Clinical trial NCT02929108: ACCESS (Access for Cancer Caregivers for Education and Support for Shared Decision Making)
Official title: ACCESS (Access for Cancer Caregivers for Education and Support for Shared Decision)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Pain
Keywords: hospice
caregiver
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-10-10
Enrollment: 489
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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:

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in Generalized Anxiety Disorder- 7
timeFrame: Upon enrollment, 14 days, 28 days, 60 days and 90 days
Secondary outcomes:
measure: Change in Family Pain Questionnaire - Experience
timeFrame: Upon enrollment and 28 days
measure: Change in Family Pain Questionnaire - Knowledge
timeFrame: Upon enrollment and 28 days
measure: Change in Caregiver Quality of Life
timeFrame: Upon enrollment, 14 days, 28 days, 60 days and 90 days
measure: Perceived Involvement of Care Scale
timeFrame: Upon enrollment, 14 days, 28 days, and 90 days
measure: Public Health Questionnaire (PHQ 9)
timeFrame: Upon enrollment, 14 days, 28 days, 60 days, and 90 days
measure: Edmonton Symptom Assessment
timeFrame: Upon enrollment, 14 days, 28 days, 60 days, and 90 days
measure: Zarit Burden Scale
timeFrame: Upon enrollment and 28 days
measure: Caregiver Communication Questionnaire (CCCQ)
timeFrame: 14 days, 28 days, and 60 days
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Hospice Compassus
state: Missouri
city: Kansas City
country: United States
facility: CrossRoads Hospice
state: Missouri
city: Saint Louis
country: United States
facility: Barnes Jewish Hospice
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Debra Oliver, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.