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Trial Title:
Collaborative Care Intervention for Cancer Patients and Their Family Caregivers -LITE
NCT ID:
NCT05601206
Condition:
Cancer
Depression
Fatigue
Pain
Sleep
Conditions: Official terms:
Fatigue
Depression
Conditions: Keywords:
Cancer Depression Fatigue Pain
Study type:
Interventional
Study phase:
N/A
Overall status:
Suspended
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized controlled trial
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Stepped collaborative care intervention
Description:
Using website that was specifically designed for advanced cancer patient, collaborative
with treatment from health professional
Arm group label:
Stepped collaborative care intervention
Other name:
Treatment
Intervention type:
Behavioral
Intervention name:
Enhanced Usual Care
Description:
Usual care from health providers
Arm group label:
Enhanced Usual Care
Other name:
Control
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 intervention is designed to maintain quality of life for those in greatest need and
least access to resources. This innovative and scalable web-based collaborative care
intervention is expected not only to improve patients' quality of life, at the end of
life, but also reduce caregiver stress and depression, and potentially health morbidity
and mortality of patients and spousal and intimate partner caregivers from
socioeconomically disadvantaged backgrounds. Study findings are expected to lead to
research examining the dissemination and implementation of the intervention.
Criteria for 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
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:
Age < 21 years, Lack of fluency in English, Evidence of thought disorder, delusions,
hallucinations, or suicidal ideation.
Gender:
All
Minimum age:
21 Years
Maximum age:
100 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of Pittsburgh Medical Center Montefiore Liver Cancer Center
Address:
City:
Pittsburgh
Zip:
15213
Country:
United States
Facility:
Name:
University of Pittsburgh's Medical Center Montefiore Hospital
Address:
City:
Pittsburgh
Zip:
15213
Country:
United States
Start date:
November 14, 2023
Completion date:
June 1, 2027
Lead sponsor:
Agency:
University of Pittsburgh
Agency class:
Other
Source:
University of Pittsburgh
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05601206
