Skip to main content
OpenTrials
Completed

NCT Number: NCT02939755

Web-based Collaborative Care Intervention Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC East, Monroeville, Pennsylvania, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stepped collaborative care intervention

Behavioral

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

Other names: treatment

Enhanced Usual Care

Behavioral

usual care from health providers

Other names: control

Primary outcomes

  1. Quality of life (QoL)

    Time frame: change from baseline at 6 and 12 months

    Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire

Secondary outcomes

  1. serum Interleukin (IL)-6,(mg/L)

    Time frame: change from baseline at 6 months and 12 months

    Blood sample collection and process

  2. serum Cancer Antigen 19-9 (u/ml)

    Time frame: change from baseline at 6 months and 12 months

    Blood sample collection and process

  3. serum carcinoembryonic antigen (u/ml)

    Time frame: change from baseline at 6 months and 12 months

    Blood sample collection and process

  4. serum Alpha feta protein (u/ml)

    Time frame: change from baseline at 6 months and 12 months

    Blood sample collection and process

  5. Caregivers' stress

    Time frame: change from baseline at 6 and 12 months

    Caregiver Quality of Life Scale- Cancer, Perceived Stress Scale

  6. Caregivers' depression

    Time frame: change from baseline at 6 and 12 months

    Center for Epidemiological Studies- Depression

  7. dyadic adjustment

    Time frame: change from baseline at 6 and 12 months

    Dyadic Adjustment Scale

  8. Caregiver's blood pressure

    Time frame: change from baseline at 6 and 12 months

    Blood pressure readings

  9. Caregiver's Body Mass Index

    Time frame: change from baseline at 6 and 12 months

    Caregiver's height and weight calculations in inches and pounds using BMI calculator

  10. Caregiver's serum Interleukin-6

    Time frame: change from baseline at 6 and 12 months

    Blood sample collection and process

  11. Caregiver's metabolic syndrome

    Time frame: change from baseline at 6 and 12 months

    The caregiver meets or does not meet the American Heart Association criteria for metabolic syndrome

  12. Depression

    Time frame: change from baseline at 6 and 12 months

    Center for Epidemiological Studies- Depression

  13. Fatigue

    Time frame: change from baseline at 6 and 12 months

    Functional Assessment of Cancer Therapy -fatigue

  14. Pain level

    Time frame: change from baseline at 6 and 12 months

    Brief Pain Inventory

  15. serum Interleukin IL-1beta,(mg/L)

    Time frame: change from baseline at 6 and 12 months

    cytokine

  16. serum Tumor necrosis factor-alpha ((mg/L)

    Time frame: change from baseline at 6 and 12 months

    cytokine

  17. serum Inteferon-gamma ((mg/L)

    Time frame: change from baseline at 6 and 12 months

    cytokine

Other outcomes

  1. Health care utilization

    Time frame: 1 year

    Emergency Room visits, 30- and 90-day readmissions, length of stay in the hospital.

  2. Health care costs

    Time frame: 12 months

    activity based costs

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Collaborative Care Intervention for Cancer Patients and Their Family Caregivers

Acronym: WBCCI

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Oct 20, 2016
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.