Clinical trial NCT02430467: Caregiver-Guided Pain Management Training in Palliative Care
Official title: Caregiver-Guided Pain Management Training in Palliative Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Palliative Care Research Cooperative Group
First posted: 2015-04-30
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Change in caregiver self-efficacy for helping the patient manage pain
timeFrame: baseline, post-intervention (3 weeks)
Secondary outcomes:
measure: Change in caregiver strain
timeFrame: baseline, following intervention (3 weeks)
measure: Change in caregiver satisfaction
timeFrame: baseline, following intervention (3 weeks)
measure: Change in caregiver psychological distress
timeFrame: baseline, following intervention (3 weeks)
measure: Change in caregiver psychological distress
timeFrame: following death of patient (3 mos & 6 mos)
measure: Change in caregiver health behaviors
timeFrame: following death of patient (3 mos & 6 mos)
measure: Change in caregiver global health rating
timeFrame: following death of patient (3 mos & 6 mos)
measure: Change in patient pain
timeFrame: baseline, post-intervention (3 weeks)
measure: Change in patient self-efficacy
timeFrame: baseline, post-intervention (3 weeks)
measure: Change in patient psychological distress
timeFrame: baseline, post-intervention (3 weeks)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Laura Porter, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.