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

Pain Clinical Trial

— ACCESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929108
• Other study ID #: 2006270
• Secondary ID: 5R01CA203999
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: November 22, 2021

Study information

• Verified date: March 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 489
• Est. completion date: November 22, 2021
• Est. primary completion date: November 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Pain

Intervention

Behavioral:
• Facebook
Participants will be enrolled in a Secret Facebook group for social support and education
• ACCESS
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

Locations

Country	Name	City	State
United States	Hospice Compassus	Columbia	Missouri
United States	CrossRoads Hospice	Kansas City	Missouri
United States	Barnes Jewish Hospice	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine