Communication and Hospice Online With Optimal Support and Engagement (CHOOSE)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 567
- Locations
- 1
- Primary Endpoint
- Changes in Patient Health Questionnaire (PHQ-9) score
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Eligibility Criteria:
- •Family caregiver of cancer patient receiving hospice care from an affiliated hospice organization. Only 1 FCG per patient may be enrolled.
- •At least 18 years of age.
- •Can speak and understand English.
- •Able to access the internet.
- •Has a Facebook account or is willing to create a Facebook account in order to be in this study
Exclusion Criteria
- Not provided
Arms & Interventions
Usual Care (UC)
Patients randomized to the UC arm will receive the standard of care of intermittent hospice team support.
Intervention: Intermittent Hospice Team Support (Other)
Usual Care Online Social Support (UCOSG)
Patients 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.
Intervention: Intermittent Hospice Team Support (Other)
Usual Care Online Social Support (UCOSG)
Patients 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.
Intervention: Online Support Group with untrained facilitator (Other)
CHOOSE Intervention
Patients 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.
Intervention: Intermittent Hospice Team Support (Other)
CHOOSE Intervention
Patients 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.
Intervention: Online Support Group with trained facilitator (Other)
Outcomes
Primary Outcomes
Changes in Patient Health Questionnaire (PHQ-9) score
Time Frame: Baseline and every 14 days until completion of study (estimated total time 3 months)
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.
Changes in General Anxiety Disorder (GAD-7) score
Time Frame: Baseline and every 14 days until completion of study (estimated total time 3 months)
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.
Secondary Outcomes
- 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))
- Changes in Interpersonal Support Evaluation List (ISEL-SF) score(Baseline and every 14 days until completion of study (estimated total time 3 months))
- Changes in Online Social Support Scale (OSS) score(Baseline and every 14 days until completion of study (estimated total time 3 months))
- Changes in The Group Identification Scale (GIS)(Baseline and every 14 days until completion of study (estimated total time 3 months))
- Changes in the Social Disconnectedness Perceived Isolation (SDPI) Social Disconnectedness subscale score(Baseline and every 14 days until completion of study (estimated total time 3 months))
- Changes in Social Disconnectedness Perceived Isolation (SDPI) Perceived Isolation Subscale score(Baseline and every 14 days until completion of study (estimated total time 3 months))
- Changes in Facebook intensity scale score(Baseline and every 14 days until completion of study (estimated total time 3 months))
- Count of Direct and indirect thread sequences(Throughout timeline of trial (estimated time 3 months))
- Changes in Safety Questions score(Baseline and every 14 days until completion of study (estimated total time 3 months))