Technology-Enhanced Care for Depression in Cancer Patients

(SCOPE-C Trial)

Not currently recruiting at 3 trial locations

Overseen By Jesse R. Fann

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Advanced cancer, Bipolar, Schizophrenia, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help cancer patients experiencing depression. It compares a digital approach, technology-enhanced collaborative care management (t-CoCM), with the usual care method to determine which better reduces depression symptoms. The t-CoCM approach uses apps and web tools to assist patients and care managers in managing mental health. People currently receiving cancer treatment and experiencing significant depression might be suitable candidates. Participants need internet or smartphone access, and support is available for those who need it. As an unphased trial, this study offers patients the chance to explore innovative care methods that could significantly improve their mental health.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that technology-enhanced collaborative care management is safe for cancer patients with depression?

Research shows that collaborative care management effectively supports patients with cancer and depression by integrating mental health care with regular medical care. Technology-enhanced Collaborative Care Management (t-CoCM) updates this approach by incorporating digital tools.

Studies have found that this method effectively combines care and supports patients' mental health. Although specific safety data remains limited, the collaborative care model has a strong history of being well-received. It complements the medical treatments patients already receive.

No major safety concerns have emerged regarding digital tools in these settings. The goal is to simplify and enhance accessibility in the care process without introducing extra risks. Overall, t-CoCM appears to be a safe way to manage depression in cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Technology-Enhanced Collaborative Care Management (t-CoCM) approach for treating depression in cancer patients because it leverages digital tools to enhance patient care. Unlike traditional treatments that rely solely on in-person consultations and standard care pathways, t-CoCM incorporates a digital app platform and a web-based registry to facilitate ongoing collaborative care. This tech-driven method aims to improve patient engagement and streamline communication between patients and care managers, potentially leading to better mental health outcomes. Additionally, the use of digital platforms allows for more comprehensive data collection and personalized care, which could revolutionize how depression is managed in cancer patients.

What evidence suggests that technology-enhanced collaborative care management is effective for reducing depression in cancer patients?

Research has shown that Collaborative Care Management (CoCM) effectively treats depression, even in patients with cancer. Behavioral Activation, a key component of CoCM, encourages activities that improve mood. This trial will compare two approaches: the usual CoCM, provided to participants in Arm II, and the technology-enhanced CoCM (t-CoCM), used by participants in Arm I. Studies suggest that incorporating technology into this approach can enhance its effectiveness by improving care management efficiency. Digital tools enable care managers to track progress and adjust treatments more swiftly, potentially leading to better outcomes for patients facing both cancer and depression. ^{1 2 3 6 7}

Who Is on the Research Team?

Jesse R. Fann

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for adults with clinically significant depression (PHQ-9 score >=10) who are undergoing active cancer treatment and can use a smartphone, tablet, or computer. It's not for those with advanced cancer limiting life expectancy to less than 9 months or individuals needing immediate specialty mental health care.

Inclusion Criteria

I can walk to my clinic appointments.

Clinically significant depression (Patient Health Questionnaire-9 (PHQ-9) >= 10 with at least one cardinal symptom > 1)

Access to smartphone, tablet, or computer with internet access; or landline

Exclusion Criteria

Inability to speak and read English

Already engaged in or needing immediate specialty mental health care e.g., for bipolar disorder or schizophrenia

My doctor expects I have less than 9 months to live due to my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either technology-enhanced collaborative care management (t-CoCM) or usual collaborative care management (u-CoCM) for depression during cancer treatment

12 months

Surveys at baseline, 3, 6, and 9 months; follow-up contacts documented

Follow-up

Participants are monitored for changes in depression severity, anxiety, functional status, and other health outcomes

12 months

Surveys and assessments at baseline, 3, 6, 9, and 12 months

Extension

Care managers and oncology providers participate in interviews or focus groups about their experience with the collaborative care management platforms

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Technology-enhanced Collaborative Care Management

Trial Overview The study compares technology-enhanced collaborative care management (t-CoCM) versus usual care in managing depression for cancer patients. t-CoCM integrates tech tools to help clinicians deliver behavioral treatments and monitor patient progress more effectively.

How Is the Trial Designed?

Group I: Arm I (t-CoCM) Experimental Treatment 3 Interventions

Patients use the t-CoCM digital app platform and clinic care managers use the t-CoCM web-based registry platform to support delivery of collaborative care. Patient's complete surveys at baseline, 3, 6 and 9 months. Some patients also participate in an interview or focus group about their user experience with the t-CoCM digital platform. Care managers also participate in interviews regarding their experience with CoCM and the newly developed web-based platform.

Group II: Arm II (u-CoCM) Active Control 2 Interventions

Patients receive usual care and clinic care managers deliver usual CoCM. Patients complete surveys at baseline, 3, 6 and 9 months.

Technology-enhanced Collaborative Care Management is already approved in United States, European Union for the following indications:

Approved in United States as Collaborative Care Model for:

• Depression in cancer patients
• Anxiety in cancer patients
• Pain management in cancer patients

Approved in European Union as Collaborative Care Model for:

• Depression in cancer patients
• Anxiety in cancer patients
• Psychosocial support in cancer care

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11176239

Project Details - NIH RePORTER The study will develop technology to optimize the delivery of an effective system of care for depression, called Collaborative Care Management. Improving the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05012124

Study Details | NCT05012124 | Using Technology to ... This study compares the effectiveness of technology-enhanced collaborative care management (t-CoCM) to usual collaborative care management (u-CoCM) in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12165027/

SCOPE: Examining Technology-Enhanced Collaborative ... Behavioral Activation is a core psychosocial component of collaborative care, effective for treating depression [31, 32], including in cancer patients [53, 55].

4. dl.acm.org dl.acm.org/doi/10.1145/3711060

SCOPE: Examining Technology-Enhanced Collaborative ... Collaborative care management is an evidence-based approach to integrated psychosocial care for patients with comorbid cancer and depression ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0163834322000330

Implementing collaborative care for major depression in a ... This observational study describes the implementation of a collaborative care program for major depression, developed specifically for patients attending cancer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7351346/

Parallel Journeys of Patients with Cancer and Depression Integrating psychosocial care into cancer services through the team-based Collaborative Care Management (CoCM) model has been proven to be effective in ...

7. mental.jmir.org mental.jmir.org/2022/2/e30810/

Digital and Mobile Health Technology in Collaborative ... This study aims to conduct a scoping review to synthesize the evidence available on digital and mobile health technology in collaborative care settings.