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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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])

Conditions
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Depression, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
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* Other: Collaborative care
* Other: Interview or Focus Group
* Other: Media/technology Intervention with collaborative care
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. 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 | 
| 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 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 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 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 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 | 
| 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 | 
| 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 | 
| 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) | 
| 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) |