Durham, North Carolina 27705


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.

Study summary:

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.



Primary Contact:

Principal Investigator
Laura Porter, Ph.D.
Duke University

Laura Porter, Ph.D.
Phone: 919-416-3436
Email: Laura.porter@duke.edu

Backup Contact:

Email: keefe003@mc.duke.edu
Francis Keefe, Ph.D.
Phone: 919-416-3401

Location Contact:

Durham, North Carolina 27705
United States

Laura Porter, Ph.D
Phone: 919-416-3436
Email: porte008@mc.duke.edu

Site Status: Recruiting

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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