WBCCI: Web-based Collaborative Care Intervention Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Stepped collaborative care intervention 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. |
Behavioral: Stepped collaborative care intervention
Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional
Other Names:
|
| Active Comparator: Enhanced Usual Care 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. |
Behavioral: Enhanced Usual Care
usual care from health providers
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Depression [change from baseline at 6 and 12 months]
CES-D questionnaire
- Pain level [change from baseline at 6 and 12 months]
BPI
- Fatigue [change from baseline at 6 and 12 months]
FACT-fatigue questionnaires
- Quality of life (QoL) [change from baseline at 6 and 12 months]
FACT-G questionnaire
Secondary Outcome Measures
- serum IL-6, IL-1beta, IL-8, TNF-a and IFNg (pg/ml) [change from baseline at 6 months and 12 months]
Blood sample collection and process
- serum CA19-9 (u/ml) [change from baseline at 6 months and 12 months]
Blood sample collection and process
- serum CEA mg/L [change from baseline at 6 months and 12 months]
Blood sample collection and process
- serum AFP ng/ml [change from baseline at 6 months and 12 months]
Blood sample collection and process
- Caregivers' stress [change from baseline at 6 and 12 months]
Caregiver's Stress, PSS questionnaire
- Caregivers' depression [change from baseline at 6 and 12 months]
CES-D
- Caregivers' quality of life [change from baseline at 6 and 12 months]
Dyadic Adjustment Scale
- Caregiver's blood pressure (mmHg) [change from baseline at 6 and 12 months]
Blood pressure readings
- Caregiver's BMI (kg/m^2) [change from baseline at 6 and 12 months]
Caregiver's height and weight calculations
- Caregiver's serum IL-6 (pg/ml) [change from baseline at 6 and 12 months]
Blood sample collection and process
- Caregiver's serum HDL and LDL (mg/dl) [change from baseline at 6 and 12 months]
Blood sample collection and process
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients:
-
biopsy and/or radiograph proven diagnosis of hepatocellular carcinoma,cholangiocarcinoma, gallbladder carcinoma or breast, ovarian, or colorectal cancer with liver metastases with a life expectancy of at least one year;
-
age >21 years;
-
no evidence of thought disorder, delusions, or active suicidal ideation is observed or reported.
Caregivers:
-
a spouse or cohabitating intimate partner of an advanced cancer patient being evaluated at the UPMC's Liver Cancer Center and
-
age >21 years
Exclusion Criteria:
Patients:
-
age < 21 years,
-
lack of fluency in English,
-
evidence of thought disorder, delusions, hallucinations, or suicidal ideation.
Caregivers:
-
lack of fluency in English; and
-
evidence of thought disorder, delusions, hallucinations, or suicidal ideation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UPMC East | Monroeville | Pennsylvania | United States | 15146 |
| 2 | The University of Pittsburgh's Medical Center Passavant Hospital | Pittsburgh | Pennsylvania | United States | 15213 |
| 3 | University of Pittsburgh Medical Center Mercy | Pittsburgh | Pennsylvania | United States | 15213 |
| 4 | University of Pittsburgh's Medical Center Montefiore Hospital | Pittsburgh | Pennsylvania | United States | 15213 |
| 5 | UPMC Presbyterian | Pittsburgh | Pennsylvania | United States | 15213 |
| 6 | UPMC St. Margaret | Pittsburgh | Pennsylvania | United States | 15215 |
| 7 | UPMC Horizen | Pittsburgh | Pennsylvania | United States | 15219 |
Sponsors and Collaborators
- University of Pittsburgh
Investigators
- Principal Investigator: Jennifer L. Steel, PhD, UPMC Departemnt of Surgery
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HCC# 20-066