Breast CancerNCT07300995
Behavioral Pain Intervention for Older Cancer Patients
A study testing Pain Coping Skills Training (PCST) in people with Breast Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pain Coping Skills Training (PCST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participation in the last 6 months in a pain coping skills training program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke Cancer Network
Durham, North Carolina, 27713
Tamara Somers
Tamara Somers, PhD
About this study
Official title: Brief Pain Coping Skills Training for Older Women With Breast Cancer and Pain: An Efficacy-Effectiveness Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Pain Coping Skills Training (PCST)
- Keywords
- cancer, pain, coping, symptom management
- Medical subject headings
- Breast Neoplasms, Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Coping Skills Training (PCST)Behavioural
Behavioral pain intervention delivered via telehealth.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 10-week assessment, 15-week assessment
Secondary outcomes (1)
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.
Measured: Baseline, 10-week assessment, 15-week assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start17 Jun 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Duke University
- Responsible party
- Sponsor
- Investigators
- Cary Reid, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300995
- Sponsor's protocol ID
- Pro00117948
- Other IDs
- P30AG022845
- Status last verified
- Aug 2026
- First submitted
- 22 Dec 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Pain Coping Skills Training for Older Women With Breast Cancer and Pain: An Efficacy-Effectiveness Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07300995
- Acronym / sponsor ID
- Pro00117948
- Conditions
- Breast Cancer
- Keywords
- cancer, pain, coping, symptom management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Duke University
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Coping Skills Training | Experimental | Behavioral: Pain Coping Skills Training (PCST)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). |
| 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). |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Participation in the last 6 months in a pain coping skills training program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Coping Skills Training (PCST)Behavioral pain intervention delivered via telehealth. | Behavioural | Pain Coping Skills Training |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Self-Efficacy for Pain Management
Time frame: Baseline, 10-week assessment, 15-week assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cary Reid, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Coping Skills Training (PCST) in people with Breast Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tamara Somers, PhD (919-416-3408, tamara.somers@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity as measured by the Brief Pain Inventory (BPI) (time frame: Baseline, 10-week assessment, 15-week assessment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.