Stepped collaborative care intervention
BehavioralUsing website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional
Other names: treatment
NCT Number: NCT02939755
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.
Looking for future studies?
Notify Me21 year–100 year
All sexes
Interventional
Not applicable
UPMC East, Monroeville, Pennsylvania, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients:
Caregivers:
Exclusion criteria
Patients:
Caregivers:
Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional
Other names: treatment
usual care from health providers
Other names: control
Time frame: change from baseline at 6 and 12 months
Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire
Time frame: change from baseline at 6 months and 12 months
Blood sample collection and process
Time frame: change from baseline at 6 months and 12 months
Blood sample collection and process
Time frame: change from baseline at 6 months and 12 months
Blood sample collection and process
Time frame: change from baseline at 6 months and 12 months
Blood sample collection and process
Time frame: change from baseline at 6 and 12 months
Caregiver Quality of Life Scale- Cancer, Perceived Stress Scale
Time frame: change from baseline at 6 and 12 months
Center for Epidemiological Studies- Depression
Time frame: change from baseline at 6 and 12 months
Dyadic Adjustment Scale
Time frame: change from baseline at 6 and 12 months
Blood pressure readings
Time frame: change from baseline at 6 and 12 months
Caregiver's height and weight calculations in inches and pounds using BMI calculator
Time frame: change from baseline at 6 and 12 months
Blood sample collection and process
Time frame: change from baseline at 6 and 12 months
The caregiver meets or does not meet the American Heart Association criteria for metabolic syndrome
Time frame: change from baseline at 6 and 12 months
Center for Epidemiological Studies- Depression
Time frame: change from baseline at 6 and 12 months
Functional Assessment of Cancer Therapy -fatigue
Time frame: change from baseline at 6 and 12 months
Brief Pain Inventory
Time frame: change from baseline at 6 and 12 months
cytokine
Time frame: change from baseline at 6 and 12 months
cytokine
Time frame: change from baseline at 6 and 12 months
cytokine
Time frame: 1 year
Emergency Room visits, 30- and 90-day readmissions, length of stay in the hospital.
Time frame: 12 months
activity based costs
University of Pittsburgh
Other
Collaborative Care Intervention for Cancer Patients and Their Family Caregivers
Acronym: WBCCI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00769301
Behavior, Behavioral Symptoms
Fredrikstad, Norway
View Trial DetailsNCT05601206
Behavior, Behavioral Symptoms
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT05869604
Behavior, Cancer
Durham, North Carolina, United States
View Trial DetailsNCT04035447
Breast Cancer, Breast Diseases
Durham, North Carolina, United States
View Trial Details