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To test the efficacy of a web-based stepped collaborative care intervention to reduce symptoms of depression, pain, and fatigue and improve health-related quality of life (HRQL) in advanced cancer patients and to reduce stress and depression, and fewer CVD risk factors in caregivers.
The investigators will enroll patients at two UPMC sites: Montefiore Hospital, an academic medical center, and Passavant Hospital, a community based hospital. Based on our sample size estimate the investigators will have at least 364 patients and caregivers with complete data at 12 months follow up.
The patient and caregiver will be randomly assigned to one of two arms (intervention versus enhanced usual care) stratified by gender and vessel invasion. Because these factors are the two most robust prognostic factors in this patient population. At 6 and 12 months after enrollment, follow-up questionnaires and blood draws will be performed for patients and caregivers.
The stepped WBCC intervention includes at least biweekly contact from a care coordinator by phone and face to face visits occurring approximately every 2 months, and 24 hour 7 day a week access to a website. Patients randomized to the "enhanced usual care" arm receive their usual care from their medical team. However, if the patient scores in the clinical range on one or more of the three symptoms s/he will receive education about the symptom and be referred to the appropriate health care provider for further treatment in their community. The care coordinator will follow up with the patient after 3 weeks to assess barriers to treatment and assist further with accessing treatment if needed.
Intervention fidelity (e.g., consistency across care coordinators) will be reduced by requiring the care coordinators to follow a 300 page manual and providing standardized training by the PI who is a clinical psychologist. Dr. Steel (PI) has received training and certification from the American Psycho-Oncology Society in the design and analysis of psycho-oncology clinical trials and intervention fidelity. The study investigators will not prescribe any medications but rather make recommendations to the patient's oncologist, PCP, psychiatrist, or pain management specialist who will be free to accept or reject the recommendations by the study team. Medication type, dosage, and adherence to medication (e.g., self-report and pharmacy refills) will be recorded for patients in the WBCC intervention and enhanced usual care arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stepped collaborative care intervention | Experimental | The 'Stepped Collaborative Care Intervention' includes at least biweekly contact from a care coordinator by phone and face to face visits occurring approximately every 2 months, and 24 hour 7 day a week access to a website that was specifically designed during the pilot study for advanced cancer patients from socioeconomically disadvantaged backgrounds. |
|
| Enhanced Usual Care | Active Comparator | Patients randomized to the 'Enhanced Usual Care' arm receive their usual care from their medical team. However, if the patient scores in the clinical range on one or more of the three symptoms s/he will receive education about the symptom and be referred to the appropriate health care provider for further treatment in their community. The care coordinator will follow up with the patient after 3 weeks to assess barriers to treatment and assist further with accessing treatment if needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stepped collaborative care intervention | Behavioral | Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (QoL) | Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire | change from baseline at 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| serum Interleukin (IL)-6,(mg/L) | Blood sample collection and process | change from baseline at 6 months and 12 months |
| serum Cancer Antigen 19-9 (u/ml) | Blood sample collection and process |
| Measure | Description | Time Frame |
|---|---|---|
| Health care utilization | Emergency Room visits, 30- and 90-day readmissions, length of stay in the hospital. | 1 year |
| Health care costs | activity based costs |
Inclusion Criteria:
Patients:
Caregivers:
Exclusion Criteria:
Patients:
Caregivers:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer L. Steel, PhD | UPMC Departemnt of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC East | Monroeville | Pennsylvania | 15146 | United States | ||
| The University of Pittsburgh's Medical Center Passavant Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39585770 | Derived | Diamantis GN, Kim Y, Ofori-Atta Z, Devine L, Antoni MH, Reyes V, Johnson J, Kiefer G, Jiang Y, Zandberg DP, Nilsen M, Tohme S, Geller DA, Steel JL. The interdependence of depressive symptoms and sleep in dyads affected by cancer. Health Psychol. 2025 Apr;44(4):391-400. doi: 10.1037/hea0001449. Epub 2024 Nov 25. | |
| 38490230 | Derived |
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De-Identified Data may be shared with investigators who request data from the Primary Investigator
Data will be available at the end of the study for up to one year.
