Communication and Hospice Online With Optimal Support and Engagement
CHOOSE
2 other identifiers
interventional
567
1 country
1
Brief Summary
The project is a multisite, three-group randomized control trial (RCT) with equal and parallel mixed-methods analysis that allows standardized measures combined with rich qualitative data to test hypotheses and answer research questions. Family caregivers (FCGs) of hospice cancer patients will be recruited and randomized into one of three groups: usual hospice care only (UC), usual care online support group (UCOSG) (without communication strategies), and the CHOOSE intervention group (with communication focus).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2027
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2026
CompletedFirst Posted
Study publicly available on registry
August 14, 2026
CompletedStudy Start
First participant enrolled
February 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2031
Study Completion
Last participant's last visit for all outcomes
April 30, 2031
August 14, 2026
August 1, 2026
4.2 years
August 6, 2026
August 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes in Patient Health Questionnaire (PHQ-9) score
The PHQ-9 is a 9-item questionnaire that assesses patient depression. The 9-items are ranked by Likert Scale from 0 - Not at all, 1 - Several days, 2 - More than half the days, and 3 - nearly every day. Scores range from 0-27 with lower scores indicating no or minimal depression and higher scores indicating moderate to severe depression.
Baseline and every 14 days until completion of study (estimated total time 3 months)
Changes in General Anxiety Disorder (GAD-7) score
The GAD-7 includes 7-items ranked by Likert scale to measure anxiety severity over the past two weeks. Each item is ranked by 4-point Likert scale as follows: 0-Not at all, 1-Several days, 2-More than half the days, and 3-Nearly every day. Scores range from 0-21, with a higher score indicating higher anxiety.
Baseline and every 14 days until completion of study (estimated total time 3 months)
Secondary Outcomes (13)
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Well Being Domain Score
Baseline and every 14 days until completion of study (estimated total time 3 months)
Changes in PROMIS Mental Well Being Score
Baseline and every 14 days until completion of study (estimated total time 3 months)
Changes in University of California Los Angeles (UCLA) Loneliness Scale-3 score
Baseline and every 14 days until completion of study (estimated total time 3 months)
Changes in Zarit Burden-7 Interview score
Baseline and every 14 days until completion of study (estimated total time 3 months)
Changes in Caregiver Quality of Life Index-Revised (CQLI-R) score
Baseline and every 14 days until completion of study (estimated total time 3 months)
- +8 more secondary outcomes
Study Arms (3)
Usual Care (UC)
ACTIVE COMPARATORPatients randomized to the UC arm will receive the standard of care of intermittent hospice team support.
Usual Care Online Social Support (UCOSG)
ACTIVE COMPARATORPatients randomized to the UCOSG arm will have access to an online support group in addition to the standard of care of intermittent hospice team support. The online support group is led by an untrained facilitator.
CHOOSE Intervention
EXPERIMENTALPatients randomized to the CHOOSE intervention will have access to standard of care of intermittent hospice team support and access to an online support group led by a trained facilitator.
Interventions
Intermittent hospice team support will be provided per standard of care guidelines.
The online support group will be held via private, hidden Facebook. The online support group will be led by an untrained facilitator whose role is to enroll participants and maintain guidelines. Specifically, the untrained facilitator has the following roles: enrolls individuals in the group, monitors the discussion to maintain the guidelines to protect the group's integrity, provides information on resources for technical assistance, and notes any outside online groups to which they belong.
The online support group will be held via private, hidden Facebook. The online support group led by a trained facilitator focuses on building safe communication and encouraging participant engagement. The trained facilitator has the following roles: enrolls individuals in the group, monitors the discussion to enforce the guidelines and protect the group's integrity, provides technical assistance, moderates group discussions, initiates threads using direct and indirect strategies and communication topic openings, builds a safe environment for communication, encourages participation, and organizes and coordinates Facebook Live activities.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Debra P Oliver, PhD, MSW
Washington University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2026
First Posted
August 14, 2026
Study Start (Estimated)
February 1, 2027
Primary Completion (Estimated)
April 30, 2031
Study Completion (Estimated)
April 30, 2031
Last Updated
August 14, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available no later than at the time of publication or by the end of the award period, whichever occurs earlier. The duration of data preservation and sharing will be governed by the retention policies of Digital Commons Data@Becker. Currently, the retention policy of Digital Commons Data@Becker ensures perpetual availability of all data shared in the repository, with contingency plans in place for potential changes in repository hosting.
- Access Criteria
- De-identified data will be available via controlled access only through Data Use Agreement (DUA).
De-identified data and metadata from the project will be archived through the Washington University School of Medicine institutional data repository, Digital Commons Data@Becker. Survey data will be stored in CSV format and transcripts of audio-record interviews will be stored in TXT format.