 3, 6, and 12 months after patient enrollment | 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. |
| Hospice Care Use (Self-reported and Chart Review) | 3, 6, and 12 months after patient enrollment | 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. |
| Emergency Department Visits (Self-reported and Chart Review) | 3, 6, and 12 months after patient enrollment | Emergency Department use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, and 12 months after enrollment. |
| Hospitalization Visits (Self-reported and Chart Review) | 3, 6, and 12 months after patient enrollment | 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. |
| Documentation of goals of care discussions (Chart Review) | 3, 6, and 12 months after patient enrollment | 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. |
| Documentation of symptom discussions (Chart Review) | 3, 6, and 12 months after patient enrollment | Documentation of symptom discussions will be abstracted by electronic medical record chart review for each patient at 3, 6, and 12 months after enrollment. |
Countries
United States
Contacts
CONTACTManali I Patel, MD MPH MS
Outcome results
None listed