Perioperative Mindfulness Proposal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHoag Memorial Hospital Presbyterian
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Recurrent breast cancer
Current or history of major psychiatric diagnosis.
Subjects who are receiving neo-adjuvant chemotherapy
Subjects undergoing modified radical mastectomy or reconstruction
Trial design
Design model
Single group
Treatments tested in this trial
Meditation
Other interventionTwo 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.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: MeditationOther 1 intervention
Trial outcomes
Primary outcomes
1
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)
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)
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov