This clinical trial compares a targeted pain coping skills training (Targeted-PCST) intervention to a general health intervention and an educational materials intervention for the management of persistent pain in patients who underwent a mastectomy for stage 0-III breast cancer. Persistent pain can have a negative impact on emotional and physical functioning, but it has no satisfactory pharmacological treatment options. The Targeted-PCST intervention targets women with persistent pain and trains them on pain coping skills to reduce pain and distress. This clinical trial compares the Targeted-PCST intervention to two educational interventions for the management of persistent pain in women who underwent a mastectomy for breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT04225585.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Investigate the impact of Targeted-PCST on persistent pain (PP) following breast cancer surgery.
II. Examine the impact of Targeted-PCST on pain catastrophizing, self-efficacy, and psychological inflexibility, and explore these variables as mediators of the impact of Targeted-PCST on persistent pain severity and interference following breast cancer surgery.
III. Examine the impact of Targeted-PCST on pain sensitivity and central sensitization, and explore their roles as mediators of the impact of Targeted-PCST on persistent pain severity and interference.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive the Targeted-PCST intervention via videoconference over 45-60 minutes weekly for 8 weeks.
ARM II: Patients receive the general health education intervention via videoconference over 45-60 minutes weekly for 8 weeks.
ARM III: Patients receive print educational materials.
After completion of study intervention, patients are followed up at 6 and 12 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDuke University Medical Center
Principal InvestigatorRebecca Shelby