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NCT Number: NCT02430467

Caregiver-Guided Pain Management Training in Palliative Care

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.

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Key information

Conditions

Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patient Inclusion Criteria:

  • 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.

Caregiver Inclusion Criteria:

  • at least 18 years old
  • fluent in English

Patient Exclusion Criteria:

  • 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.

Caregiver Exclusion Criteria:

  • unable to provide informed consent or complete study procedures as determined by clinical or study staff.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: baseline, post-intervention (3 weeks)

    Caregiver Self-Efficacy Scale

Secondary outcomes

  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 (3 mos & 6 mos)

    Trait Anxiety Scale

  5. Change in caregiver health behaviors

    Time frame: following death of patient (3 mos & 6 mos)

    Self-Administered Comorbidity Questionnaire

  6. Change in caregiver global health rating

    Time frame: following death of patient (3 mos & 6 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

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

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Apr 30, 2015
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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