Clinical trial · Interventional
Caregiver-Guided Pain Management Training in Palliative Care
NCT02430467CI-TRIAL-00069075completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Caregiver-guided pain management training (CG-PMT) | Behavioral | — | UNRESOLVED |
| Enhanced treatment-as-usual (TAU) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Caregiver-guided pain management training protocol (CG-PMT)
- description
- 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
- interventionNames
- Behavioral: Caregiver-guided pain management training (CG-PMT)
- type
- ACTIVE_COMPARATOR
- label
- Enhanced treatment-as-usual (TAU)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDPorter 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 33775175
- DERIVEDPorter 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 30782014