Caregiver-Guided Pain Management Training in Palliative Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Caregiver-Guided Pain Management Training in Palliative Care

Conditions
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Advanced Cancer

Intervention / Treatment
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* Behavioral: Caregiver-guided pain management training (CG-PMT)
* Behavioral: Enhanced treatment-as-usual (TAU)


Participation Criteria
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Eligibility Criteria
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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: 1) unable to provide informed consent or complete study procedures as determined by clinical or study staff.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caregiver-guided pain management training protocol (CG-PMT)<br>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)<br>* 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.<br>|
| Active Comparator: Enhanced treatment-as-usual (TAU)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in caregiver self-efficacy for helping the patient manage pain | Caregiver Self-Efficacy Scale | baseline, post-intervention (3 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in caregiver strain | Caregiver Strain Index | baseline, following intervention (3 weeks) | 
| Change in caregiver satisfaction | Caregiving Satisfaction Scale | baseline, following intervention (3 weeks) | 
| Change in caregiver psychological distress | Center for Epidemiology Studies Short Depression Scale | baseline, following intervention (3 weeks) | 
| Change in caregiver psychological distress | Trait Anxiety Scale | following death of patient (3 mos & 6 mos) | 
| Change in caregiver health behaviors | Self-Administered Comorbidity Questionnaire | following death of patient (3 mos & 6 mos) | 
| Change in caregiver global health rating | Global health rating | following death of patient (3 mos & 6 mos) | 
| Change in patient pain | Brief Pain Inventory | baseline, post-intervention (3 weeks) | 
| Change in patient self-efficacy | Patient Self-Efficacy Scale | baseline, post-intervention (3 weeks) | 
| Change in patient psychological distress | Hospital Anxiety and Depression Scale | baseline, post-intervention (3 weeks) |