Clinical trial NCT02939755: Web-based Collaborative Care Intervention Study
Official title: Collaborative Care Intervention for Cancer Patients and Their Family Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Depression
Fatigue
Pain
Keywords: Collaborative care intervention
Cancer
Depression
Palliative care
Quality of life
Fatigue
Pain
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 459
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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 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.

Primary outcomes:
measure: Quality of life (QoL)
timeFrame: change from baseline at 6 and 12 months
Secondary outcomes:
measure: serum Interleukin (IL)-6,(mg/L)
timeFrame: change from baseline at 6 months and 12 months
measure: serum Cancer Antigen 19-9 (u/ml)
timeFrame: change from baseline at 6 months and 12 months
measure: serum carcinoembryonic antigen (u/ml)
timeFrame: change from baseline at 6 months and 12 months
measure: serum Alpha feta protein (u/ml)
timeFrame: change from baseline at 6 months and 12 months
measure: Caregivers' stress
timeFrame: change from baseline at 6 and 12 months
measure: Caregivers' depression
timeFrame: change from baseline at 6 and 12 months
measure: dyadic adjustment
timeFrame: change from baseline at 6 and 12 months
measure: Caregiver's blood pressure
timeFrame: change from baseline at 6 and 12 months
measure: Caregiver's Body Mass Index
timeFrame: change from baseline at 6 and 12 months
measure: Caregiver's serum Interleukin-6
timeFrame: change from baseline at 6 and 12 months
measure: Caregiver's metabolic syndrome
timeFrame: change from baseline at 6 and 12 months
measure: Depression
timeFrame: change from baseline at 6 and 12 months
measure: Fatigue
timeFrame: change from baseline at 6 and 12 months
measure: Pain level
timeFrame: change from baseline at 6 and 12 months
measure: serum Interleukin IL-1beta,(mg/L)
timeFrame: change from baseline at 6 and 12 months
measure: serum Tumor necrosis factor-alpha ((mg/L)
timeFrame: change from baseline at 6 and 12 months
measure: serum Inteferon-gamma ((mg/L)
timeFrame: change from baseline at 6 and 12 months
Other outcomes:
measure: Health care utilization
timeFrame: 1 year
measure: Health care costs
timeFrame: 12 months
Locations:
city: Monroeville
country: United States
facility: UPMC East
state: Pennsylvania
city: Pittsburgh
country: United States
facility: The University of Pittsburgh's Medical Center Passavant Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Mercy
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh's Medical Center Montefiore Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC St. Margaret
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Horizen
state: Pennsylvania
Study officials:
affiliation: UPMC Departemnt of Surgery
name: Jennifer L. Steel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steel JL, Amin A, Peyser T, Olejniczak D, Antoni M, Carney M, Tillman E, Hecht CL, Pandya N, Miceli J, Reyes V, Nilsen M, Johnson J, Kiefer G, Pappu B, Zandberg DP, Geller DA. The benefits and consequences of the COVID-19 pandemic for patients diagnosed with cancer and their family caregivers. Psychooncology. 2022 Jun;31(6):1003-1012. doi: 10.1002/pon.5891. Epub 2022 Feb 1.
citation: Steel JL, Reyes V, Zandberg DP, Nilsen M, Terhorst L, Richards G, Pappu B, Kiefer G, Johnson J, Antoni M, Vodovotz Y, Spring M, Walker J, Geller DA. The next generation of collaborative care: The design of a novel web-based stepped collaborative care intervention delivered via telemedicine for people diagnosed with cancer. Contemp Clin Trials. 2021 Jun;105:106295. doi: 10.1016/j.cct.2021.106295. Epub 2021 Feb 5.