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Caregiver-Guided Pain Management Training in Palliative Care

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ClinicalTrials.gov Identifier: NCT02430467
Recruitment Status : Recruiting
First Posted : April 30, 2015
Last Update Posted : October 10, 2018
Sponsor:
Collaborators:
National Institute of Nursing Research (NINR)
Palliative Care Research Cooperative Group
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Behavioral: Caregiver-guided pain management training (CG-PMT) Behavioral: Enhanced treatment-as-usual (TAU) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 472 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 : July 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in caregiver self-efficacy for helping the patient manage pain [ Time Frame: baseline, post-intervention (3 weeks) ]
    Caregiver Self-Efficacy Scale


Secondary Outcome Measures :
  1. Change in caregiver strain [ Time Frame: baseline, following intervention (3 weeks) ]
    Caregiver Strain Index

  2. Change in caregiver satisfaction [ Time Frame: baseline, following intervention (3 weeks) ]
    Caregiving Satisfaction Scale

  3. Change in caregiver psychological distress [ Time Frame: baseline, following intervention (3 weeks) ]
    Center for Epidemiology Studies Short Depression Scale

  4. Change in caregiver psychological distress [ Time Frame: following death of patient (4 mos & 11 mos) ]
    Trait Anxiety Scale

  5. Change in caregiver health behaviors [ Time Frame: following death of patient (4 mos & 11 mos) ]
    Self-Administered Comorbidity Questionnaire

  6. Change in caregiver global health rating [ Time Frame: following death of patient (4 mos & 11 mos) ]
    Global health rating

  7. Change in patient pain [ Time Frame: baseline, post-intervention (3 weeks) ]
    Brief Pain Inventory

  8. Change in patient self-efficacy [ Time Frame: baseline, post-intervention (3 weeks) ]
    Patient Self-Efficacy Scale

  9. Change in patient psychological distress [ Time Frame: baseline, post-intervention (3 weeks) ]
    Hospital Anxiety and Depression Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02430467


Contacts
Contact: Laura Porter, Ph.D. 919-416-3436 Laura.porter@duke.edu
Contact: Francis Keefe, Ph.D. 919-416-3401 keefe003@mc.duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Laura Porter, Ph.D    919-416-3436    porte008@mc.duke.edu   
Contact: Rita Butterfield, Ph.D    919-416-3434    rita.butterfield@duke.edu   
Principal Investigator: Laura Porter, Ph.D         
Principal Investigator: Francis Keefe, Ph.D         
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

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02430467     History of Changes
Other Study ID Numbers: Pro00057512
1R01NR015348-01 ( U.S. NIH Grant/Contract )
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018