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Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Daniela L. Stan, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02067351
First received: February 15, 2014
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Behavioral: Mindfulness
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Feasibility - percentage of patients recruited from those approached, percentage of patients who dropped off, percentage of patients who are compliant (attending more than 75% of recommended sessions) [ Time Frame: While receiving chemotherapy (usually 4-5 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stress - measured by the Perceived Stress Scale - statistically and clinically significant reductions in stress [ Time Frame: 7-8 months ] [ Designated as safety issue: No ]
    Stress will be measured before the start of chemotherapy, monthly while receiving chemotherapy (usually 4-5 months) and at 3 months after chemotherapy


Other Outcome Measures:
  • Fatigue - Multidimensional Fatigue Symptom Inventory -Short Form statistically and clinically significant reductions in fatigue score [ Time Frame: 7-8 months ] [ Designated as safety issue: No ]
    Fatigue will be measured by the before the start of chemotherapy, monthly while receiving chemotherapy (usually 4-5 months) and at 3 months after chemotherapy

  • Quality of life measured by the Functional Assessment of Cancer Therapy - Breast - statistically and clinically significant improvement in quality of life [ Time Frame: 7-8 months ] [ Designated as safety issue: No ]
    Quality of life will be measured before the start of chemotherapy, monthly while receiving chemotherapy (usually 4-5 months) and at 3 months after chemotherapy

  • Sleep measured by the Pittsburgh Sleep Quality Index -statistically and clinically significant improvements in sleep [ Time Frame: 7-8 months ] [ Designated as safety issue: No ]
    Sleep will be measured before the start of chemotherapy, monthly while receiving chemotherapy (usually 4-5 months) and at 3 months after chemotherapy


Estimated Enrollment: 25
Study Start Date: April 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness Intervention
Mindfulness intervention
Behavioral: Mindfulness
Meditation, body scan, yoga.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

inclusion criteria:

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

Exclusion criteria

  • Pregnant
  • Practicing mindfulness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02067351

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Daniela Stan, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Daniela L. Stan, M.D., Principal Investigator, Daniela Stan, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02067351     History of Changes
Other Study ID Numbers: 13-008531
Study First Received: February 15, 2014
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 24, 2014