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

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ClinicalTrials.gov Identifier: NCT02929108
Recruitment Status : Recruiting
First Posted : October 10, 2016
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Debra Parker Oliver, PhD, MSW, University of Missouri-Columbia

Brief Summary:
The project will test the effect of educating and supporting caregivers of hospice cancer patients on their active participation in shared decision making in the plan of care for their patients.

Condition or disease Intervention/treatment Phase
Cancer Pain Behavioral: Facebook Behavioral: ACCESS Not Applicable

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 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 caregivers
  3. Assess staff and caregiver satisfaction with the shared decision making process.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: ACCESS (Access for Cancer Caregivers for Education and Support for Shared Decision
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Enhanced Usual Care
This group will receive usual hospice care which has been enhanced as the staff have been trained in shared decision making.
Experimental: Facebook
This group only participates in the Facebook groups, not in the shared decision making
Behavioral: Facebook
Participants will be enrolled in a Secret Facebook group for social support and education

Experimental: ACCESS
This group participates in facebook and web conferencing for shared decision making
Behavioral: Facebook
Participants will be enrolled in a Secret Facebook group for social support and education

Behavioral: ACCESS

Intervention will have two components.

  1. Participants will be enrolled in a Secret Facebook group for social support and education
  2. Participants will use web conferencing technology to participate in their interdisciplinary team meeting




Primary Outcome Measures :
  1. Change in Generalized Anxiety Disorder- 7 [ Time Frame: Upon enrollment, 14 days, 28 days, 60 days and 90 days ]
    A screening tool to quantify participants anxiety. Scale is 0-7


Secondary Outcome Measures :
  1. Change in Brief Pain Inventory [ Time Frame: Upon enrollment, 14 days, 28 days, 60 days and 90 days ]
    Four single item measures of pain intensity for the proceeding 24 hours.

  2. Change in Family Pain Questionnaire [ Time Frame: Upon enrollment, 14 days, 28 days, 60 days and 90 days ]
    A scale which measures pain knowledge and the family caregiving experience

  3. 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 0-10



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrolled in the participating hospice
  • Over 18 years of age
  • Has 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
  • Enrolled in hospice agencies other than those participating in the study
  • Unwilling to participate in social media
  • A patient with a diagnosis other than cancer
  • A patient with a life expectancy of less than 2 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929108


Contacts
Contact: Debra Oliver, PhD 573-884-5301 oliverdr@missouri.edu
Contact: Karla Washington, PhD 573-884 2119 washingtonkar@health.missouri.edu

Locations
United States, Missouri
Hospice Compassus Recruiting
Columbia, Missouri, United States, 64503
Contact: Christie Merrick, MS       merrickc@missouri.edu   
CrossRoads Hospice Recruiting
Kansas City, Missouri, United States, 64055
Contact: Megan Mooney, MSW       mooneym@missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Debra Oliver, PhD University of Missouri-Columbia

Responsible Party: Debra Parker Oliver, PhD, MSW, Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02929108     History of Changes
Other Study ID Numbers: 2006270
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Debra Parker Oliver, PhD, MSW, University of Missouri-Columbia:
hospice
caregiver