Web-based Collaborative Care Intervention Study (WBCCI)

Collaborative Care Intervention for Cancer Patients and Their Family Caregivers

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.

Study Overview

• Status: Completed
• Conditions: Depression; Pain; Cancer; Fatigue
• Intervention / Treatment: Behavioral: Stepped collaborative care intervention; Behavioral: Enhanced Usual Care

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 Type: Interventional
• Enrollment (Actual): 459
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Monroeville, Pennsylvania, United States, 15146
      • UPMC East
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Presbyterian
    • Pittsburgh, Pennsylvania, United States, 15215
      • UPMC St. Margaret
    • Pittsburgh, Pennsylvania, United States, 15213
      • The University of Pittsburgh's Medical Center Passavant Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center Mercy
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh's Medical Center Montefiore Hospital
    • Pittsburgh, Pennsylvania, United States, 15219
      • UPMC Horizen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: treatment
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: control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	12 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Jennifer L. Steel, PhD, UPMC Departemnt of Surgery

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: October 14, 2016
• First Submitted That Met QC Criteria: October 18, 2016
• First Posted (Estimated): October 20, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Cancer; Pain; Quality of life; Palliative care; Fatigue; Collaborative care intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Fatigue
• Other Study ID Numbers: STUDY19050065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-Identified Data may be shared with investigators who request data from the Primary Investigator
• IPD Sharing Time Frame: Data will be available at the end of the study for up to one year.
• IPD Sharing Access Criteria: Appropriate investigator credentials (MD, PhD) and request, and for up to one year after study completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP