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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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Study closed to accrual before meeting accrual goal due to enrollment challenges and end of funding.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (t-CoCM) | Experimental | 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. |
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| Arm II (u-CoCM) | Active Comparator | Patients receive usual care and clinic care managers deliver usual CoCM. Patients complete surveys at baseline, 3, 6 and 9 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collaborative care | Other | Receive u-CoCM |
|
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| 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. | 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 |
| 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 |
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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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesse R. Fann | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MultiCare Regional Cancer Center - Auburn | Auburn | Washington | 98002 | United States | ||
| MultiCare Regional Cancer Center - Gig Harbor |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 4, 2022 | Apr 16, 2025 |
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| Interview or Focus Group | Other | Participate in an interview or focus group |
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| Media/technology Intervention with collaborative care | Other | Use t-CoCM digital platform with collaborative care |
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| Survey Administration | Other | Complete surveys |
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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 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 |
| 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) |
| Gig Harbor |
| Washington |
| 98335 |
| United States |
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| MultiCare Regional Cancer Center - Tacoma | Tacoma | Washington | 98405 | United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D003863 | Depression |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D007407 | Interviews as Topic |
| D017144 | Focus Groups |
| D003470 | Culture Media |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D019995 | Laboratory Chemicals |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D004864 | Equipment and Supplies |
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