Washington University School of Medicine
St Louis, Missouri, 63110, United States
NCT Number: NCT07764432
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 opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
St Louis, Missouri, 63110, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Eligibility Criteria:
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.
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.
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.
Time frame: Baseline and every 14 days until completion of study (estimated total time 3 months)
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)
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)
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)
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)
The CQLI-R contains four-items ranking physical, financial, emotional, and social quality of life. Each item is ranked from 0 to 10 by the caregiver with 0 representing lowest quality of life and 10 representing highest quality of life. Total scores range from 0 to 40 with lower scores indicating lower quality of life to higher scores indicating higher quality of life.
Time frame: Baseline and every 14 days until completion of study (estimated total time 3 months)
The ISEL-SF measures perceived social support. The domain contains 12-items with four subscales. Each item is ranked on a 4-point scale as follows: 3-definitely accurate, 2-probably true, 1-probably false, and 0-false). Total scores range from 0 to 48 with higher scores indicating higher levels of perceived social support.
Time frame: Baseline and every 14 days until completion of study (estimated total time 3 months)
The OSS is a 40-item measure assessing the perception of how well social support needs are met with the online group. Items are scores with a 5-point Likert scale as follows: 0 = never, 1 = rarely, 2 = sometimes, 3 = pretty often, 4 = alot. Total score range from 0-160. Higher scores indicate more social support.
Time frame: Baseline and every 14 days until completion of study (estimated total time 3 months)
The GIS is 4-item scale that measures the expression of shared identity within the online support group. Each question is ranked according to a 7-point Likert scale from 1= strongly disagree to 7 = strongly agree. Final score is the average of the four questions and ranges from 0-7. The higher the score indicates a higher sense of shared identity.
Time frame: Baseline and every 14 days until completion of study (estimated total time 3 months)
The SDPI is a 17-item scale that measures feelings of disconnectedness and isolation. The SDPI has two subscales: Social Disconnectedness Scale and Perceived Isolation Scale.
The Social Disconnectedness Scale contains 8-items and measures physical ties. Items include contact frequency and self-reported numbers. All items are scored by taking an average. Scores have generally ranged from -1.30 to 2.34 with lower scores indicated more connectedness and higher scores indicating more disconnectedness.
Time frame: Baseline and every 14 days until completion of study (estimated total time 3 months)
The SDPI is a 17-item scale that measures feelings of disconnectedness and isolation. The SDPI has two subscales: Social Disconnectedness Scale and Perceived Isolation Scale.
The Perceived Isolation Scale includes 9-items that measure loneliness and social support. Six-items assesses social support and are ranked on a 3- or 4-point Likert scale. Three-items are included from the UCLA Loneliness Scale assessed by a 3-point Likert scale as follows: 1-Hardly ever, 2-Some of the time, and 3-Often.
Higher overall final scores indicate greater intensity of perceived isolation.
Time frame: Baseline and every 14 days until completion of study (estimated total time 3 months)
The Facebook intensity scale is an 8-item scale that measures active Facebook use and emotional connection to Facebook and integration of Facebook into daily life. Two questions assess number of Facebook friends and time spent on Facebook. Six of the eight questions use a 5-point Likert scale ranked from 1-5 (1= strongly disagree to 5 = strongly agree). The higher the score indicates the participant's engagement and usage of Facebook is greater.
Time frame: Throughout timeline of trial (estimated time 3 months)
Threads refer to the communication posts within online support groups and thread sequences are scenarios to coordinate communication. Thread sequences are categorized as indirect or direct strategies. A direct strategy is categorized as an initial post to open discussion by the facilitator. Indirect strategy is categorized as a reply to a facilitator to invite further discussion. There are four direct and four indirect sequence scenarios for a total of eight scenarios to analyze family caregivers' response and interaction.
Thread sequences will be reported for indirect and direct thread sequences.
Time frame: Baseline and every 14 days until completion of study (estimated total time 3 months)
The Safety Question Questionnaire is a 2-question survey to assess the perception of safe communication in the online support group. The survey uses a 6-point Likert scale ranked from 0-5 (0=disagree and 5=strongly agree). Total score range from 0-10. Generally, the higher the score indicates a higher perception of safety.
Trial opening soon.
Get NotifiedWashington University School of Medicine
Other
Communication and Hospice Online With Optimal Support and Engagement (CHOOSE)
Acronym: CHOOSE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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