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Web-based Collaborative Care Intervention Study

Collaborative Care Intervention for Cancer Patients and Their Family Caregivers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02939755
Acronym
WBCCI
Enrollment
459
Registered
2016-10-20
Start date
2016-12-01
Completion date
2023-07-01
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Depression, Fatigue, Pain

Keywords

Collaborative care intervention, Cancer, Depression, Palliative care, Quality of life, Fatigue, Pain

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.

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.

Interventions

Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional

BEHAVIORALEnhanced Usual Care

usual care from health providers

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Quality of life (QoL)change from baseline at 6 and 12 monthsFunctional Assessment of Cancer Therapy - General (FACT-G) questionnaire

Secondary

MeasureTime frameDescription
serum Interleukin (IL)-6,(mg/L)change from baseline at 6 months and 12 monthsBlood sample collection and process
serum Cancer Antigen 19-9 (u/ml)change from baseline at 6 months and 12 monthsBlood sample collection and process
serum carcinoembryonic antigen (u/ml)change from baseline at 6 months and 12 monthsBlood sample collection and process
serum Alpha feta protein (u/ml)change from baseline at 6 months and 12 monthsBlood sample collection and process
Caregivers' stresschange from baseline at 6 and 12 monthsCaregiver Quality of Life Scale- Cancer, Perceived Stress Scale
Caregivers' depressionchange from baseline at 6 and 12 monthsCenter for Epidemiological Studies- Depression
dyadic adjustmentchange from baseline at 6 and 12 monthsDyadic Adjustment Scale
Caregiver's blood pressurechange from baseline at 6 and 12 monthsBlood pressure readings
Caregiver's Body Mass Indexchange from baseline at 6 and 12 monthsCaregiver's height and weight calculations in inches and pounds using BMI calculator
serum Tumor necrosis factor-alpha ((mg/L)change from baseline at 6 and 12 monthscytokine
serum Inteferon-gamma ((mg/L)change from baseline at 6 and 12 monthscytokine
Caregiver's serum Interleukin-6change from baseline at 6 and 12 monthsBlood sample collection and process
Caregiver's metabolic syndromechange from baseline at 6 and 12 monthsThe caregiver meets or does not meet the American Heart Association criteria for metabolic syndrome
Depressionchange from baseline at 6 and 12 monthsCenter for Epidemiological Studies- Depression
Fatiguechange from baseline at 6 and 12 monthsFunctional Assessment of Cancer Therapy -fatigue
Pain levelchange from baseline at 6 and 12 monthsBrief Pain Inventory
serum Interleukin IL-1beta,(mg/L)change from baseline at 6 and 12 monthscytokine

Other

MeasureTime frameDescription
Health care utilization1 yearEmergency Room visits, 30- and 90-day readmissions, length of stay in the hospital.
Health care costs12 monthsactivity based costs

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026