NCT02430467

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
452

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2019

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

3.3 years

First QC Date

April 24, 2015

Last Update Submit

August 23, 2023

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in caregiver self-efficacy for helping the patient manage pain

    Caregiver Self-Efficacy Scale

    baseline, post-intervention (3 weeks)

Secondary Outcomes (9)

  • Change in caregiver strain

    baseline, following intervention (3 weeks)

  • Change in caregiver satisfaction

    baseline, following intervention (3 weeks)

  • Change in caregiver psychological distress

    baseline, following intervention (3 weeks)

  • Change in caregiver psychological distress

    following death of patient (3 mos & 6 mos)

  • Change in caregiver health behaviors

    following death of patient (3 mos & 6 mos)

  • +4 more secondary outcomes

Study Arms (2)

Caregiver-guided pain management training protocol (CG-PMT)

ACTIVE COMPARATOR

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)

Enhanced treatment-as-usual (TAU)

ACTIVE COMPARATOR

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)

Interventions

Caregiver-guided pain management training (CG-PMT)BEHAVIORAL

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.

Caregiver-guided pain management training protocol (CG-PMT)
Enhanced treatment-as-usual (TAU)BEHAVIORAL

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.

Enhanced treatment-as-usual (TAU)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis Stage 4 solid or hematologic malignancy and nonresectable Stage 3 gastrointestinal (GI) cancer
  • life expectancy of \< 1 month
  • worst pain in the past 2 weeks greater than or equal to 4 on the 0-10 pain scale,
  • have an identified caregiver who is also willing to participate,
  • at least 18 years old, 6) fluent in English.
  • at least 18 years old
  • fluent in English

You may not qualify if:

  • Palliative Performance Scale rating \<40,
  • current external radiation therapy for reduction of pain
  • unable to provide informed consent or complete study procedures as determined by clinical or study staff.
  • \) unable to provide informed consent or complete study procedures as determined by clinical or study staff.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (2)

  • Porter LS, Steel JL, Fairclough DL, LeBlanc TW, Bull J, Hanson LC, Fischer S, Keefe FJ. Caregiver-guided pain coping skills training for patients with advanced cancer: Results from a randomized clinical trial. Palliat Med. 2021 May;35(5):952-961. doi: 10.1177/02692163211004216. Epub 2021 Mar 29.

    PMID: 33775175DERIVED

  • Porter LS, Samsa G, Steel JL, Hanson LC, LeBlanc TW, Bull J, Fischer S, Keefe FJ. Caregiver-guided pain coping skills training for patients with advanced cancer: Background, design, and challenges for the CaringPals study. Clin Trials. 2019 Jun;16(3):263-272. doi: 10.1177/1740774519829695. Epub 2019 Feb 19.

    PMID: 30782014DERIVED

Study Officials

  • Laura Porter, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2015

First Posted

April 30, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2018

Study Completion

October 4, 2019

Last Updated

August 25, 2023

Record last verified: 2023-08

Locations

US(1)