Caregiver-Guided Pain Management Training in Palliative Care

Advanced Cancer Clinical Trial

Official title:

Caregiver-Guided Pain Management Training in Palliative Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02430467
• Other study ID #: Pro00057512
• Secondary ID: 1R01NR015348-01
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: October 4, 2019

Study information

• Verified date: August 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: October 4, 2019
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institute of Nursing Research (NINR), Palliative Care Research Cooperative Group

Country where clinical trial is conducted

United States, 

Outcome

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