Using Technology to Optimize Collaborative Care Management of Depression in Urban and Rural Cancer Centers, SCOPE
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 or focus groups regarding their experience with CoCM and the newly developed web-based platform. |
Other: Interview or Focus Group
Participate in interview or focus group
Other: Media/technology Intervention with collaborative care
Use t-CoCM digital platform with collaborative care
Other: Survey Administration
Complete surveys
|
| 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: Collaborative care
Receive u-CoCM
Other Names:
Other: Survey Administration
Complete surveys
|
Outcome Measures
Primary Outcome Measures
- Level of treatment engagement (collaboration & coordination of care) [Baseline to 9 months]
Follow-up contacts (in person, phone or video) documented in patient registry and electronic health record (her). 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 9 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 9 months]
Antidepressant treatment: Achieving therapeutic dose for at least 6 weeks. Dosage and adherence recorded in the patient registry aherEHR, 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.
- 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
- 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 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 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 Co-e 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 [Up to 12 months]
Usage logs and qualitative data gathered during interviews or focus groups
- Care Managers experience using the new technology [Up to 5 years]
Usage logs and qualitative data gathered during interviews or focus groups
- 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.
- Oncology provider's perception of patient's adherence to cancer treatment [After the patient has completed their involvement in the study (Up to 5 years)]
The patient's primary oncology provider will complete a standardized questionnaire to document delays or disruptions encountered in their planned cancer treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients receiving active treatment (surgery, chemotherapy [including immunotherapy or hormone therapy], radiation therapy) for a malignancy
-
= 18 years old
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Participants must be ambulatory for clinical care visits
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Clinically significant depression (Patient Health Questionnaire-9 (PHQ-9) >= 10 with at least one cardinal symptom > 1)
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Access to smartphone, tablet, or computer with internet access; to short message service (SMS); or landline
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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:
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Advanced cancer or other condition that limits remaining life expectancy to less than 9 months
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Collaborative care management of depression at the study cancer center is not indicated (e.g., patient is already engaged in or needing immediate specialty mental health care for bipolar disorder or schizophrenia, patient is no longer actively followed at the cancer center)
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Inability to speak and read English
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MultiCare Regional Cancer Center - Gig Harbor | Gig Harbor | Washington | United States | 98335 |
| 2 | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | United States | 98109 |
| 3 | MultiCare Regional Cancer Center - Tacoma | Tacoma | Washington | United States | 98405 |
Sponsors and Collaborators
- University of Washington
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Jesse R. Fann, Fred Hutch/University of Washington Cancer Consortium
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RG1121503
- NCI-2021-07762
- STUDY00012892
- R01CA244171