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Recruiting NCT07300995

Behavioral Pain Intervention for Older Cancer Patients

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pain Coping Skills Training (PCST).
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral Pain Coping Skills Training (PCST)
    Behavioral pain intervention delivered via telehealth.

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Self-Efficacy for Pain Management [Time frame: Baseline, 10-week assessment, 15-week assessment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Duke Cancer Network — Durham

Identifiers

NCT: NCT07300995 · Pro00117948 · P30AG022845

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