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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve cancer care for patients in rural, low-income areas. It will test two approaches: Enhanced Usual Care, which provides usual care with added support and education, and Stepped Collaborative Care Intervention, which offers more intensive care coordination with regular check-ins and online resources. Suitable participants include those diagnosed with certain types of cancer, such as liver or breast cancer, who have a year or more to live and no severe mental health issues. The goal is to find better ways to support cancer patients in areas where accessing care can be challenging.

As an unphased trial, this study presents a unique opportunity to contribute to innovative cancer care solutions in underserved communities.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the stepped collaborative care approach is generally easy for patients to handle. Studies have found that this type of care can help manage symptoms like depression, pain, and tiredness in cancer patients. This method includes regular contact with a care coordinator and access to resources specifically for patients with advanced cancer. These studies have reported no major safety issues. Overall, this care aims to improve quality of life without causing significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Collaborative Care Intervention for cancer because it offers a unique approach to supporting patients, especially those from socioeconomically disadvantaged backgrounds. Unlike standard care, which often relies solely on routine visits with a medical team, the Stepped Collaborative Care Intervention provides biweekly contact with a care coordinator and face-to-face visits every two months. Additionally, patients have 24/7 access to a specially designed website for advanced cancer care, enhancing support outside typical medical appointments. This level of continuous, personalized care aims to address barriers to treatment and ensure patients receive timely assistance, potentially improving both their health outcomes and quality of life.

What evidence suggests that this trial's treatments could be effective for cancer care?

Research has shown that the stepped collaborative care approach, a treatment option in this trial, effectively manages cancer symptoms. Studies have found that patients using this method experience significant improvements in their quality of life within six months. This approach involves regular contact with a care coordinator and access to helpful resources, easing symptoms like depression, pain, and fatigue. These improvements often surpass those seen with standard care. Meanwhile, participants in the Enhanced Usual Care arm receive their usual care with additional support if needed. The stepped collaborative care method is designed to be flexible and meet patient needs, making it a promising option for improving cancer care, especially for those from disadvantaged backgrounds. ^{1 2 6 7 8}

Who Is on the Research Team?

Jennifer L Steel, PhD

Principal Investigator

UPMC Department of Surgery

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38490230/

Patient, family caregiver, and economic outcomes of ... - PubMed Patients in the stepped collaborative care group had a greater 0-6-month improvement in health-related quality of life than patients in the ...

2. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(24)00015-1/abstract

Patient, family caregiver, and economic outcomes of an ... This trial aimed to test the efficacy of an integrated screening and novel stepped collaborative care intervention versus standard of care for ...

3. academic.oup.com academic.oup.com/jnci/advance-article/doi/10.1093/jnci/djaf153/8173960

Stepped-care models for cancer symptom management: a ... This review highlights the potential clinical and economic benefits of implementing stepped-care interventions to reduce the severity of cancer-related ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.e24191

A phase III randomized controlled trial of a stepped ... The aims of this study were to screen patients for symptoms of depression, pain, and/or fatigue and test the efficacy of a stepped collaborative care (SCC) ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673624000151

Patient, family caregiver, and economic outcomes of an ... Patients in the stepped collaborative care group had a greater 0–6-month improvement in health-related quality of life than patients in the standard-of-care ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02944136

Collaborative Care Intervention for Cancer Caregivers The proposed randomized controlled trial will test the efficacy of a stepped collaborative care intervention, versus enhanced usual care arm, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4828258/

A Web-based Collaborative Care Intervention to Manage ... The aim of the study was to examine the efficacy of a collaborative care intervention to reduce depression, pain and fatigue and improve quality of life.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421000318

The next generation of collaborative care We plan to test a web-based stepped collaborative care intervention with 450 cancer patients and 200 caregivers in the context of a randomized controlled trial.