ACCESS (Access for Cancer Caregivers for Education and Support for Shared Decision Making)

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Evaluate the effect of access on family caregiver anxiety, pain knowledge and patient pain. Evaluate the effect of Facebook groups as educational emotional support for family caregivers Assess staff and family caregiver satisfaction with the shared decision making process.

Official Title
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ACCESS (Access for Cancer Caregivers for Education and Support for Shared Decision)

Conditions
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Cancer, Pain

Intervention / Treatment
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* Behavioral: Facebook
* Behavioral: ACCESS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is caregiving for a patient enrolled in the participating hospice Over 18 years of age Is caregiving for a patient with a diagnosis of cancer Willing to have a Facebook account and post at least 1x per week if in intervention group Exclusion Criteria: No one under the age of 18 Is caregiving for a patient enrolled in hospice agencies other than those participating in the study Unwilling to participate in social media Is caregiving for a patient with a diagnosis other than cancer Is caregiving for a patient with a life expectancy of less than 2 weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Enhanced Usual Care<br>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: Facebook<br>The family caregivers in this group only participates in the Facebook groups, not in the shared decision making | Behavioral: Facebook<br>* Participants will be enrolled in a Secret Facebook group for social support and education<br>|
| Experimental: ACCESS<br>The family caregivers in this group participates in Facebook and web conferencing for shared decision making | Behavioral: Facebook<br>* Participants will be enrolled in a Secret Facebook group for social support and education<br>Behavioral: ACCESS<br>* Intervention will have two components. Participants will be enrolled in a Secret Facebook group for social support and education Participants will use web conferencing technology to participate in their interdisciplinary team meeting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hospice, caregiver