Collaborative Care Intervention for Cancer

Overseen By Jennifer L Steel, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Age < 21, Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 32

Duration: 12 months

Trial Summary

What is the purpose of this trial?

In an effort to reduce rural-urban disparities and improve the quality of cancer care for these patients, the objectives of this study will be to: (1) adapt the intervention to maximize effectiveness for rural, low-income patients, (2) test the effectiveness of the adapted intervention, and (3) prepare for implementation of the intervention in rural, low-income communities.

Research Team

Jennifer L Steel, PhD

Principal Investigator

UPMC Department of Surgery

Eligibility Criteria

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.

Inclusion Criteria

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

I am the spouse or live-in partner of a patient with advanced cancer at UPMC's Liver Cancer Center.

I have a diagnosed liver or related cancer and am expected to live at least one more year.

Exclusion Criteria

I am younger than 21 years old.

Caregivers: lack of fluency in English

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Adaptation

Adaptation of the stepped collaborative care intervention using mixed methods to address the contextual needs of patients

Not specified

Face-to-face qualitative interviews with 30 patients

Treatment

Randomized controlled trial of the adapted stepped collaborative care intervention for 242 patients

12 months

Biweekly contact by phone, face-to-face visits every 2 months

Follow-up

Participants are monitored for changes in quality of life, sleep quality, perceived stress, and depression

12 months

Treatment Details

Interventions

• Enhanced Usual Care
• Stepped collaborative care intervention

Trial Overview 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.

Participant Groups

Group I: Stepped collaborative care intervention Experimental Treatment 1 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 Care Active Control 1 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.

Enhanced Usual Care is already approved in United States, European Union, China for the following indications:

Approved in United States as Lactulose for:

• Hepatic encephalopathy
• Constipation

Approved in European Union as Lactulose for:

• Hepatic encephalopathy
• Constipation

Approved in China as Lactulose for:

• Hepatic encephalopathy
• Constipation

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+