Using Technology to Optimize Collaborative Care Management of Depression in Urban and Rural Cancer Centers, SCOPE

NCT05012124 | Terminated DMC

• 4 other identifiers: RG1121503NCI-2021-07762STUDY00012892R01CA244171
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Depression; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (4)

• Level of treatment engagement (collaboration & coordination of care)

  Follow-up contacts (in person, phone or video) documented in patient registry and electronic health record (EHR). Case reviews with consulting study psychiatrist. Total time spent interacting with patients documented by the care manager in the patient registry.

  Baseline to 12 months

• Use of depression patient-reported outcomes for measurement-based care

  Patient-reported depression measure (PHQ-9) score collected (in person or remotely) and entered into patient registry.

  Baseline to 12 months

• Adherence to guideline-level depression treatment

  Antidepressant treatment: Achieving therapeutic dose for at least 6 weeks. Dosage and adherence recorded in the patient registry and EHR, and self-reported medication data requested at 3, 6, and 9 month outcome assessments.

  Baseline to 12 months

• Change in depression severity

  The Symptom Checklist (SCL)-20 depression scale contains the 20 items from the SCL-90 that relate specifically to depressive symptoms.

  Baseline, 3, 6, and 9 months

Secondary Outcomes (18)

• Change in patient-centered shared decision-making score

  3, 6, and 9 months

• Change in anxiety severity

  Baseline, 3, 6, and 9 months

• Change in patient-reported depression severity

  Baseline to 12 months

• Change in patient-reported anxiety severity

  Baseline to 12 months

• Change in health-related quality of life global scales and subscales

  Baseline, 3, 6, and 9 months

Study Arms (2)

Arm I (t-CoCM)

EXPERIMENTAL

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.

Other: Interview or Focus Group; Other: Media/technology Intervention with collaborative care; Other: Survey Administration

Arm II (u-CoCM)

ACTIVE COMPARATOR

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

Other: Collaborative care; Other: Survey Administration

Interventions

Collaborative care OTHER

Receive u-CoCM

Also known as: best practice, standard of care, standard therapy

Arm II (u-CoCM)

Interview or Focus Group OTHER

Participate in an interview or focus group

Arm I (t-CoCM)

Survey Administration OTHER

Complete surveys

Arm I (t-CoCM); Arm II (u-CoCM)

Media/technology Intervention with collaborative care OTHER

Use t-CoCM digital platform with collaborative care

Arm I (t-CoCM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients receiving active treatment (surgery, chemotherapy, immunotherapy, targeted therapy, stem cell transplant, hormone therapy, radiation therapy) for a malignancy
• \>= 18 years old
• Participants must be ambulatory for clinical care visits
• 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
• Patients who do not have a smartphone will be offered assistance in obtaining a free smartphone through the government-sponsored Lifeline Phone Program for low-resourced individuals

You may not qualify if:

• Advanced cancer or other condition that limits remaining life expectancy to less than 9 months
• Already engaged in or needing immediate specialty mental health care e.g., for bipolar disorder or schizophrenia
• Inability to speak and read English

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

MultiCare Regional Cancer Center - Auburn

Auburn, Washington, 98002, United States

Location

MultiCare Regional Cancer Center - Gig Harbor

Gig Harbor, Washington, 98335, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MultiCare Regional Cancer Center - Tacoma

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Depression; Hematologic Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Interviews as Topic; Focus Groups; Culture Media

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health; Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses; Equipment and Supplies

Study Officials

• Jesse R. Fann

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 19, 2021
• Study Start: April 15, 2022
• Primary Completion: October 28, 2025
• Study Completion: March 31, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)