Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer

Conditions
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End of Life, Cancer

Intervention / Treatment
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* Other: Receive technology-based supportive cancer care
* Behavioral: Receive redesigned team-based supportive cancer care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed patients with a solid tumor cancer diagnosis or hematologic malignancy Patients must have the ability to understand and willingness to provide consent Participants must speak English or Spanish 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster Randomized Controlled Trial among 24 clinics
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Technology-based supportive cancer care<br>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<br>* All participants will receive an electronic health record message or email with standardized information provided regarding advance care planning and symptom management.<br>* Other names: Technology-based SCC approach;|
| Experimental: Redesigned team-based supportive cancer care<br>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<br>* 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.<br>* Other names: Patients Activated in Cancer care through Teams (PACT), Redesigned SCC team-based approach;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasms, 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, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Lung Diseases, Respiratory Tract Diseases, Urogenital Neoplasms, Carcinoma, Bronchogenic