Clinical trial · Interventional
Perioperative Mindfulness Proposal
Feasibility Study to Determine the Effect of Meditation on Perioperative Pain and Distress in Newly Diagnosed Breast Cancer Patients
NCT04049214CI-TRIAL-00081592recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if a regular meditation and breath work practice started before surgery and continued through post-surgical recovery can improve anxiety and pain related to breast cancer and its treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| DCIS | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Meditation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Meditation
- description
- Two guided meditations will be provided to participants. They will be asked to meditate twice daily, once in the morning once before bed, for a total time of 12 minutes per day. Surgical treatment and postoperative care will be provided by surgeon preference and usual practice, including post-operative pain medications. For 12 weeks patients will maintain a daily meditation log, medication log and complete daily pain assessment questionnaire.
- interventionNames
- Other: Meditation
Primary outcomes (1)
- measure
- Will daily meditation change pain in undergoing primary surgical treatment for newly diagnosed breast cancer, utilizing the MD Anderson Cancer Center Brief Pain Inventory (short form)
- timeFrame
- 12 weeks
- description
- Baseline pain assessment will be administered after informed consent is obtained. One week before definitive breast cancer surgery research subjects will complete a one on one education session regarding meditation practice with a wellness coach (AW), and complete a baseline NCCN distress survey. They will begin a daily meditation practice. Two guided meditations will be provided to participants. They will be asked to meditate twice daily, once in the morning once before bed, for a total time of 12 minutes per day. Surgical treatment and postoperative care will be provided by surgeon preference and usual practice, including post-operative pain medications. For 12 weeks patients will maintain a daily meditation log, medication log and complete daily pain assessment questionnaire using the MD Anderson Cancer Center Brief Pain Inventory (short form)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Females 18 years of age or older * Subject must be able to speak and read English * Newly diagnosed with primary breast cancer * Will receive primary surgical treatment for their breast cancer diagnosis. * Undergoing lumpectomy with or without autologous reconstruction with or without contralateral surgery for symmetry with or without IORT or simple mastectomy without reconstruction * Breast cancer or DCIS Exclusion Criteria: * Recurrent breast cancer * Current or history of major psychiatric diagnosis. * Subjects who are receiving neo-adjuvant chemotherapy * Subjects undergoing modified radical mastectomy or reconstruction * Subjects regular meditation practice within the past 12 months (defined as greater than twice weekly practice) * Subjects unwilling or unable to complete study materials or comply with study visits * Subjects with no access to email or a mobile phone (required to access meditations) * Subjects undergoing surgery outside Hoag * Subjects who have narcotic dependence as defined by regular weekly narcotic use before cancer diagnosis. * Re-excision after lumpectomy (subjects who require re-excision after initial enrollment will be excluded from final analysis and dropped from the study).
References
Publications (0)
Data not yet available
No reference posted for this study.