Durham, North Carolina 27705


Purpose:

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.


Criteria:

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.


NCT ID:

NCT02430467


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: November 19, 2017

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