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

Not Applicable

Recruiting

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

• Registration Number: NCT05012124
• Lead Sponsor: University of Washington

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.

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 Timeline

• Study First Submitted: 2021-08-11
• Study First Submitted QC: 2021-08-11
• Study First Posted: 2021-08-19
• Study Start: 2022-04-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-11
• Primary Completion: 2025-09-30
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 390

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (u-CoCM)	Collaborative care	Patients receive usual care and clinic care managers deliver usual CoCM. Patients complete surveys at baseline, 3, 6 and 9 months.
Arm I (t-CoCM)	Interview or Focus Group	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.
Arm II (u-CoCM)	Survey Administration	Patients receive usual care and clinic care managers deliver usual CoCM. Patients complete surveys at baseline, 3, 6 and 9 months.
Arm I (t-CoCM)	Media/technology Intervention with collaborative care	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.
Arm I (t-CoCM)	Survey Administration	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.

Primary Outcome Measures

Name	Time	Method
Level of treatment engagement (collaboration & coordination of care)	Baseline to 12 months	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.
Use of depression patient-reported outcomes for measurement-based care	Baseline to 12 months	Patient-reported depression measure (PHQ-9) score collected (in person or remotely) and entered into patient registry.
Adherence to guideline-level depression treatment	Baseline to 12 months	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.
Change in depression severity	Baseline, 3, 6, and 9 months	The Symptom Checklist (SCL)-20 depression scale contains the 20 items from the SCL-90 that relate specifically to depressive symptoms.

Secondary Outcome Measures

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

Trial Locations

Locations (4)

MultiCare Regional Cancer Center - Auburn; 🇺🇸 Auburn, Washington, United States

MultiCare Regional Cancer Center - Gig Harbor; 🇺🇸 Gig Harbor, Washington, United States

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States

MultiCare Regional Cancer Center - Tacoma; 🇺🇸 Tacoma, Washington, United States