Breast Cancer
Conditions
Keywords
cancer, pain, coping, symptom management
Brief 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.
Interventions
BEHAVIORALPain Coping Skills Training (PCST)
Behavioral pain intervention delivered via telehealth.
Sponsors
Weill Medical College of Cornell University
National Institute on Aging (NIA)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain severity as measured by the Brief Pain Inventory (BPI) | Baseline, 10-week assessment, 15-week assessment | 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. |
| Pain interference as measured by the Brief Pain Inventory (BPI) | Baseline, 10-week assessment, 15-week assessment | 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. |
| 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 | 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. |
| Health Related Quality of Life (HR-QOL) as measured by the Patient Reported Outcomes Measurement Information System (PROMIS-29) - Mental Health | Baseline, 10-week assessment, 15-week assessment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Efficacy for Pain Management | Baseline, 10-week assessment, 15-week assessment | The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item scale rating confidence (0-6) in specific tasks despite pain. The total score ranges from 0 to 60, where higher scores indicate greater self-efficacy. |
Countries
United States
Contacts
CONTACTTamara Somers, PhD
PRINCIPAL_INVESTIGATORCary Reid, MD, PhD
Weill Medical College of Cornell University
Outcome results
None listed