RecruitingInterventional

Brief Pain Coping Skills Training for Older Women With Breast Cancer and Pain: An Efficacy-Effectiveness Randomized Controlled Trial

NCT ID: NCT07300995Sponsor: Duke UniversityLast updated: 2026-06-02

Summary

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.

Detailed description

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.

Arms & interventions

BehavioralPain Coping Skills Training (PCST)
Behavioral pain intervention delivered via telehealth.

Outcome measures

Primary

Pain severity as measured by the Brief Pain Inventory (BPI)
BPI Pain Severity (worst, least, average, current pain on 0-10 scale) scores are averaged for a total score range of 0 to 10, with higher scores indicating greater pain severity.
Time frame: Baseline, 10-week assessment, 15-week assessment
Pain interference as measured by the Brief Pain Inventory (BPI)
BPI Pain Interference (7 daily life areas such as mood, sleep, activity rated 0-10) scores are averaged for a total score range of 0 to 10, with higher scores indicating greater pain interference.
Time frame: 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
A PROMIS Physical Function T-score is a standardized number (mean 50, SD 10) from the Patient-Reported Outcomes Measurement Information System (PROMIS) that reflects self-reported physical ability with higher scores indicating better function.
Time frame: 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) - Mental Health
A PROMIS Mental Health T-score is a standardized number (mean 50, SD 10) from the Patient-Reported Outcomes Measurement Information System (PROMIS) that reflects self-reported mental health with higher scores indicating worse mental health.
Time frame: Baseline, 10-week assessment, 15-week assessment

Secondary

Self-Efficacy for Pain Management
Time frame: Baseline, 10-week assessment, 15-week assessment

Eligibility criteria

Sex: FemaleAge: 55 Years and olderHealthy volunteers: No

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 locations (1)

Duke Cancer Network

Durham, North Carolina, 27713

Recruiting

Tamara Somers · Contact