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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA203999 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The project will test the effect of educating and supporting family caregivers of hospice cancer patients on their active participation in shared decision making in the plan of care for their patients.
This intervention will target education and emotional support to family caregivers of hospice cancer patients for a shared decision making process in the hospice care plan meetings The intervention ACCESS will consist of three components:
1: a Facebook group to provide the education and support; 2. web conferencing for family members into the hospice interdisciplinary care plan meeting 3, a structured shared decision making process to guide the team discussion.
Participants (family caregivers) will be randomly assigned to one of three groups, usual care, Facebook only, and Access.
The specific aims are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Usual Care | No Intervention | The family caregivers in his group will receive usual hospice care which has been enhanced as the staff have been trained in shared decision making. | |
| Experimental | The family caregivers in this group only participates in the Facebook groups, not in the shared decision making |
| |
| ACCESS | Experimental | The family caregivers in this group participates in Facebook and web conferencing for shared decision making |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral | Participants will be enrolled in a Secret Facebook group for social support and education |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Generalized Anxiety Disorder- 7 | A screening tool to quantify participant's anxiety. The scale ranges from 0-21. A higher score indicates a higher level of anxiety. | Upon enrollment, 14 days, 28 days, 60 days and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Family Pain Questionnaire - Experience | A scale which measures caregiver's experience dealing with patient pain. Scale ranges from 0-70. A higher score indicates higher pain experience. | Upon enrollment and 28 days |
| Change in Family Pain Questionnaire - Knowledge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra Oliver, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospice Compassus | Columbia | Missouri | 64503 | United States | ||
| CrossRoads Hospice |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35324322 | Derived | Parker Oliver D, Demiris G, Washington KT, Pitzer K, Ulrich C. The Effect of Digital Literacy on Participation in Social Media Clinical Trials in Cancer: Tailoring an Informed Consent Process. Telemed J E Health. 2022 Mar 21;28(11):1682-9. doi: 10.1089/tmj.2021.0555. Online ahead of print. | |
| 34825279 | Derived | Oliver DP, Washington KT, Pitzer K, Popejoy L, White P, Wallace AS, Grimsley A, Demiris G. Mixed methods analysis of hospice staff perceptions and shared decision making practices in hospice. Support Care Cancer. 2022 Mar;30(3):2679-2691. doi: 10.1007/s00520-021-06631-w. Epub 2021 Nov 25. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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Hospice patients were not enrolled to this study. Only family caregivers were enrolled to this study. Each family caregiver was only assigned to one group (intervention) and stayed in that group for the duration of their time in the study (up to 90 days). They were given surveys at 14, 28, 60, and 90 days. The number of family caregivers who received each intervention at each site is listed below.
This is a crossover cluster-randomized study where 7 hospice sites were assigned to an intervention sequence consisting of 2 of the 3 interventions: Facebook, Enhanced UsualCare, or ACCESS. There was at least one washout period of up to 90 days between interventions. The intervention for the hospice sites also started at different times.
