Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Web-based Collaborative Care Intervention Study (WBCCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02939755
Recruitment Status : Recruiting
First Posted : October 20, 2016
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer Steel, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Cancer Depression Fatigue Pain Behavioral: Stepped collaborative care intervention Behavioral: Enhanced Usual Care Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Collaborative Care Intervention for Cancer Patients and Their Family Caregivers
Study Start Date : December 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Fatigue

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 Name: 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 Name: control




Primary Outcome Measures :
  1. Depression [ Time Frame: change from baseline at 6 and 12 months ]
    CES-D questionnaire

  2. Pain level [ Time Frame: change from baseline at 6 and 12 months ]
    BPI

  3. Fatigue [ Time Frame: change from baseline at 6 and 12 months ]
    FACT-fatigue questionnaires

  4. Quality of life (QoL) [ Time Frame: change from baseline at 6 and 12 months ]
    FACT-G questionnaire


Secondary Outcome Measures :
  1. serum IL-6, IL-1beta, IL-8, TNF-a and IFNg (pg/ml) [ Time Frame: change from baseline at 6 months and 12 months ]
  2. serum CA19-9 (u/ml) [ Time Frame: change from baseline at 6 months and 12 months ]
  3. serum CEA mg/L [ Time Frame: change from baseline at 6 months and 12 months ]
  4. serum AFP ng/ml [ Time Frame: change from baseline at 6 months and 12 months ]
  5. Caregivers' stress [ Time Frame: change from baseline at 6 and 12 months ]
    Caregiver's Stress, PSS questionnaire

  6. Caregivers' depression [ Time Frame: change from baseline at 6 and 12 months ]
    CES-D

  7. Caregivers' quality of life [ Time Frame: change from baseline at 6 and 12 months ]
    Dyadic Adjustment scale

  8. Caregiver's blood pressure (mmHg) [ Time Frame: change from baseline at 6 and 12 months ]
  9. Caregiver's BMI (kg/m^2) [ Time Frame: change from baseline at 6 and 12 months ]
  10. Caregiver's serum IL-6 (pg/ml) [ Time Frame: change from baseline at 6 and 12 months ]
  11. Caregiver's serum HDL and LDL (mg/dl) [ Time Frame: change from baseline at 6 and 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939755


Contacts
Layout table for location contacts
Contact: Jennifer L. Steel, PhD 412-692-2041 steeljl@upmc.edu

Locations
Layout table for location information
United States, Pennsylvania
UPMC East Recruiting
Monroeville, Pennsylvania, United States, 15146
The University of Pittsburgh's Medical Center Passavant Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jennifer Steel, PhD    412-692-2041    STEELJL@UPMC.EDU   
University of Pittsburgh Medical Center Mercy Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh's Medical Center Montefiore Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jennifer Steel, PhD    412-692-2041    steeljl@upmc.edu   
Principal Investigator: Jennifer L. Steel, PhD         
UPMC Presbyterian Recruiting
Pittsburgh, Pennsylvania, United States, 15213
UPMC St. Margaret Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15215
UPMC Horizen Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15219
Sponsors and Collaborators
University of Pittsburgh
Investigators
Layout table for investigator information
Principal Investigator: Jennifer L. Steel, PhD UPMC Departemnt of Surgery

Layout table for additonal information
Responsible Party: Jennifer Steel, Director and Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02939755     History of Changes
Other Study ID Numbers: PRO15030290
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jennifer Steel, University of Pittsburgh:
Collaborative care intervention
Cancer
Depression
Palliative care
Quality of life
Fatigue
Pain

Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Fatigue
Behavioral Symptoms
Signs and Symptoms