Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy

NCT ID: NCT02067351

Last Updated: 2020-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-01-31

Brief Summary

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There is evidence that mindfulness-based interventions (MBIs) such as meditation, mindfulness-based stress reduction (MBSR) and yoga might improve Quality of Life (QOL) and reduce stress in breast cancer survivors. These interventions are becoming increasingly popular in cancer survivors. However, little is known about the feasibility and effect of MBIs administered during the interval of time of chemotherapy, on QOL and stress. The investigators are planning a MBI intervention study developed specifically for breast cancer survivors receiving chemotherapy (usually 4-5 months) at the investigators institution, for at least 8 sessions combined with at least 8 weeks of home-practice, in 25 women receiving chemotherapy for breast cancer.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Mindfulness Intervention

Mindfulness intervention

Group Type EXPERIMENTAL

Mindfulness

Intervention Type BEHAVIORAL

Meditation, body scan, yoga.

Interventions

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Mindfulness

Meditation, body scan, yoga.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Women 20-75 years old
* Diagnosed with breast cancer
* Scheduled to begin chemotherapy at Mayo Clinic Rochester

Exclusion Criteria

* Pregnant
* Practicing mindfulness
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Daniela L. Stan, M.D

Daniela Stan, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniela Stan, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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13-008531

Identifier Type: -

Identifier Source: org_study_id

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