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

Depression Clinical Trial

Official title:

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])

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05012124
• Other study ID #: RG1121503
• Secondary ID: NCI-2021-07762ST
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: February 2024
• Source: University of Washington
• Contact: Jesse R. Fann
• Phone: 206-685-4280
• Email: fann[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: March 31, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Other:
• Collaborative care
Receive u-CoCM
• Interview or Focus Group
Participate in an interview or focus group
• Media/technology Intervention with collaborative care
Use t-CoCM digital platform with collaborative care
• Survey Administration
Complete surveys

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.; Behavioral Activation (BA): Completion of key components of BA. BA adherence assessed by audiotaping and rating up to 10% of sessions using a fidelity checklist, as well as collecting usage logs from BA components of the digital platform in the t-CoCM arm.	Baseline to 12 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in environmental reward score	Environmental Reward Observation Scale (EROS) measures self-rated environmental reward and response-contingent positive reinforcement.	Baseline and 6 months
Secondary	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
Secondary	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
Secondary	Change in Daily Alcohol Use	Daily Drinking Questionnaire (DDQ) measures the quantity and frequency of participant's alcohol use.	Baseline and 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Care Managers experience using the new technology	Interview or focus group of care managers	Up to 5 years
Secondary	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)
Secondary	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)