Technology-Enhanced Care for Depression in Cancer Patients

(SCOPE-C Trial)

Recruiting at 3 trial locations

Overseen by Jesse R. Fann

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Washington

Disqualifiers: Advanced cancer, Bipolar, Schizophrenia, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study compares the effectiveness of technology-enhanced collaborative care management (t-CoCM) to usual collaborative care management (u-CoCM) in achieving fidelity to processes of care and reducing depression symptoms in patients currently receiving cancer treatment. CoCM is a population-based, integrated care approach, where care managers, who are clinicians (typically clinical social workers), deliver behavioral treatments, coordinate psychosocial care, monitor outcomes, and adjust treatment with the input of a psychiatric consultant. The use of t-CoCM may improve the treatment of depression and improve patient outcomes and quality of life.

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 data supports the effectiveness of the treatment Technology-enhanced Collaborative Care Management for depression in cancer patients?

Research shows that the Collaborative Care Model (CoCM) is effective for managing depression in primary care settings and has been adapted for cancer patients. The 'Depression Care for People with Cancer' intervention, an extended form of CoCM, has been integrated into cancer services and evaluated in trials, showing promise in managing depression for cancer patients. ^{1 2 3 4 5}

Is the Technology-Enhanced Care for Depression in Cancer Patients safe for humans?

The Collaborative Care Model (CoCM), which is similar to Technology-Enhanced Care, has been widely used for depression and anxiety in primary care settings and is generally considered safe. There is no specific mention of safety concerns in the studies reviewed, suggesting it is safe for human use. ^{2 3 6 7 8}

How is the Technology-enhanced Collaborative Care Management treatment different from other treatments for depression in cancer patients?

Technology-enhanced Collaborative Care Management (t-CoCM) is unique because it integrates technology to enhance the collaborative care model, which involves a care manager coordinating depression treatment with both the patient's primary care doctor and cancer team, under the supervision of a psychiatrist. This approach is designed to be more comprehensive and tailored to the needs of cancer patients compared to standard depression treatments. ^{1 5 9 10 11}

Research Team

Jesse R. Fann

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Technology-enhanced Collaborative Care Management (Behavioural Intervention)

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.

Participant Groups

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.

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+

Findings from Research

The 'Depression Care for People with Cancer' (DCPC) program is designed to improve depression management for cancer patients by integrating care into existing cancer services, highlighting the need for better support in this population.

DCPC utilizes a collaborative care model where a care manager, supervised by a psychiatrist, coordinates treatment and communication between the patient's primary care physician and cancer team, aiming to enhance the overall management of depression in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression Care for People with Cancer: a collaborative care intervention. Walker, J., Sharpe, M.[2022]

A study involving 80 primary care patients referred to a Collaborative Care Model (CoCM) for anxiety and depression revealed that many declined participation due to uncertainty about insurance coverage, lack of understanding of the program, and feelings that the services were unnecessary.

Qualitative interviews identified 23 barriers to enrollment, including mental health stigma, prioritization of physical health, and concerns about the use of mental health information, highlighting the need for improved communication and relationship-building between patients and their primary care clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation Barriers and Experiences of Eligible Patients Who Failed to Enroll in Collaborative Care for Depression and Anxiety. Fu, E., Carroll, AJ., Rosenthal, LJ., et al.[2023]

The study is evaluating the effectiveness and implementation of the Collaborative Behavioral Health Program (CBHP) in 11 primary care practices over a 30-month period, aiming to improve access to mental health services for depression.

It will provide insights into the barriers and facilitators of implementing the Collaborative Care Model (CoCM) and conduct economic analyses to assess the cost-effectiveness of the program, potentially benefiting both mental health outcomes and chronic health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative care for depression management in primary care: A randomized roll-out trial using a type 2 hybrid effectiveness-implementation design. Smith, JD., Fu, E., Rado, J., et al.[2022]

In a study of 5,439 patients using the collaborative care model (CCM), having a follow-up contact with a care manager within four weeks significantly increased the likelihood of improvement in depression symptoms (odds ratio of 1.63).

Receiving a psychiatric consultation between weeks 8 and 12 also improved the chances of symptom improvement (odds ratio of 1.44), highlighting the importance of these care tasks in enhancing patient outcomes in depression treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unpacking Collaborative Care for Depression: Examining Two Essential Tasks for Implementation. Bao, Y., Druss, BG., Jung, HY., et al.[2023]

The COPE-D intervention significantly improved depression and quality of life for underserved cancer patients, with 65% of participants showing treatment improvement and 56% achieving a significant treatment response.