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| ID | Title | Description |
|---|---|---|
| FG000 | Site 1: Facebook First, Then Access, Then Facebook | This site was assigned to the intervention sequence: Facebook First, Then Access, Then Facebook, and started in August 2017. Each intervention was approximately 12 months in length, with up to a 3-month washout period between interventions. Caregivers only received one intervention for up to 90 days. |
| FG001 | Site 2: Access First Then Enhanced Usual Care, Then Access | This site was assigned to the intervention sequence: Access First, Then Enhanced Usual Care, Then Access, and started in November 2017. Each intervention was approximately 12 months in length, with up to a 3-month washout period only between the first and second intervention. Caregivers only received one intervention for up to 90 days. |
| FG002 | Site 3: Access First, Then Enhanced Usual Care, Then Access | This site was assigned to the intervention sequence: Access First, Then Enhanced Usual Care, Then Access, and started in December 2017. Each intervention was approximately 12 months in length, with up to a 3-month washout period only between the first and second intervention. Caregivers only received one intervention for up to 90 days. |
| FG003 | Site 4: Enhanced Usual Care First, Then Facebook, Then Enhanced Usual Care | This site was assigned to the intervention sequence: Enhanced Usual Care First, Then Facebook, Then Enhanced Usual Care, and started in December 2017. Each intervention was approximately 12 months in length, with up to a 3-month washout period only between the second and third intervention. Caregivers only received one intervention for up to 90 days. |
| FG004 | Site 5: Facebook First, Then Enhanced Usual Care, Then Facebook | This site was assigned to the intervention sequence: Access First, Then Enhanced Usual Care, Then Access, and started in January 2018. Each intervention was approximately 12 months in length, with up to a 3-month washout period only between the first and second intervention. Caregivers only received one intervention for up to 90 days. |
| FG005 | Site 6: Enhanced Usual Care First, Then Facebook, Then Enhanced Usual Care | This site was assigned to the intervention sequence: Enhanced Usual Care First, Then Facebook, Then Enhanced Usual Care, and started in February 2018. Each intervention was approximately 12 months in length, with up to a 3-month washout period only between the second and third intervention. Caregivers only received one intervention for up to 90 days. |
| FG006 | Site 7: Access First ,Then Facebook | This site was assigned to the intervention sequence: Access First, Then Facebook, and started in September 2019. Each intervention was approximately 12 months in length, with up to a 3-month washout period between both interventions. Caregivers only received one intervention for up to 90 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Usual Care | The family caregivers in this group will receive usual hospice care which has been enhanced as the staff have been trained in shared decision making. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age is missing for some participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Generalized Anxiety Disorder- 7 | A screening tool to quantify participant's anxiety. The scale ranges from 0-21. A higher score indicates a higher level of anxiety. | Some questionnaires were not completed by the participant. | Posted | Mean | Standard Deviation | score on a scale | Upon enrollment, 14 days, 28 days, 60 days and 90 days |
|
Adverse events and all-cause mortality was followed from baseline through completion of follow-up (up to 90 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enhanced Usual Care | The family caregivers in this group will receive usual hospice care which has been enhanced as the staff have been trained in shared decision making. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Debra Oliver, Ph.D. | Washington University School of Medicine | 314-747-5361 | oliverd@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2020 | Nov 10, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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A pragmatic cluster randomized controlled trial will randomly assign hospice sites (cluster) to 2 of 3 groups: 1) Enhanced usual care 2) Enhanced usual care and private Facebook group 3) Enhanced usual care, private Facebook group, and ACCESS. Each hospice site (cluster) will go through 2 arms of the intervention but the family caregiver participants will only complete one arm.
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| ACCESS | Behavioral | Intervention will have two components.
|
|
A scale which measures pain knowledge. The scale ranges from 0-90. A higher score indicates a higher knowledge of pain. |
| Upon enrollment and 28 days |
| Change in Caregiver Quality of Life | Four question scale that measures caregivers quality of life. Scale ranges from 0-40. Higher score indicates higher quality of life. | Upon enrollment, 14 days, 28 days, 60 days and 90 days |
| Perceived Involvement of Care Scale | A scale measuring perceived involvement of care. Scale ranges from 13-65. Higher score indicates higher perceived involvement in care. | Upon enrollment, 14 days, 28 days, and 90 days |
| Public Health Questionnaire (PHQ 9) | A measure of depression. Scale ranges from 0-27. A higher score indicates higher depression. | Upon enrollment, 14 days, 28 days, 60 days, and 90 days |
| Edmonton Symptom Assessment | A scale that measures various patient symptoms as reported by caregiver such as pain, fatigue, depression, anxiety, appetite, and nausea. Scale ranges from 0-90. A higher score indicates higher degree of symptoms. | Upon enrollment, 14 days, 28 days, 60 days, and 90 days |
| Zarit Burden Scale | A scale that measures the level of burden on caregiver. Scale ranges from 0-28. A higher score indicates greater burden. | Upon enrollment and 28 days |
