← Back to Search

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

Select...

I do not have any thought disorders, delusions, or thoughts of harming myself.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am younger than 21 years old.

Select...

I have not experienced severe mental health issues like hallucinations or thoughts of harming myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline in perceived stress at 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline in perceived stress at 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline in perceived stress 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

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

0 / 5Eligibility criteria met