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NCT Number: NCT07300995

Behavioral Pain Intervention for Older Cancer Patients

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke Cancer Network

Durham, North Carolina, 27713, United States

Location status: Recruiting

Location contact

Tamara Somers

CONTACT

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pain Coping Skills Training (PCST)

Behavioral

Behavioral pain intervention delivered via telehealth.

Primary outcomes

  1. Pain severity as measured by the Brief Pain Inventory (BPI)

    Time frame: 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.

  2. Pain interference as measured by the Brief Pain Inventory (BPI)

    Time frame: 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.

  3. Health Related Quality of Life (HR-QOL) as measured by the Patient Reported Outcomes Measurement Information System (PROMIS-29) - Physical Function

    Time frame: 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.

  4. Health Related Quality of Life (HR-QOL) as measured by the Patient Reported Outcomes Measurement Information System (PROMIS-29) - Mental Health

    Time frame: 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 outcomes

  1. Self-Efficacy for Pain Management

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tamara Somers, PhD

CONTACT

[email protected]

919-416-3408

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 24, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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