| Caregiver Communication Questionnaire (CCCQ) | A scale that measures the level of perception of caregiver centered communication by hospice staff. Scale ranges from 30-150. A higher score indicates greater perception of caregiver centered communication. | 14 days, 28 days, and 60 days |
| Kansas City |
| Missouri |
| 64055 |
| United States |
| Barnes Jewish Hospice | St Louis | Missouri | 63114 | United States |
| 34793244 | Derived | Starr LT, Bullock K, Washington K, Aryal S, Parker Oliver D, Demiris G. Anxiety, Depression, Quality of Life, Caregiver Burden, and Perceptions of Caregiver-Centered Communication among Black and White Hospice Family Caregivers. J Palliat Med. 2022 Apr;25(4):596-605. doi: 10.1089/jpm.2021.0302. Epub 2021 Nov 18. |
The family caregivers in this group only participates in the Facebook groups, not in the shared decision making
| BG002 | ACCESS | The family caregivers in this group participates in Facebook and web conferencing for shared decision making |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Sex is missing for one participant. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG002 | ACCESS | The family caregivers in this group participates in Facebook and web conferencing for shared decision making |
|
|
| Secondary | Change in Family Pain Questionnaire - Experience | A scale which measures caregiver's experience dealing with patient pain. Scale ranges from 0-70. A higher score indicates higher pain experience. | Some questionnaires were not completed by the participant. | Posted | Mean | Standard Deviation | score on a scale | Upon enrollment and 28 days |
|
|
|
| Secondary | Change in Family Pain Questionnaire - Knowledge | A scale which measures pain knowledge. The scale ranges from 0-90. A higher score indicates a higher knowledge of pain. | Some questionnaires were not completed by the participant. | Posted | Mean | Standard Deviation | score on a scale | Upon enrollment and 28 days |
|
|
|
| Secondary | Change in Caregiver Quality of Life | Four question scale that measures caregivers quality of life. Scale ranges from 0-40. Higher score indicates higher quality of life. | Some questionnaires were not completed by the participant. | Posted | Mean | Standard Deviation | score on a scale | Upon enrollment, 14 days, 28 days, 60 days and 90 days |
|
|
|
| Secondary | Perceived Involvement of Care Scale | A scale measuring perceived involvement of care. Scale ranges from 13-65. Higher score indicates higher perceived involvement in care. | Some questionnaires were not completed by the participant. | Posted | Mean | Standard Deviation | score on a scale | Upon enrollment, 14 days, 28 days, and 90 days |
|
|
|
| Secondary | Public Health Questionnaire (PHQ 9) | A measure of depression. Scale ranges from 0-27. A higher score indicates higher depression. | Some questionnaires were not completed by the participant. | Posted | Mean | Standard Deviation | score on a scale | Upon enrollment, 14 days, 28 days, 60 days, and 90 days |
|
|
|
| Secondary | Edmonton Symptom Assessment | A scale that measures various patient symptoms as reported by caregiver such as pain, fatigue, depression, anxiety, appetite, and nausea. Scale ranges from 0-90. A higher score indicates higher degree of symptoms. | Some questionnaires were not completed by the participant. | Posted | Mean | Standard Deviation | score on a scale | Upon enrollment, 14 days, 28 days, 60 days, and 90 days |
|
|
|
| Secondary | Zarit Burden Scale | A scale that measures the level of burden on caregiver. Scale ranges from 0-28. A higher score indicates greater burden. | Some questionnaires were not completed by the participant. | Posted | Mean | Standard Deviation | score on a scale | Upon enrollment and 28 days |
|
|
|
| Secondary | Caregiver Communication Questionnaire (CCCQ) | A scale that measures the level of perception of caregiver centered communication by hospice staff. Scale ranges from 30-150. A higher score indicates greater perception of caregiver centered communication. | Some questionnaires were not completed by the participant. | Posted | Mean | Standard Deviation | score on a scale | 14 days, 28 days, and 60 days |
|
|
|
| 0 |
| 126 |
| 0 |
| 126 |
| 0 |
| 126 |
| EG001 | The family caregivers in this group only participates in the Facebook groups, not in the shared decision making | 0 | 214 | 0 | 214 | 0 | 214 |
| EG002 | ACCESS | The family caregivers in this group participates in Facebook and web conferencing for shared decision making | 0 | 149 | 0 | 149 | 0 | 149 |
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| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 28 days |
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| 28 days |
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| 14 days |
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| 28 days |
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| 60 days |
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| 90 days |
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| 14 days |
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| 28 days |
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| 90 days |
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| 14 days |
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| 28 days |
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| 60 days |
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| 90 days |
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| 14 days |
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| 28 days |
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| 60 days |
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| 90 days |
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| 28 days |
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| 28 days |
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| 60 days |
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