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

NCT ID: NCT05012124

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

297 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-15

Study Completion Date

2026-03-31

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.

Conditions

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Depression Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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 regarding their experience with CoCM and the newly developed web-based platform.

Group Type EXPERIMENTAL

Interview or Focus Group

Intervention Type OTHER

Participate in an interview or focus group

Media/technology Intervention with collaborative care

Intervention Type OTHER

Use t-CoCM digital platform with collaborative care

Survey Administration

Intervention Type OTHER

Complete surveys

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.

Group Type ACTIVE_COMPARATOR

Collaborative care

Intervention Type OTHER

Receive u-CoCM

Survey Administration

Intervention Type OTHER

Complete surveys

Interventions

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Collaborative care

Receive u-CoCM

Intervention Type OTHER

Interview or Focus Group

Participate in an interview or focus group

Intervention Type OTHER

Media/technology Intervention with collaborative care

Use t-CoCM digital platform with collaborative care

Intervention Type OTHER

Survey Administration

Complete surveys

Intervention Type OTHER

Other Intervention Names

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best practice standard of care standard therapy

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jesse R. Fann

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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MultiCare Regional Cancer Center - Auburn

Auburn, Washington, United States

Site Status

MultiCare Regional Cancer Center - Gig Harbor

Gig Harbor, Washington, United States

Site Status

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

MultiCare Regional Cancer Center - Tacoma

Tacoma, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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NCI-2021-07762

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00012892

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA244171

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RG1121503

Identifier Type: -

Identifier Source: org_study_id