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Collaborative Care Intervention for Cancer

N/A
Waitlist Available
Led By Jennifer L Steel, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
no evidence of thought disorder, delusions, or active suicidal ideation is observed or reported
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
Must not have
Patients: age < 21 years
evidence of thought disorder, delusions, hallucinations, or suicidal ideation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline of interpersonal support evaluation at 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing an intervention to improve cancer care for rural, low-income patients and reduce disparities between rural and urban areas.

Who is the study for?
This trial is for adults over 21 with certain types of advanced cancer (like liver, gallbladder, breast, ovarian, or colorectal with liver metastases) and a life expectancy of at least one year. It's also for their adult caregivers without mental health conditions like thought disorders or suicidal thoughts. Participants must speak English fluently.
What is being tested?
The study is testing a 'stepped collaborative care intervention' against 'Enhanced Usual Care' to see if it can improve the quality of life for rural cancer patients and their caregivers by adapting support specifically for low-income communities.
What are the potential side effects?
Since this trial focuses on care interventions rather than medications, side effects are not typical as in drug trials but may include emotional distress due to discussing sensitive topics related to illness and caregiving.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have any thought disorders, delusions, or thoughts of harming myself.
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I have a diagnosed liver or related cancer and am expected to live at least one more year.
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I am older than 21 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am younger than 21 years old.
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I have not experienced severe mental health issues like hallucinations or thoughts of harming myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline in quality of life at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline in quality of life at 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blood coagulation tests
Blood coagulation tests
EuroQOL-5 Dimension Questionnaire (EQ-5D)
Secondary study objectives
Interpersonal Support Evaluation List (ISEL)
Perceived Stress Scale (PSS)
Pittsburgh Sleep Quality Index (PSQI)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Stepped collaborative care interventionExperimental Treatment1 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.
Group II: Enhanced Usual CareActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stepped collaborative care intervention
2016
N/A
~460

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,792 Previous Clinical Trials
16,359,474 Total Patients Enrolled
123 Trials studying Depression
34,137 Patients Enrolled for Depression
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,111,568 Total Patients Enrolled
86 Trials studying Depression
66,169 Patients Enrolled for Depression
Jennifer L Steel, PhDPrincipal InvestigatorUPMC Department of Surgery
1 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Enhanced Usual Care Clinical Trial Eligibility Overview. Trial Name: NCT05091593 — N/A
Depression Research Study Groups: Stepped collaborative care intervention, Enhanced Usual Care
Depression Clinical Trial 2023: Enhanced Usual Care Highlights & Side Effects. Trial Name: NCT05091593 — N/A
Enhanced Usual Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05091593 — N/A
~341 spots leftby Sep 2030