RecruitingRecruiting
Behavioral Pain Intervention for Older Cancer Patients
NCT07300995 · Duke University
In plain English
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Official title
Brief Pain Coping Skills Training for Older Women With Breast Cancer and Pain: An Efficacy-Effectiveness Randomized Controlled Trial
About this study
Pain continues to be persistent, interfering, and distressing for women with breast cancer. Behavioral cancer pain interventions continue to be poorly implemented with pronounced disparities for older breast cancer patients receiving oncology care in medically underserved areas. Within this context, this randomized controlled trial examines a 1-session, telehealth pain coping skills training (PCST) protocol with five 15-minute maintenance calls (Brief PCST-Community) adapted for women with breast cancer in medically underserved areas. Pain, health-related quality of life, and self-efficacy for pain management will be assessed at baseline and 10 and 15 weeks later.
Eligibility criteria
Inclusion Criteria:
* Receiving cancer care at a Duke Cancer Network (DCN) clinic
* Stage I-IV breast cancer
* Self-reported pain on at least 10 days in the last month and pain rating of worst pain of 4 or greater on a 0-10 scale in the last week
* Biologically female
* Greater than or equal to 55 years old
* Ability to speak and read English
* Hearing and vision that allows for successful completion of videoconferencing and phone session
Exclusion Criteria:
* Participation in the last 6 months in a pain coping skills training program
Study design
Enrollment target: 168 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-06-30
Estimated completion: 2027-06-01
Last updated: 2026-06-02
Interventions
Behavioral: Pain Coping Skills Training (PCST)
Primary outcomes
- • Pain severity as measured by the Brief Pain Inventory (BPI) (Baseline, 10-week assessment, 15-week assessment)
- • Pain interference as measured by the Brief Pain Inventory (BPI) (Baseline, 10-week assessment, 15-week assessment)
- • Health Related Quality of Life (HR-QOL) as measured by the Patient Reported Outcomes Measurement Information System (PROMIS-29) - Physical Function (Baseline, 10-week assessment, 15-week assessment)
Sponsor
Duke University · other
With: National Institute on Aging (NIA)
Contacts & investigators
ContactTamara Somers, PhD · contact · tamara.somers@duke.edu · 919-416-3408
All locations (1)
Duke Cancer NetworkRecruiting
Durham, North Carolina, United States