Caregiver-Guided Pain Management Training in Palliative Care

Not Applicable

Completed

• Conditions: Advanced Cancer
• Interventions: Behavioral: Enhanced treatment-as-usual (TAU); Behavioral: Caregiver-guided pain management training (CG-PMT)

• Registration Number: NCT02430467
• Lead Sponsor: Duke University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2015-04-24
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-04-30
• Study Start: 2015-07
• Primary Completion: 2018-11-01
• Study Completion: 2019-10-04
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 452

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced treatment-as-usual (TAU)	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.
Caregiver-guided pain management training protocol (CG-PMT)	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

Primary Outcome Measures

Name	Time	Method
Change in caregiver self-efficacy for helping the patient manage pain	baseline, post-intervention (3 weeks)	Caregiver Self-Efficacy Scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States