Web-based Collaborative Care Intervention Study

Depression Clinical Trial

— WBCCI  

Official title:

Collaborative Care Intervention for Cancer Patients and Their Family Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02939755
• Other study ID #: STUDY19050065
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: July 1, 2023

Study information

• Verified date: September 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Depression
• Fatigue
• Pain

Intervention

Behavioral:
• Stepped collaborative care intervention
Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional
• Enhanced Usual Care
usual care from health providers

Locations

Country	Name	City	State
United States	UPMC East	Monroeville	Pennsylvania
United States	The University of Pittsburgh's Medical Center Passavant Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center Mercy	Pittsburgh	Pennsylvania
United States	University of Pittsburgh's Medical Center Montefiore Hospital	Pittsburgh	Pennsylvania
United States	UPMC Horizen	Pittsburgh	Pennsylvania
United States	UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	UPMC St. Margaret	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health care utilization	Emergency Room visits, 30- and 90-day readmissions, length of stay in the hospital.	1 year
Other	Health care costs	activity based costs	12 months
Primary	Quality of life (QoL)	Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire	change from baseline at 6 and 12 months
Secondary	serum Interleukin (IL)-6,(mg/L)	Blood sample collection and process	change from baseline at 6 months and 12 months
Secondary	serum Cancer Antigen 19-9 (u/ml)	Blood sample collection and process	change from baseline at 6 months and 12 months
Secondary	serum carcinoembryonic antigen (u/ml)	Blood sample collection and process	change from baseline at 6 months and 12 months
Secondary	serum Alpha feta protein (u/ml)	Blood sample collection and process	change from baseline at 6 months and 12 months
Secondary	Caregivers' stress	Caregiver Quality of Life Scale- Cancer, Perceived Stress Scale	change from baseline at 6 and 12 months
Secondary	Caregivers' depression	Center for Epidemiological Studies- Depression	change from baseline at 6 and 12 months
Secondary	dyadic adjustment	Dyadic Adjustment Scale	change from baseline at 6 and 12 months
Secondary	Caregiver's blood pressure	Blood pressure readings	change from baseline at 6 and 12 months
Secondary	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
Secondary	Caregiver's serum Interleukin-6	Blood sample collection and process	change from baseline at 6 and 12 months
Secondary	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
Secondary	Depression	Center for Epidemiological Studies- Depression	change from baseline at 6 and 12 months
Secondary	Fatigue	Functional Assessment of Cancer Therapy -fatigue	change from baseline at 6 and 12 months
Secondary	Pain level	Brief Pain Inventory	change from baseline at 6 and 12 months
Secondary	serum Interleukin IL-1beta,(mg/L)	cytokine	change from baseline at 6 and 12 months
Secondary	serum Tumor necrosis factor-alpha ((mg/L)	cytokine	change from baseline at 6 and 12 months
Secondary	serum Inteferon-gamma ((mg/L)	cytokine	change from baseline at 6 and 12 months