Appropriate investigator credentials (MD, PhD) and request, and for up to one year after study completion
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003863 | Depression |
| D005221 | Fatigue |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Enhanced Usual Care | Behavioral | usual care from health providers |
|
|
| change from baseline at 6 months and 12 months |
| serum carcinoembryonic antigen (u/ml) | Blood sample collection and process | change from baseline at 6 months and 12 months |
| serum Alpha feta protein (u/ml) | Blood sample collection and process | change from baseline at 6 months and 12 months |
| Caregivers' stress | Caregiver Quality of Life Scale- Cancer, Perceived Stress Scale | change from baseline at 6 and 12 months |
| Caregivers' depression | Center for Epidemiological Studies- Depression | change from baseline at 6 and 12 months |
| dyadic adjustment | Dyadic Adjustment Scale | change from baseline at 6 and 12 months |
| Caregiver's blood pressure | Blood pressure readings | change from baseline at 6 and 12 months |
| Caregiver's Body Mass Index | Caregiver's height and weight calculations in inches and pounds using BMI calculator | change from baseline at 6 and 12 months |
| Caregiver's serum Interleukin-6 | Blood sample collection and process | change from baseline at 6 and 12 months |
| Caregiver's metabolic syndrome | The caregiver meets or does not meet the American Heart Association criteria for metabolic syndrome | change from baseline at 6 and 12 months |
| Depression | Center for Epidemiological Studies- Depression | change from baseline at 6 and 12 months |
| Fatigue | Functional Assessment of Cancer Therapy -fatigue | change from baseline at 6 and 12 months |
| Pain level | Brief Pain Inventory | change from baseline at 6 and 12 months |
| serum Interleukin IL-1beta,(mg/L) | cytokine | change from baseline at 6 and 12 months |
| serum Tumor necrosis factor-alpha ((mg/L) | cytokine | change from baseline at 6 and 12 months |
| serum Inteferon-gamma ((mg/L) | cytokine | change from baseline at 6 and 12 months |
| 12 months |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| University of Pittsburgh Medical Center Mercy | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Pittsburgh's Medical Center Montefiore Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC St. Margaret | Pittsburgh | Pennsylvania | 15215 | United States |
| UPMC Horizen | Pittsburgh | Pennsylvania | 15219 | United States |
| Steel JL, George CJ, Terhorst L, Yabes JG, Reyes V, Zandberg DP, Nilsen M, Kiefer G, Johnson J, Marsh C, Bierenbaum J, Tageja N, Krauze M, VanderWeele R, Goel G, Ramineni G, Antoni M, Vodovotz Y, Walker J, Tohme S, Billiar T, Geller DA. Patient, family caregiver, and economic outcomes of an integrated screening and novel stepped collaborative care intervention in the oncology setting in the USA (CARES): a randomised, parallel, phase 3 trial. Lancet. 2024 Apr 6;403(10434):1351-1361. doi: 10.1016/S0140-6736(24)00015-1. Epub 2024 Mar 12. |
| 35083809 | Derived | Steel JL, Amin A, Peyser T, Olejniczak D, Antoni M, Carney M, Tillman E, Hecht CL, Pandya N, Miceli J, Reyes V, Nilsen M, Johnson J, Kiefer G, Pappu B, Zandberg DP, Geller DA. The benefits and consequences of the COVID-19 pandemic for patients diagnosed with cancer and their family caregivers. Psychooncology. 2022 Jun;31(6):1003-1012. doi: 10.1002/pon.5891. Epub 2022 Feb 1. |
| 33556589 | Derived | Steel JL, Reyes V, Zandberg DP, Nilsen M, Terhorst L, Richards G, Pappu B, Kiefer G, Johnson J, Antoni M, Vodovotz Y, Spring M, Walker J, Geller DA. The next generation of collaborative care: The design of a novel web-based stepped collaborative care intervention delivered via telemedicine for people diagnosed with cancer. Contemp Clin Trials. 2021 Jun;105:106295. doi: 10.1016/j.cct.2021.106295. Epub 2021 Feb 5. |
| D009461 | Neurologic Manifestations |