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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG022845 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain Coping Skills Training | Experimental | Participants in this group will complete a 50-minute telehealth session with a trained study nurse. During this session, they will be taught how to use several coping strategies for managing pain. This will be followed by 5 weekly, 15-minute supportive phone calls, where the study nurse will reinforce the learned coping skills. They will be asked to complete 2 follow-up surveys (10 weeks and 15 weeks after the first survey). |
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| Usual Care | No Intervention | Participants in this group will not complete the new program. They will be asked to complete 2 follow-up surveys (10 and 15 weeks after the first survey). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain Coping Skills Training (PCST) | Behavioral | Behavioral pain intervention delivered via telehealth. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Baseline, 10-week assessment, 15-week assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Efficacy for Pain Management | 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. | Baseline, 10-week assessment, 15-week assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tamara Somers, PhD | Contact | 919-416-3408 | tamara.somers@duke.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
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| Duke Cancer Network | Recruiting | Durham | North Carolina | 27713 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |