Caregiver-Guided Pain Management Training in Palliative Care

August 23, 2023 updated by: Duke University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

452

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Caregiver-guided pain management training protocol (CG-PMT)
Patient-caregiver dyads in the CG-PM arm of the study will receive 3 50-minute sessions via Skype with a masters-level therapist over a 3-week period. The intervention integrates educational information about cancer pain and its management with a behavioral training program to teach patients and caregivers pain coping skills including relaxation, imagery, and activity pacing, and to teach caregivers how to guide and coach the patient in the practice and application of these pain control techniques
Behavioral: Caregiver-guided pain management training (CG-PMT)
Patient-caregiver dyads in the CG-PM arm of the study will receive 3 50-minute sessions via Skype with a masters-level therapist over a 3-week period. The intervention integrates educational information about cancer pain and its management with a behavioral training program to teach patients and caregivers pain coping skills including relaxation, imagery, and activity pacing, and to teach caregivers how to guide and coach the patient in the practice and application of these pain control techniques.
Active Comparator: Enhanced treatment-as-usual (TAU)
Patient-caregiver dyads in the Enhanced TAU condition will receive the same educational video and booklet on cancer pain and its management that is used as part of the CG-PMT intervention. They will also receive iPads with icons linked to reputable websites that provide educational information on cancer including cancer pain (e.g., ACS, NCI) and will be encouraged to utilize them for information and support. However, they will not meet with a study interventionist nor receive any training in behavioral pain coping skills.
Behavioral: Enhanced treatment-as-usual (TAU)
Patient-caregiver dyads in the Enhanced TAU condition will receive the same educational video and booklet on cancer pain and its management that is used as part of the CG-PMT intervention. They will also receive iPads with icons linked to reputable websites that provide educational information on cancer including cancer pain (e.g., ACS, NCI) and will be encouraged to utilize them for information and support. However, they will not meet with a study interventionist nor receive any training in behavioral pain coping skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in caregiver self-efficacy for helping the patient manage pain
Time Frame: baseline, post-intervention (3 weeks)
Caregiver Self-Efficacy Scale
baseline, post-intervention (3 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in caregiver strain
Time Frame: baseline, following intervention (3 weeks)
Caregiver Strain Index
baseline, following intervention (3 weeks)
Change in caregiver satisfaction
Time Frame: baseline, following intervention (3 weeks)
Caregiving Satisfaction Scale
baseline, following intervention (3 weeks)
Change in caregiver psychological distress
Time Frame: baseline, following intervention (3 weeks)
Center for Epidemiology Studies Short Depression Scale
baseline, following intervention (3 weeks)
Change in caregiver psychological distress
Time Frame: following death of patient (3 mos & 6 mos)
Trait Anxiety Scale
following death of patient (3 mos & 6 mos)
Change in caregiver health behaviors
Time Frame: following death of patient (3 mos & 6 mos)
Self-Administered Comorbidity Questionnaire
following death of patient (3 mos & 6 mos)
Change in caregiver global health rating
Time Frame: following death of patient (3 mos & 6 mos)
Global health rating
following death of patient (3 mos & 6 mos)
Change in patient pain
Time Frame: baseline, post-intervention (3 weeks)
Brief Pain Inventory
baseline, post-intervention (3 weeks)
Change in patient self-efficacy
Time Frame: baseline, post-intervention (3 weeks)
Patient Self-Efficacy Scale
baseline, post-intervention (3 weeks)
Change in patient psychological distress
Time Frame: baseline, post-intervention (3 weeks)
Hospital Anxiety and Depression Scale
baseline, post-intervention (3 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute of Nursing Research (NINR)
Palliative Care Research Cooperative Group

Investigators

  • Principal Investigator: Laura Porter, Ph.D., Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

October 4, 2019

Study Registration Dates

First Submitted

April 24, 2015

First Submitted That Met QC Criteria

April 29, 2015

First Posted (Estimated)

April 30, 2015

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00057512
  • 1R01NR015348-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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