Caregiver-Guided Pain Management Training in Palliative Care

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT02430467
Collaborator
National Institute of Nursing Research (NINR) (NIH), Palliative Care Research Cooperative Group (Other)
452
Enrollment
1
Location
2
Arms
51.1
Duration (Months)
8.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Caregiver-guided pain management training (CG-PMT)
  • Behavioral: Enhanced treatment-as-usual (TAU)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
452 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Caregiver-Guided Pain Management Training in Palliative Care
Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Nov 1, 2018
Actual Study Completion Date :
Oct 4, 2019

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Change in caregiver self-efficacy for helping the patient manage pain [baseline, post-intervention (3 weeks)]

    Caregiver Self-Efficacy Scale

Secondary Outcome Measures

  1. Change in caregiver strain [baseline, following intervention (3 weeks)]

    Caregiver Strain Index

  2. Change in caregiver satisfaction [baseline, following intervention (3 weeks)]

    Caregiving Satisfaction Scale

  3. Change in caregiver psychological distress [baseline, following intervention (3 weeks)]

    Center for Epidemiology Studies Short Depression Scale

  4. Change in caregiver psychological distress [following death of patient (3 mos & 6 mos)]

    Trait Anxiety Scale

  5. Change in caregiver health behaviors [following death of patient (3 mos & 6 mos)]

    Self-Administered Comorbidity Questionnaire

  6. Change in caregiver global health rating [following death of patient (3 mos & 6 mos)]

    Global health rating

  7. Change in patient pain [baseline, post-intervention (3 weeks)]

    Brief Pain Inventory

  8. Change in patient self-efficacy [baseline, post-intervention (3 weeks)]

    Patient Self-Efficacy Scale

  9. Change in patient psychological distress [baseline, post-intervention (3 weeks)]

    Hospital Anxiety and Depression Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Duke University Medical CenterDurhamNorth CarolinaUnited States27705

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT02430467
Other Study ID Numbers:
  • Pro00057512
  • 1R01NR015348-01
First Posted:
Apr 30, 2015
Last Update Posted:
Sep 23, 2021
Last Verified:
Sep 1, 2021

Study Results

No Results Posted as of Sep 23, 2021