Outcomes such as suicidal ideation, anxiety, sleep disturbance, and social isolation also improved, indicating the intervention's broad effectiveness across various mental health aspects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative depression care sensitive to the needs of underserved patients with cancer: Feasibility, acceptability and outcomes. Price, S., Hamann, HA., Halaby, L., et al.[2023]

The collaborative care management (CoCM) model can be successfully adapted for use in a low-barrier HIV clinic, which serves a complex patient population with high levels of mental illness and substance use, demonstrating its flexibility beyond traditional primary care settings.

Despite the need for significant adaptations to fit the unique context of the HIV clinic, the core structural elements of CoCM were preserved, indicating that effective behavioral health integration can be achieved even in nonconventional healthcare environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of the collaborative care model to integrate behavioral health care into a low-barrier HIV clinic. Dombrowski, JC., Halliday, S., Tsui, JI., et al.[2023]

The implementation of an app-augmented collaborative care model (CoCM) in a diverse patient population led to significantly more healthcare team contacts and quicker follow-up times compared to standard CoCM, indicating improved patient engagement in treatment.

Patients using the app showed similar clinical outcomes in depression improvement as those in standard CoCM, but with higher appointment compliance and fewer missed appointments, suggesting that technology can enhance the effectiveness and sustainability of behavioral health care in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the scalability of the collaborative care model for depression using mobile technology. Carleton, KE., Patel, UB., Stein, D., et al.[2021]

In a study of 132 patients in prolonged collaborative care management (CCM) for depression, factors such as being unmarried, having dysthymia, and severe depression were significant predictors of prolonged treatment needs, indicating that these characteristics may help identify patients who might not respond well to CCM.

The study found that patients in prolonged care management had significantly higher depression scores (PHQ-9) compared to those who achieved remission within 6 months, suggesting that monitoring PHQ-9 scores over time could help differentiate between patients who will benefit from CCM and those who may require alternative treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged care management for depression: a case-controlled study of those enrolled for more than one year. Angstman, KB., Pecina, JL., Bernard, ME., et al.[2014]

The SMaRT Oncology-2 Trial will evaluate the effectiveness and cost-effectiveness of 'Depression Care for People with Cancer' in 500 patients with cancer and major depressive disorder, building on previous findings that showed improved depression outcomes compared to usual care alone.

The primary goal is to determine if this specialized depression care can achieve a 50% reduction in depression scores after 24 weeks, while also assessing its impact on patients' quality of life and overall cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The second Symptom Management Research Trial in Oncology (SMaRT Oncology-2): a randomised trial to determine the effectiveness and cost-effectiveness of adding a complex intervention for major depressive disorder to usual care for cancer patients. Walker, J., Cassidy, J., Sharpe, M.[2021]

A collaborative care program for treating major depression in cancer patients was successfully implemented in routine outpatient care, with 90% of patients participating in screening and 61% attending at least one treatment session.

The program demonstrated effective depression outcomes, achieving a treatment response rate similar to clinical trial benchmarks, highlighting its potential as a valuable component of cancer care despite initial implementation challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing collaborative care for major depression in a cancer center: An observational study using mixed-methods. Walker, J., Hobbs, H., Wanat, M., et al.[2022]

The IMPACT program significantly improved depressive symptoms in older cancer patients, with 55% of participants showing a 50% or greater reduction in symptoms at 6 months compared to 34% in usual care.

Patients in the IMPACT program also experienced better outcomes in terms of remission rates, quality of life, and functional impairment, demonstrating its effectiveness in managing depression in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving primary care for older adults with cancer and depression. Fann, JR., Fan, MY., Unützer, J.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Depression Care for People with Cancer: a collaborative care intervention. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Implementation Barriers and Experiences of Eligible Patients Who Failed to Enroll in Collaborative Care for Depression and Anxiety. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Collaborative care for depression management in primary care: A randomized roll-out trial using a type 2 hybrid effectiveness-implementation design. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Unpacking Collaborative Care for Depression: Examining Two Essential Tasks for Implementation. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Collaborative depression care sensitive to the needs of underserved patients with cancer: Feasibility, acceptability and outcomes. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Adaptation of the collaborative care model to integrate behavioral health care into a low-barrier HIV clinic. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Enhancing the scalability of the collaborative care model for depression using mobile technology. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Prolonged care management for depression: a case-controlled study of those enrolled for more than one year. [2014]

9. England pubmed.ncbi.nlm.nih.gov

The second Symptom Management Research Trial in Oncology (SMaRT Oncology-2): a randomised trial to determine the effectiveness and cost-effectiveness of adding a complex intervention for major depressive disorder to usual care for cancer patients. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Implementing collaborative care for major depression in a cancer center: An observational study using mixed-methods. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Improving primary care for older adults with cancer and depression. [2022]