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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
Caregivers: a spouse or cohabitating intimate partner of an advanced cancer patient being evaluated at the UPMC's Liver Cancer Center
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline in depression at 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 am the spouse or live-in partner of a patient with advanced cancer at UPMC's Liver Cancer Center.
Select...
I have a diagnosed liver or related cancer and am expected to live at least one more year.
Select...
I am older than 21 years.
Select...
I am older than 21 years.

Timeline

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

Treatment Details

Study Objectives

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

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
1,712 Previous Clinical Trials
16,345,899 Total Patients Enrolled
119 Trials studying Depression
33,984 Patients Enrolled for Depression
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,912,763 Total Patients Enrolled
81 Trials studying Depression
65,595 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarians able to enroll in this investigation?

"According to the eligibility guidelines, potential participants in this trial must be between 21 and 100 years old. Out of the 1,491 total clinical trials, 271 are for patients under 18 while 1,220 are for those over 65."

Answered by AI

What are the eligibility requirements for patients who want to join this trial?

"To join this study, applicants must meet the following requirements: have a spouse or cohabitating intimate partner who is being treated for cancer at the UPMC Liver cancer Center, be aged 21 years or older, and have no evidence of thought disorder, delusions, or active suicidal ideation."

Answered by AI

Are we still looking for candidates for this research project?

"Unfortunately, this particular study is not recruiting at this time. The last update on the website was on June 15th, 2022. Although this study has completed recruitment, there are 1652 other trials that are still looking for patients."

Answered by AI
~341 spots leftby Sep 2029