DepressionNCT05012124
Using Technology to Optimize Collaborative Care Management of Depression in Urban and Rural Cancer Centers, SCOPE
A study testing Collaborative care, Interview or Focus Group and Media/technology Intervention with collaborative care in people with Depression and Hematopoietic and Lymphoid Cell Neoplasm, run by University of Washington at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Collaborative care, Interview or Focus Group and Media/technology Intervention with collaborative care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Apr 2022to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
MultiCare Regional Cancer Center - Auburn
Auburn, Washington, 98002
MultiCare Regional Cancer Center - Gig Harbor
Gig Harbor, Washington, 98335
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
MultiCare Regional Cancer Center - Tacoma
Tacoma, Washington, 98405
About this study
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])
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.
Read the 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.
- Being tested
- Collaborative care, Interview or Focus Group, Media/technology Intervention with collaborative care, Survey Administration
- Medical subject headings
- Depression, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative careOther
Also called best practice, standard of care, standard therapy
Receive u-CoCM
Interview or Focus GroupOther
Participate in an interview or focus group
Media/technology Intervention with collaborative careOther
Use t-CoCM digital platform with collaborative care
Survey AdministrationOther
Complete surveys
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interview or Focus Group; Other: Media/technology Intervention with collaborative care; Other: Survey Administration |
| 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. Receives: Other: Collaborative care; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3, 6, and 9 months
Secondary outcomes (18)
Change in patient-centered shared decision-making score
The 9-item Shared Decision-Making Questionnaire (SDM-Q-9) will be adapted and administered.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 6 months
Change in Daily Alcohol Use
Daily Drinking Questionnaire (DDQ) measures the quantity and frequency of participant's alcohol use.
Measured: Baseline and 6 months
Change in Cannabis Use
Self-report survey about patient's reasons, routes of administration, and frequency of cannabis use.
Measured: 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.
Measured: 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
Measured: Survey: 6 Months; Interview/focus group: between 6-12 months
Care Managers experience using the new technology
Interview or focus group of care managers
Measured: Up to 5 years
Care manager (CM) satisfaction with Collaborative Care Management (CoCM) of depression
Measures CM satisfaction with implementation of CoCM.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start15 Apr 2022
- Primary completion28 Oct 2025
- Study completion31 Mar 2026
Why it stopped: Study closed to accrual before meeting accrual goal due to enrollment challenges and end of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jesse Fann, University of Washington
- Investigators
- Jesse R. Fann, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012124
- Sponsor's protocol ID
- RG1121503
- Other IDs
- NCI-2021-07762, STUDY00012892, R01CA244171
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2021
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fann JR, Lostutter TW, Andris L, Bates N, Rhew IC, Bauer AM, Bennett IM, Martin D, Irwin B, Powers DM, Cruz J, Hsieh G, Fogarty J. Technology-enabled collaborative care management of depression in urban and rural cancer centers: Protocol and baseline results from the SCOPE pragmatic hybrid effectiveness-implementation trial. Contemp Clin Trials. 2026 Sep;168:108409. doi: 10.1016/j.cct.2026.108409. Epub 2026 Jul 21.
PubMed 42480863
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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])
- ClinicalTrials.gov ID
- NCT05012124
- Acronym / sponsor ID
- RG1121503
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed to accrual before meeting accrual goal due to enrollment challenges and end of funding.
- Enrolment
- 297 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (t-CoCM) | Experimental | Other: Interview or Focus Group, Other: Media/technology Intervention with collaborative care, Other: Survey AdministrationPatients 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. |
| Arm II (u-CoCM) | Active comparator | Other: Collaborative care, Other: Survey AdministrationPatients receive usual care and clinic care managers deliver usual CoCM. Patients complete surveys at baseline, 3, 6 and 9 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative careAlso: best practice, standard of care, standard therapyReceive u-CoCM | Other | Arm II (u-CoCM) |
| Interview or Focus GroupParticipate in an interview or focus group | Other | Arm I (t-CoCM) |
| Media/technology Intervention with collaborative careUse t-CoCM digital platform with collaborative care | Other | Arm I (t-CoCM) |
| Survey AdministrationComplete surveys | Other | Arm I (t-CoCM), Arm II (u-CoCM) |
Primary outcome
Level of treatment engagement (collaboration & coordination of care)
Time frame: Baseline to 12 months
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.
Use of depression patient-reported outcomes for measurement-based care
Time frame: Baseline to 12 months
Patient-reported depression measure (PHQ-9) score collected (in person or remotely) and entered into patient registry.
Adherence to guideline-level depression treatment
Time frame: Baseline to 12 months
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.
Change in depression severity
Time frame: 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.
18 secondary outcomes
Change in patient-centered shared decision-making score
Time frame: 3, 6, and 9 months
Change in anxiety severity
Time frame: Baseline, 3, 6, and 9 months
Change in patient-reported depression severity
Time frame: Baseline to 12 months
Change in patient-reported anxiety severity
Time frame: Baseline to 12 months
Change in health-related quality of life global scales and subscales
Time frame: Baseline, 3, 6, and 9 months
Change in functional status
Time frame: Baseline, 3, 6, and 9 months
Change in patient impression of change and satisfaction with care
Time frame: 3, 6, and 9 months
Change in health services utilization
Time frame: Baseline, 3, 6, and 9 months
Change in environmental reward score
Time frame: Baseline and 6 months
Change in Instrumental Support: patient's perception of available support
Time frame: Baseline and 6 months
Change in Alcohol, Smoking, and Substance Use
Time frame: Baseline and 6 months
Change in Daily Alcohol Use
Time frame: Baseline and 6 months
Change in Cannabis Use
Time frame: Baseline, 3, 6, and 9 months
Change in Use of Complementary and Alternative Therapy Use
Time frame: Baseline and 6 months
Patient's experience using the new technology
Time frame: Survey: 6 Months; Interview/focus group: between 6-12 months
Care Managers experience using the new technology
Time frame: Up to 5 years
Care manager (CM) satisfaction with Collaborative Care Management (CoCM) of depression
Time frame: 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
Time frame: 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)
Results and safety
The study was stopped early (reason given: Study closed to accrual before meeting accrual goal due to enrollment challenges and end of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Derived from this study: PubMed 42480863Fann JR, Lostutter TW, Andris L, Bates N, Rhew IC, Bauer AM, Bennett IM, Martin D, Irwin B, Powers DM, Cruz J, Hsieh G, Fogarty J. Technology-enabled collaborative care management of depression in urban and rural cancer centers: Protocol and baseline results from the SCOPE pragmatic hybrid effectiveness-implementation trial. Contemp Clin Trials. 2026 Sep;168:108409. doi: 10.1016/j.cct.2026.108409. Epub 2026 Jul 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesse R. Fann principal investigator
Fred Hutch/University of Washington Cancer Consortium
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative care, Interview or Focus Group and Media/technology Intervention with collaborative care in people with Depression and Hematopoietic and Lymphoid Cell Neoplasm, run by University of Washington at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study closed to accrual before meeting accrual goal due to enrollment challenges and end of funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of treatment engagement (collaboration & coordination of care) (time frame: Baseline to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05012124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.