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

Not Applicable

Completed

• Conditions: Cancer; Pain
• Interventions: Behavioral: Facebook; Behavioral: ACCESS

• Registration Number: NCT02929108
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study First Submitted: 2016-10-06
• Study First Submitted QC: 2016-10-06
• Study First Posted: 2016-10-10
• Study Start: 2017-04-01
• Primary Completion: 2021-11-22
• Study Completion: 2021-11-22
• Results First Submitted: 2022-11-15
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-28
• Last Update Submitted: 2023-03-28
• Results First Posted: 2023-04-20
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 489

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Facebook	Facebook	The family caregivers in this group only participates in the Facebook groups, not in the shared decision making
ACCESS	ACCESS	The family caregivers in this group participates in Facebook and web conferencing for shared decision making
ACCESS	Facebook	The family caregivers in this group participates in Facebook and web conferencing for shared decision making

Primary Outcome Measures

Name	Time	Method
Change in Generalized Anxiety Disorder- 7	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.

Secondary Outcome Measures

Name	Time	Method
Perceived Involvement of Care Scale	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.
Change in Family Pain Questionnaire - Experience	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.
Change in Family Pain Questionnaire - Knowledge	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.
Zarit Burden Scale	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.
Caregiver Communication Questionnaire (CCCQ)	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.
Change in Caregiver Quality of Life	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.
Edmonton Symptom Assessment	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.
Public Health Questionnaire (PHQ 9)	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.

Trial Locations

Locations (3)

Hospice Compassus; 🇺🇸 Columbia, Missouri, United States

Barnes Jewish Hospice; 🇺🇸 Saint Louis, Missouri, United States

CrossRoads Hospice; 🇺🇸 Kansas City, Missouri, United States