Clinical trial NCT05012124: Using Technology to Optimize Collaborative Care Management of Depression in Urban and Rural Cancer Centers, SCOPE
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])
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-08-19
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of treatment engagement (collaboration & coordination of care)
timeFrame: Baseline to 12 months
measure: Use of depression patient-reported outcomes for measurement-based care
timeFrame: Baseline to 12 months
measure: Adherence to guideline-level depression treatment
timeFrame: Baseline to 12 months
measure: Change in depression severity
timeFrame: Baseline, 3, 6, and 9 months
Secondary outcomes:
measure: Change in patient-centered shared decision-making score
timeFrame: 3, 6, and 9 months
measure: Change in anxiety severity
timeFrame: Baseline, 3, 6, and 9 months
measure: Change in patient-reported depression severity
timeFrame: Baseline to 12 months
measure: Change in patient-reported anxiety severity
timeFrame: Baseline to 12 months
measure: Change in health-related quality of life global scales and subscales
timeFrame: Baseline, 3, 6, and 9 months
measure: Change in functional status
timeFrame: Baseline, 3, 6, and 9 months
measure: Change in patient impression of change and satisfaction with care
timeFrame: 3, 6, and 9 months
measure: Change in health services utilization
timeFrame: Baseline, 3, 6, and 9 months
measure: Change in environmental reward score
timeFrame: Baseline and 6 months
measure: Change in Instrumental Support: patient's perception of available support
timeFrame: Baseline and 6 months
measure: Change in Alcohol, Smoking, and Substance Use
timeFrame: Baseline and 6 months
measure: Change in Daily Alcohol Use
timeFrame: Baseline and 6 months
measure: Change in Cannabis Use
timeFrame: Baseline, 3, 6, and 9 months
measure: Change in Use of Complementary and Alternative Therapy Use
timeFrame: Baseline and 6 months
measure: Patient's experience using the new technology
timeFrame: Survey: 6 Months; Interview/focus group: between 6-12 months
measure: Care Managers experience using the new technology
timeFrame: Up to 5 years
measure: Care manager (CM) satisfaction with Collaborative Care Management (CoCM) of depression
timeFrame: At the end of the study or when a Care Manager leaves their role (Up to 5 years)
measure: Oncology provider's perception of patient's adherence to cancer treatment
timeFrame: 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)
Other outcomes:
Locations:
city: Auburn
country: United States
facility: MultiCare Regional Cancer Center - Auburn
state: Washington
city: Gig Harbor
country: United States
facility: MultiCare Regional Cancer Center - Gig Harbor
state: Washington
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
city: Tacoma
country: United States
facility: MultiCare Regional Cancer Center - Tacoma
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Jesse R. Fann
role: PRINCIPAL_INVESTIGATOR
References: