Acupressure for Pain and Opioid Use Among Breast Cancer Patients (NCT03655600) | Clinical Trial Compass
TerminatedNot Applicable
Acupressure for Pain and Opioid Use Among Breast Cancer Patients
Stopped: Difficulty recruiting and retaining participants
United States8 participantsStarted 2018-09-17
Plain-language summary
This study seeks to determine the feasibility of recruiting and training participants in self-acupressure, for women undergoing primary breast cancer surgery or delayed reconstruction surgery. The study seeks to determine also if self-acupressure is effective in reducing the need for opioids post-surgery and the effects on other life factors.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Diagnosis of breast cancer stage 0 to III;
✓. Planned unilateral or bilateral mastectomy or planned delayed breast reconstruction surgery within 24 months following unilateral or bilateral mastectomy;
✓. For delayed breast reconstruction patients only: apparently cancer free at time of delayed reconstruction;
✓. No planned new interventions for pain the two weeks prior to surgery;
✓. Able to self-administer treatment at the specified points.
Exclusion criteria
✕. Medically unstable (e.g. uncontrolled diabetes, high blood pressure, etc.);
✕. For delayed breast reconstruction only: taking aromatase inhibitors which could confound surgical and chronic pain measurements;
✕. Have a diagnosis of untreated mood disorder, e.g., bipolar or major depressive disorder;
✕. Unwilling to maintain stable does of allowed chronic pain medications (e.g. NSAIDS, benzodiazepines, SSRIs and SNRIs);
What they're measuring
1
Feasibility of recruitment for self-acupressure: Measure screening to on-study ratio of participants
Timeframe: 14 days
2
Feasibility of training, as measured by number of participants who complete the daily self-reported logbook
Timeframe: 28 days
3
Feasibility of training for self-acupressure: Measure the fidelity (accuracy) of participants using training application via instrument administered by study team
✕. Pregnant, those planning a pregnancy, or lactating mothers;
✕. Any medical condition or treatment factor that the study team feels would either compromise the data acquired or introduce a potential safety concern.
✕. Unable to give consent;
✕. Acupuncture or acupressure receipt in past year