Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

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.


Study is Available At:


Original ID:

Pro00057512


NCT ID:

NCT02430467


Secondary ID:

1R01NR015348-01


Study Acronym:


Brief Title:

Caregiver-Guided Pain Management Training in Palliative Care


Official Title:

Caregiver-Guided Pain Management Training in Palliative Care


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Duke University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

452


Enrollment Type:

Actual


Overall Contact Information

Official Name:Laura Porter, Ph.D.
Principal Investigator
Duke University

Study Dates

Start Date:July 2015
Completion Date:November 2020
Completion Type:Anticipated
Primary Completion Date:November 2018
Primary Completion Type:Actual
Verification Date:September 2019
Last Changed Date:September 19, 2019
First Received Date:April 24, 2015

Study Outcomes

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

Study Interventions

Intervention Type:Behavioral
Name:Caregiver-guided pain management training (CG-PMT)
Description: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 techniqu
Arm Name:Caregiver-guided pain management training protocol
Intervention Type:Behavioral
Name:Enhanced treatment-as-usual (TAU)
Description: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 beh
Arm Name:Enhanced treatment-as-usual (TAU)

Study Arms

Study Arm Type:Active Comparator
Arm Name:Enhanced treatment-as-usual (TAU)
Description: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 beh
Study Arm Type:Active Comparator
Arm Name:Caregiver-guided pain management training protocol (CG-PMT)
Description: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 techniqu

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Duke University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Nursing Research (NINR)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.