Web-based Collaborative Care Intervention Study (WBCCI)
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| ClinicalTrials.gov Identifier: NCT02939755 |
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Recruitment Status :
Active, not recruiting
First Posted : October 20, 2016
Last Update Posted : October 14, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer Depression Fatigue Pain | Behavioral: Stepped collaborative care intervention Behavioral: Enhanced Usual Care | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 459 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 1, 2016 |
| Estimated Primary Completion Date : | July 1, 2023 |
| Estimated Study Completion Date : | September 1, 2023 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Behavioral: Stepped collaborative care intervention
Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional
Other Name: treatment |
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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.
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Behavioral: Enhanced Usual Care
usual care from health providers
Other Name: control |
- Depression [ Time Frame: change from baseline at 6 and 12 months ]CES-D questionnaire
- Pain level [ Time Frame: change from baseline at 6 and 12 months ]BPI
- Fatigue [ Time Frame: change from baseline at 6 and 12 months ]FACT-fatigue questionnaires
- Quality of life (QoL) [ Time Frame: change from baseline at 6 and 12 months ]FACT-G questionnaire
- serum IL-6, IL-1beta, IL-8, TNF-a and IFNg (pg/ml) [ Time Frame: change from baseline at 6 months and 12 months ]Blood sample collection and process
- serum CA19-9 (u/ml) [ Time Frame: change from baseline at 6 months and 12 months ]Blood sample collection and process
- serum CEA mg/L [ Time Frame: change from baseline at 6 months and 12 months ]Blood sample collection and process
- serum AFP ng/ml [ Time Frame: change from baseline at 6 months and 12 months ]Blood sample collection and process
- Caregivers' stress [ Time Frame: change from baseline at 6 and 12 months ]Caregiver's Stress, PSS questionnaire
- Caregivers' depression [ Time Frame: change from baseline at 6 and 12 months ]CES-D
- Caregivers' quality of life [ Time Frame: change from baseline at 6 and 12 months ]Dyadic Adjustment Scale
- Caregiver's blood pressure (mmHg) [ Time Frame: change from baseline at 6 and 12 months ]Blood pressure readings
- Caregiver's BMI (kg/m^2) [ Time Frame: change from baseline at 6 and 12 months ]Caregiver's height and weight calculations
- Caregiver's serum IL-6 (pg/ml) [ Time Frame: change from baseline at 6 and 12 months ]Blood sample collection and process
- Caregiver's serum HDL and LDL (mg/dl) [ Time Frame: change from baseline at 6 and 12 months ]Blood sample collection and process
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.
| Ages Eligible for Study: | 21 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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.
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
| United States, Pennsylvania | |
| UPMC East | |
| Monroeville, Pennsylvania, United States, 15146 | |
| The University of Pittsburgh's Medical Center Passavant Hospital | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| University of Pittsburgh Medical Center Mercy | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| University of Pittsburgh's Medical Center Montefiore Hospital | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| UPMC Presbyterian | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| UPMC St. Margaret | |
| Pittsburgh, Pennsylvania, United States, 15215 | |
| UPMC Horizen | |
| Pittsburgh, Pennsylvania, United States, 15219 | |
| Principal Investigator: | Jennifer L. Steel, PhD | UPMC Departemnt of Surgery |
| Responsible Party: | Jennifer Steel, Director and Associate Professor, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT02939755 |
| Other Study ID Numbers: |
STUDY19050065 |
| First Posted: | October 20, 2016 Key Record Dates |
| Last Update Posted: | October 14, 2022 |
| Last Verified: | October 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | De-Identified Data may be shared with investigators who request data from the Primary Investigator |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | Data will be available at the end of the study for up to one year. |
| Access Criteria: | Appropriate investigator credentials (MD, PhD) and request, and for up to one year after study completion |
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Collaborative care intervention Cancer Depression Palliative care |
Quality of life Fatigue Pain |
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Fatigue Depression Behavioral Symptoms |