Web-based Collaborative Care Intervention Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

459 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2023-07-01

Brief Summary

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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

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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.

Conditions

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Cancer Depression Fatigue Pain

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Stepped collaborative care intervention

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type BEHAVIORAL

usual care from health providers

Interventions

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Stepped collaborative care intervention

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

Intervention Type BEHAVIORAL

Enhanced Usual Care

usual care from health providers

Intervention Type BEHAVIORAL

Other Intervention Names

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treatment control

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jennifer Steel

Director and Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer L. Steel, PhD

Role: PRINCIPAL_INVESTIGATOR

UPMC Departemnt of Surgery

Locations

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