Communication and Hospice Online With Optimal Support and Engagement
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Intermittent Hospice Team Support
Other interventionIntermittent hospice team support will be provided per standard of care guidelines.
Online Support Group with untrained facilitator
Other interventionThe 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.
Online Support Group with trained facilitator
Other interventionThe 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.
Treatment groups
567 Participants
are divided into 3 treatment groupsGroup A: Usual Care (UC)Active comparator 1 intervention
Group B: Usual Care Online Social Support (UCOSG)Active comparator 2 interventions
Group C: CHOOSE InterventionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and every 14 days until completion of study (estimated total time 3 months)2
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.
Time frame
Baseline and every 14 days until completion of study (estimated total time 3 months)Secondary outcomes
1
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Well Being Domain Score
The PROMIS Physical Well Being Domain measures mobility and ability to perform daily activities and is taken from the PROMIS Scale v1.2 Global Health. The domain contains four-items ranked on various Likert scales. One-items addressing general physical health is ranked on a 5-point Likert Scale from 5-Excellent to 1-Poor. One item addressing physical activities is ranked on a 5-point Likert scale from 5-Completely to 1-Not all. One item addressing fatigue is ranked on a 5-point Likert scale from 5-None to 1-Very Severe. One item addressing pain on average is ranked from a scale from 0-no pain to 10-worst pain imaginable. Scores range from 0-50 with higher the score indicates higher physical function.
Time frame
Baseline and every 14 days until completion of study (estimated total time 3 months)2
Changes in PROMIS Mental Well Being Score
The PROMIS Mental Well Being score is taken from four-times on the PROMIS Scale v1.2 Global Health. The 4 item sub-scale are administered using 5-point Likert Scale. Three items are ranked on a 5-point Likert Scale from 5-Excellent to 1-Poor. One item addressing emotional problems is ranked on a 5-point Likert scale from 5-Never to 1-Always. Scores range from 0-50 and generally the higher the score indicates greater mental well-being.
Time frame
Baseline and every 14 days until completion of study (estimated total time 3 months)3
Changes in University of California Los Angeles (UCLA) Loneliness Scale-3 score
The UCLA Loneliness Scale-3 is a 3-item scale that assesses loneliness. Each item is assessed by a 3-point Likert scale as follows: 1-Hardly ever, 2-Some of the time, and 3-Often. Scores range from 3-9, with the lower the scores indicating less loneliness.
Time frame
Baseline and every 14 days until completion of study (estimated total time 3 months)4
Changes in Zarit Burden-7 Interview score
The Zarit Burden-7 is a 7-item interview used to measure strain in family and informal caregivers. Each item is ranked using a 5-point Likert scale from 0 (Never) to 4 (Nearly Always). Total score ranges from 0-42. Generally, higher scores indicate a higher level of burden.
Time frame
Baseline and every 14 days until completion of study (estimated total time 3 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov
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