This randomized clinical trial studies a caregiver-guided pain management training intervention in reducing suffering in patients with cancer that has spread to other places in the body and improving self-efficacy in caregivers. A caregiver-guided pain management training intervention may help patients and their caregivers cope with cancer pain.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02430467.
PRIMARY OBJECTIVES:
I. 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 OBJECTIVES:
I. Testing the efficacy of the Caregiver-Guided Pain Management Training (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.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I (CG-PMT): Participants receive 3 Caregiver-Guided Pain Management Training sessions over 60 minutes via Skype videoconference software on iPads with a 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.
ARM II (ENHANCED TREATMENT-AS-USUAL): Participants receive an educational video on cancer pain and its management. They also receive iPads with icons linked to an American Cancer Society website that provides educational information on pain and are encouraged to use them for information and support.
QUALITATIVE PILOT STUDY: Participants with gastric cancer participate in an interview over 60 minutes.
After completion of study, caregivers are followed up at 3 and 6 months after patient death.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDuke University Medical Center
Principal InvestigatorLaura Porter