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

Primary Purpose

Depression, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative care
Interview or Focus Group
Media/technology Intervention with collaborative care
Survey Administration
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients receiving active treatment (surgery, chemotherapy [including immunotherapy or 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; to short message service (SMS); 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
  • 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)
  • Inability to speak and read English

Sites / Locations

  • MultiCare Regional Cancer Center - Gig HarborRecruiting
  • Fred Hutch/University of Washington Cancer ConsortiumRecruiting
  • MultiCare Regional Cancer Center - TacomaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (t-CoCM)

Arm II (u-CoCM)

Arm Description

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.

Patients receive usual care and clinic care managers deliver usual CoCM. Patients complete surveys at baseline, 3, 6 and 9 months.

Outcomes

Primary Outcome Measures

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.
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.
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. 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
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
The 9-item Shared Decision-Making Questionnaire (SDM-Q-9) will be adapted and administered.
Change in anxiety severity
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
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.
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.
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.
Change in health services utilization
Cornell Services Index (CSI), measures the quantity and characteristics of health services used in the past 3 months.
Change in environmental reward score
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
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
Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) documents psychoactive substance use and related problems in patients.
Change in Daily Alcohol Use
Daily Drinking Questionnaire (DDQ) measures the quantity and frequency of participant's alcohol use.
Change in Cannabis Use
Self-report survey about patient's reasons, routes of administration, and frequency of cannabis use.
Change in Use of Complementary and Alternative Therapy Use
Self-report survey about patient's recent use of complementary and alternative therapies.
Patient's experience using the new technology
Self reported survey; and for a subset of participants, an interview or focus group
Care Managers experience using the new technology
Interview or focus group of care managers
Care manager (CM) satisfaction with Collaborative Care Management (CoCM) of depression
Measures CM satisfaction with implementation of CoCM.
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.

Full Information

First Posted
August 11, 2021
Last Updated
August 29, 2023
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05012124
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (t-CoCM)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II (u-CoCM)
Arm Type
Active Comparator
Arm Description
Patients receive usual care and clinic care managers deliver usual CoCM. Patients complete surveys at baseline, 3, 6 and 9 months.
Intervention Type
Other
Intervention Name(s)
Collaborative care
Other Intervention Name(s)
best practice, standard of care, standard therapy
Intervention Description
Receive u-CoCM
Intervention Type
Other
Intervention Name(s)
Interview or Focus Group
Intervention Description
Participate in an interview or focus group
Intervention Type
Other
Intervention Name(s)
Media/technology Intervention with collaborative care
Intervention Description
Use t-CoCM digital platform with collaborative care
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Complete surveys
Primary Outcome Measure Information:
Title
Level of treatment engagement (collaboration & coordination of care)
Description
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.
Time Frame
Baseline to 12 months
Title
Use of depression patient-reported outcomes for measurement-based care
Description
Patient-reported depression measure (PHQ-9) score collected (in person or remotely) and entered into patient registry.
Time Frame
Baseline to 12 months
Title
Adherence to guideline-level depression treatment
Description
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. 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.
Time Frame
Baseline to 12 months
Title
Change in depression severity
Description
The Symptom Checklist (SCL)-20 depression scale contains the 20 items from the SCL-90 that relate specifically to depressive symptoms.
Time Frame
Baseline, 3, 6, and 9 months
Secondary Outcome Measure Information:
Title
Change in patient-centered shared decision-making score
Description
The 9-item Shared Decision-Making Questionnaire (SDM-Q-9) will be adapted and administered.
Time Frame
3, 6, and 9 months
Title
Change in anxiety severity
Description
The SCL-10 contains the 10 items from the SCL-90 that relate specifically to anxiety symptoms.
Time Frame
Baseline, 3, 6, and 9 months
Title
Change in health-related quality of life global scales and subscales
Description
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.
Time Frame
Baseline, 3, 6, and 9 months
Title
Change in functional status
Description
The Sheehan Disability Scale (SDS) was developed to assess functional impairment in three inter-related domains; work/school, social, and family life.
Time Frame
Baseline, 3, 6, and 9 months
Title
Change in patient impression of change and satisfaction with care
Description
The Patient's Global Impression of Change (PGIC) and satisfaction with care (7- point Likert) scales.
Time Frame
3, 6, and 9 months
Title
Change in health services utilization
Description
Cornell Services Index (CSI), measures the quantity and characteristics of health services used in the past 3 months.
Time Frame
Baseline, 3, 6, and 9 months
Title
Change in environmental reward score
Description
Environmental Reward Observation Scale (EROS) measures self-rated environmental reward and response-contingent positive reinforcement.
Time Frame
Baseline and 6 months
Title
Change in Instrumental Support: patient's perception of available support
Description
NIH Toolbox Instrumental Support Survey measures patient's perceived availability of people who can provide functional aid to help them complete daily tasks.
Time Frame
Baseline and 6 months
Title
Change in Alcohol, Smoking, and Substance Use
Description
Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) documents psychoactive substance use and related problems in patients.
Time Frame
Baseline and 6 months
Title
Change in Daily Alcohol Use
Description
Daily Drinking Questionnaire (DDQ) measures the quantity and frequency of participant's alcohol use.
Time Frame
Baseline and 6 months
Title
Change in Cannabis Use
Description
Self-report survey about patient's reasons, routes of administration, and frequency of cannabis use.
Time Frame
Baseline, 3, 6, and 9 months
Title
Change in Use of Complementary and Alternative Therapy Use
Description
Self-report survey about patient's recent use of complementary and alternative therapies.
Time Frame
Baseline and 6 months
Title
Patient's experience using the new technology
Description
Self reported survey; and for a subset of participants, an interview or focus group
Time Frame
Survey: 6 Months; Interview/focus group: between 6-12 months
Title
Care Managers experience using the new technology
Description
Interview or focus group of care managers
Time Frame
Up to 5 years
Title
Care manager (CM) satisfaction with Collaborative Care Management (CoCM) of depression
Description
Measures CM satisfaction with implementation of CoCM.
Time Frame
At the end of the study or when a Care Manager leaves their role (Up to 5 years)
Title
Oncology provider's perception of patient's adherence to cancer treatment
Description
The patient's primary oncology provider will complete a standardized questionnaire to report delays or disruptions encountered in their planned 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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesse R. Fann
Phone
206-685-4280
Email
fann@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesse R. Fann
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
MultiCare Regional Cancer Center - Gig Harbor
City
Gig Harbor
State/Province
Washington
ZIP/Postal Code
98335
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blair Irwin
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesse R. Fann
Phone
206-685-4280
Email
fann@uw.edu
First Name & Middle Initial & Last Name & Degree
Jesse R. Fann
Facility Name
MultiCare Regional Cancer Center - Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blair Irwin

12. IPD Sharing Statement

Plan to Share IPD
No

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

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