Caregiver-Guided Pain Management Training in Palliative Care



Status:Active, not recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/10/2019
Start Date:July 2015
End Date:November 2020

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The purpose of this study is to develop more effective ways to help patients and their
caregivers cope with cancer pain. The investigators are looking at the usefulness of a
Caregiver-Guided Pain Management Training Intervention versus Pain Education.

The primary aim of this study is to test the efficacy for the Caregiver-Guided Pain
Management Training intervention to improve the caregiver's self-efficacy for helping the
patient manage pain. Secondary aims include testing the effectiveness of the CG-PMT
intervention to improve patient pain severity, patient self-efficacy for pain management and
patient psychological distress, as well as short-term caregiver adjustment and caregiver
adjustment following the patient's death.

In this multi-site study, 236 dyads (patients with cancer pain and their family caregivers)
will be randomized to either a Caregiver-Guided Pain Management Training protocol or to an
Enhanced Treatment-as-Usual control condition. Dyads in the Caregiver-Guided Pain Management
condition will receive three one-hour sessions conducted via videoconference. Dyads in the
Enhanced Treatment-as-Usual condition will receive educational material about cancer pain and
its management but will not receive any study-related treatment sessions. Assessments will be
conducted with patients and caregivers before and after treatment, and with caregivers 3
months and 6 months following the patient's death. The primary hypothesis to be tested is
that caregivers who receive the intervention will report significantly higher levels of
self-efficacy for helping the patient manage pain than caregivers in the control condition.
Secondary aims will focus on (a) improvements in short-term caregiver adjustment as well as
caregiver adjustment following the patient's death, and (b) patient pain severity,
self-efficacy for pain management, and psychological distress.

Patient Inclusion Criteria:

1. clinical diagnosis Stage 4 solid or hematologic malignancy and nonresectable Stage 3
gastrointestinal (GI) cancer

2. life expectancy of < 1 month

3. worst pain in the past 2 weeks greater than or equal to 4 on the 0-10 pain scale,

4. have an identified caregiver who is also willing to participate,

5. at least 18 years old, 6) fluent in English.

Caregiver Inclusion Criteria:

1. at least 18 years old

2. fluent in English

Patient Exclusion Criteria:

1. Palliative Performance Scale rating <40,

2. current external radiation therapy for reduction of pain

3. unable to provide informed consent or complete study procedures as determined by
clinical or study staff.

Caregiver Exclusion Criteria:

1) unable to provide informed consent or complete study procedures as determined by
clinical or study staff.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Laura Porter, Ph.D
Phone: 919-416-3436
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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mi
from
Durham, NC
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