Recruiting

PCST

Sponsor:

Weill Medical College of Cornell University

Code:

NCT07300995

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Pain Coping Skills Training (PCST)

Study Details

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

Study ID

NCT07300995

Start date

Jun 17, 2026

Status verified date

Aug, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 55+

Healthy Volunteers: Not accepted

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 Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Pain Coping Skills Training

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).

no intervention: Usual Care

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 pain intervention delivered via telehealth.

Primary outcome measure

  • Pain severity as measured by the Brief Pain Inventory (BPI) [ Time Frame: Baseline, 10-week assessment, 15-week assessment ]
  • Pain interference as measured by the Brief Pain Inventory (BPI) [ 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 [ 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 [ Time Frame: Baseline, 10-week assessment, 15-week assessment ]

Central Contacts and Locations

Central contacts

Tamara Somers, PhD

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

Locations

Duke Cancer Network

Recruiting

Durham, North Carolina, United States, 27713

Principal Investigator:

Tamara Somers, PhD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • cancer
  • pain
  • coping
  • symptom management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-08-12.