Behavioral Pain Intervention for Older Cancer Patients

NCT07300995 | Not Yet Recruiting

• 2 other identifiers: Pro00117948P30AG022845
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

cancer; pain; coping; symptom management

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Self-Efficacy for Pain Management

  Baseline, 10-week assessment, 15-week assessment

Study Arms (2)

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).

Behavioral: Pain Coping Skills Training (PCST)

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).

Interventions

Pain Coping Skills Training (PCST) BEHAVIORAL

Behavioral pain intervention delivered via telehealth.

Pain Coping Skills Training

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participation in the last 6 months in a pain coping skills training program

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms; Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Tamara Somers, PhD

CONTACT

919-416-3408; tamara.somers@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: December 24, 2025
• Study Start: April 6, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share