Breast CancerNCT04049214
Perioperative Mindfulness Proposal
A study testing Meditation in people with Breast Cancer and DCIS, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, DCIS
- What is being tested?
- Meditation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2019to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Melinda Epstein, PhD, 949-764-5543, clinicalresearch@hoag.org
About this study
Official title: Feasibility Study to Determine the Effect of Meditation on Perioperative Pain and Distress in Newly Diagnosed Breast Cancer Patients
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.
Read the detailed description
Breast cancer affects 1 in 8 women in the United States and the majority are managed surgically as part of their primary treatment. Annually over 800 women at Hoag are treated surgically for breast cancer.
Anxiety and fear are commonly associated with breast cancer diagnosis, with as many as 20% of breast cancer patients suffering from full blown depressive disorder and 10% from an anxiety disorder.(1) Mindfulness practices have demonstrated improvements in self reported well being, reductions in stress and fatigue, reduced reactivity to distressing thoughts and improvements in both sensory and affective pain components in a variety of chronic pain conditions including arthritis and chronic pain syndromes. (2) Adoption of Mindfulness Based Stress Reduction (MBSR) has shown improvements in psychological health for breast cancer survivors, (3) but significant reductions in pain levels have not been demonstrated. The limitations of MBSR (Mindfulness Based Stress Reduction) include significant time investment for patients as well as time and cost of care providers and health care systems. The effect of meditation and specific yogic breath work practices on pain has not been studied.
Opioid addiction is a growing social problem. In 2016 over 2 million Americans over the age of 12 were estimated to suffer from addiction to prescription pain medications, leading to over 20,000 overdose related deaths. (4) The majority of these patients were women. Indicated use narcotic exposure has been reported as an initiation event for some patients in the development of opioid addiction, with over 5% of patients who initiated prescription pain medication at the time of surgery continuing to use the medications after the acute surgical process has resolved. (5) We propose to study the effect of meditation and breath work practice on the distress and perioperative pain of breast cancer patients undergoing primary surgical treatment for breast cancer. The benefit of meditation and breath work practice over standard MBSR practice includes lower burden on patients of time and therefore higher potential cost effectiveness and long term sustainability of patients adopting and committing to a regular practice. The breath work and specific meditation practices that will be taught could be a novel method to address perioperative pain, plus improve management of anxiety and stress during this period and beyond. If successful, this pre recorded meditation guidance that patients can utilize in home practice could be a cost effective addition to improve overall perioperative patient experience.
- Conditions
- Breast Cancer, DCIS
- Being tested
- Meditation
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Meditation | Other | 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. Receives: Other: Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start31 Jul 2019
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoag Memorial Hospital Presbyterian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049214
- Sponsor's protocol ID
- 173-18-CA
- Status last verified
- Oct 2024
- First submitted
- 31 Jul 2019
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Determine the Effect of Meditation on Perioperative Pain and Distress in Newly Diagnosed Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04049214
- Acronym / sponsor ID
- 173-18-CA
- Conditions
- Breast Cancer, DCIS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hoag Memorial Hospital PresbyterianUniversity, hospital or other
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breast cancer affects 1 in 8 women in the United States and the majority are managed surgically as part of their primary treatment. Annually over 800 women at Hoag are treated surgically for breast cancer.
Anxiety and fear are commonly associated with breast cancer diagnosis, with as many as 20% of breast cancer patients suffering from full blown depressive disorder and 10% from an anxiety disorder.(1) Mindfulness practices have demonstrated improvements in self reported well being, reductions in stress and fatigue, reduced reactivity to distressing thoughts and improvements in both sensory and affective pain components in a variety of chronic pain conditions including arthritis and chronic pain syndromes. (2) Adoption of Mindfulness Based Stress Reduction (MBSR) has shown improvements in psychological health for breast cancer survivors, (3) but significant reductions in pain levels have not been demonstrated. The limitations of MBSR (Mindfulness Based Stress Reduction) include significant time investment for patients as well as time and cost of care providers and health care systems. The effect of meditation and specific yogic breath work practices on pain has not been studied.
Opioid addiction is a growing social problem. In 2016 over 2 million Americans over the age of 12 were estimated to suffer from addiction to prescription pain medications, leading to over 20,000 overdose related deaths. (4) The majority of these patients were women. Indicated use narcotic exposure has been reported as an initiation event for some patients in the development of opioid addiction, with over 5% of patients who initiated prescription pain medication at the time of surgery continuing to use the medications after the acute surgical process has resolved. (5) We propose to study the effect of meditation and breath work practice on the distress and perioperative pain of breast cancer patients undergoing primary surgical treatment for breast cancer. The benefit of meditation and breath work practice over standard MBSR practice includes lower burden on patients of time and therefore higher potential cost effectiveness and long term sustainability of patients adopting and committing to a regular practice. The breath work and specific meditation practices that will be taught could be a novel method to address perioperative pain, plus improve management of anxiety and stress during this period and beyond. If successful, this pre recorded meditation guidance that patients can utilize in home practice could be a cost effective addition to improve overall perioperative patient experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meditation | Other | Other: MeditationTwo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeditationTwo 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. | Other | Meditation |
Primary outcome
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)
Time frame: 12 weeks
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation in people with Breast Cancer and DCIS, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melinda Epstein, PhD (949-764-5543, clinicalresearch@hoag.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.