ACCESS (Access for Cancer Caregivers for Education and Support for Shared Decision Making) (ACCESS)
March 28, 2023 updated by: Debra Parker Oliver, Washington University School of Medicine
ACCESS (Access for Cancer Caregivers for Education and Support for Shared Decision)
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.
Study Overview
Status
Completed
Intervention / Treatment
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:
- 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.
Study Type
Interventional
Enrollment (Actual)
489
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 64503
- Hospice Compassus
-
Kansas City, Missouri, United States, 64055
- CrossRoads Hospice
-
Saint Louis, Missouri, United States, 63114
- Barnes Jewish Hospice
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Enhanced Usual Care
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
The family caregivers in this group only participates in the Facebook groups, not in the shared decision making
|
Participants will be enrolled in a Secret Facebook group for social support and education
|
|
Experimental: ACCESS
The family caregivers in this group participates in Facebook and web conferencing for shared decision making
|
Participants will be enrolled in a Secret Facebook group for social support and education
Intervention will have two components.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Generalized Anxiety Disorder- 7
Time Frame: Upon enrollment, 14 days, 28 days, 60 days and 90 days
|
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
Time Frame: Upon enrollment and 28 days
|
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
Time Frame: Upon enrollment and 28 days
|
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
Time Frame: Upon enrollment, 14 days, 28 days, 60 days and 90 days
|
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
Time Frame: Upon enrollment, 14 days, 28 days, and 90 days
|
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)
Time Frame: Upon enrollment, 14 days, 28 days, 60 days, and 90 days
|
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
Time Frame: Upon enrollment, 14 days, 28 days, 60 days, and 90 days
|
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
Time Frame: Upon enrollment and 28 days
|
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)
Time Frame: 14 days, 28 days, and 60 days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Debra Oliver, PhD, Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2017
Primary Completion (Actual)
November 22, 2021
Study Completion (Actual)
November 22, 2021
Study Registration Dates
First Submitted
October 6, 2016
First Submitted That Met QC Criteria
October 6, 2016
First Posted (Estimate)
October 10, 2016
Study Record Updates
Last Update Posted (Actual)
April 20, 2023
Last Update Submitted That Met QC Criteria
March 28, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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