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

Using Technology to Optimize Collaborative Care Management of Depression in Urban and Rural Cancer Centers (AKA: SUPPORTING COLLABORATIVE CARE TO OPTIMIZE PSYCHOSOCIAL ENGAGEMENT IN THE CANCER SETTING [SCOPE])

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.

Study Overview

• Status: Terminated
• Conditions: Depression; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: Media/technology Intervention with collaborative care; Other: Collaborative care; Other: Interview or Focus Group

Detailed Description

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (t-CoCM): Patients use the t-CoCM digital app platform and clinic care managers use the t-CoCM web-based patient registry platform to support delivery of collaborative care. Patients 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 or focus groups regarding their experience with CoCM and the newly developed web-based platform.

ARM II (u-CoCM): Patients receive usual care and clinic care managers deliver usual CoCM. Patients complete surveys at baseline, 3, 6 and 9 months.

• Study Type: Interventional
• Enrollment (Actual): 297
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Auburn, Washington, United States, 98002
      • MultiCare Regional Cancer Center - Auburn
    • Gig Harbor, Washington, United States, 98335
      • MultiCare Regional Cancer Center - Gig Harbor
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium
    • Tacoma, Washington, United States, 98405
      • MultiCare Regional Cancer Center - Tacoma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm II (u-CoCM); Patients receive usual care and clinic care managers deliver usual CoCM. Patients complete surveys at baseline, 3, 6 and 9 months.	Other: Survey Administration; Complete surveys; Other: Collaborative care; Receive u-CoCM; Other Names: standard of care; standard therapy; best practice
Experimental: Arm I (t-CoCM); 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: Survey Administration; Complete surveys; Other: Media/technology Intervention with collaborative care; Use t-CoCM digital platform with collaborative care; Other: Interview or Focus Group; Participate in an interview or focus group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient-centered shared decision-making score	The 9-item Shared Decision-Making Questionnaire (SDM-Q-9) will be adapted and administered.	3, 6, and 9 months
Change in anxiety severity	The SCL-10 contains the 10 items from the SCL-90 that relate specifically to anxiety symptoms.	Baseline, 3, 6, and 9 months
Change in functional status	The Sheehan Disability Scale (SDS) was developed to assess functional impairment in three inter-related domains; work/school, social, and family life.	Baseline, 3, 6, and 9 months
Change in patient impression of change and satisfaction with care	The Patient's Global Impression of Change (PGIC) and satisfaction with care (7- point Likert) scales.	3, 6, and 9 months
Change in health services utilization	Cornell Services Index (CSI), measures the quantity and characteristics of health services used in the past 3 months.	Baseline, 3, 6, and 9 months
Change in Alcohol, Smoking, and Substance Use	Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) documents psychoactive substance use and related problems in patients.	Baseline and 6 months
Change in Daily Alcohol Use	Daily Drinking Questionnaire (DDQ) measures the quantity and frequency of participant's alcohol use.	Baseline and 6 months
Change in Cannabis Use	Self-report survey about patient's reasons, routes of administration, and frequency of cannabis use.	Baseline, 3, 6, and 9 months
Change in Use of Complementary and Alternative Therapy Use	Self-report survey about patient's recent use of complementary and alternative therapies.	Baseline and 6 months
Care manager (CM) satisfaction with Collaborative Care Management (CoCM) of depression	Measures CM satisfaction with implementation of CoCM.	At the end of the study or when a Care Manager leaves their role (Up to 5 years)
Change in health-related quality of life global scales and subscales	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 - Functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), global health status and quality of life scale, also several single-item symptom measures.	Baseline, 3, 6, and 9 months
Change in environmental reward score	Environmental Reward Observation Scale (EROS) measures self-rated environmental reward and response-contingent positive reinforcement.	Baseline and 6 months
Change in Instrumental Support: patient's perception of available support	NIH Toolbox Instrumental Support Survey measures patient's perceived availability of people who can provide functional aid to help them complete daily tasks.	Baseline and 6 months
Patient's experience using the new technology	Self reported survey; and for a subset of participants, an interview or focus group	Survey: 6 Months; Interview/focus group: between 6-12 months
Care Managers experience using the new technology	Interview or focus group of care managers	Up to 5 years
Oncology provider's perception of patient's adherence to cancer treatment	The patient's primary oncology provider will complete a standardized questionnaire to report delays or disruptions encountered in their planned cancer treatment.	After the patient is sent their 9 Month survey. Oncologists may participate on behalf of multiple patients for a period of up to 3 years)
Change in patient-reported depression severity	Self-report Patient Health Questionnaire (PHQ-9) collected from patient registry and patient medical records.	Baseline to 12 months
Change in patient-reported anxiety severity	Self-report Generalized Anxiety Disorder questionnaire (GAD-7) collected from patient registry and patient medical records.	Baseline to 12 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jesse R. Fann, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Actual): October 28, 2025
• Study Completion (Actual): March 31, 2026

Study Registration Dates

• First Submitted: August 11, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Behavioral Symptoms; Hematologic Diseases; Behavior; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Depression; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Chemical Actions and Uses; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Quality Indicators, Health Care; Equipment and Supplies; Specialty Uses of Chemicals; Guidelines as Topic; Quality Assurance, Health Care; Laboratory Chemicals; Interviews as Topic; Standard of Care; Practice Guidelines as Topic; Focus Groups; Culture Media
• Other Study ID Numbers: RG1121503; NCI-2021-07762 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); STUDY00012892 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); R01CA244171 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No