Web-based Collaborative Care Intervention Study



Status:Recruiting
Conditions:Cancer, Cancer, Chronic Pain, Depression, Other Indications
Therapuetic Areas:Musculoskeletal, Oncology, Psychiatry / Psychology, Other
Healthy:No
Age Range:21 - 100
Updated:9/9/2018
Start Date:December 2016
End Date:September 2022
Contact:Jennifer L. Steel, PhD
Email:steeljl@upmc.edu
Phone:412-692-2041

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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.

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.

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 LCC; 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.
We found this trial at
7
sites
1400 Locust Street
Pittsburgh, Pennsylvania 15219
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Monroeville, Pennsylvania 15146
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200 Meyran Avenue
Pittsburgh, Pennsylvania 15213
Phone: 412-692-2041
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1400 Locust Street
Pittsburgh, Pennsylvania 15219
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3459 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Principal Investigator: Jennifer L. Steel, PhD
Phone: 412-692-2041
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Pittsburgh, Pennsylvania 15213
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Pittsburgh, Pennsylvania 15215
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