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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will study if meditation and breathwork can help ease anxiety and pain related to breast cancer and its treatment.
Who is the study for?
This trial is for English-speaking women aged 18 or older who are newly diagnosed with primary breast cancer or DCIS and will receive surgical treatment. They must not have a major psychiatric history, narcotic dependence, regular meditation practice in the past year, or be undergoing certain complex surgeries.Check my eligibility
What is being tested?
The study tests if practicing meditation and breath work before and after surgery can reduce anxiety and pain in patients dealing with breast cancer treatments. Participants will start meditating before their surgery and continue during recovery.See study design
What are the potential side effects?
Since the intervention involves meditation practices rather than medication, no traditional side effects are expected. However, participants may experience varying levels of relaxation or emotional responses to mindfulness exercises.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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)
Trial Design
1Treatment groups
Experimental Treatment
Group I: MeditationExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Hoag Memorial Hospital PresbyterianLead Sponsor
34 Previous Clinical Trials
14,671 Total Patients Enrolled
2 Trials studying Breast Cancer
324 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have or have had a serious mental health diagnosis.You are going to have surgery as the first treatment for your breast cancer.You are currently receiving chemotherapy before surgery.You are having surgery to remove breast cancer, with or without reconstruction.You have practiced meditation more than twice a week in the past year.You regularly used narcotics before being diagnosed with cancer.You are having surgery to remove a breast and possibly having reconstruction.You have breast cancer that has come back after treatment.You have breast cancer or ductal carcinoma in situ (DCIS).You have been recently diagnosed with breast cancer for the first time.
Research Study Groups:
This trial has the following groups:- Group 1: Meditation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollees being welcomed into this investigation?
"According to the clinicaltrials.gov, this medical experiment is actively seeking patients for participation. It was initially shared on July 31st 2019 and most recently updated on August 22nd 2022."
Answered by AI
How many participants are being administered treatment in this research endeavor?
"Affirmative. Clinicaltrials.gov reveals that this medical research, which was first published on July 31st 2019, is actively searching for participants. Recruitment needs to be conducted for 24 patients from a single site."
Answered by AI
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