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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

February 15, 2014
February 20, 2014
April 2014
April 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT02067351 on ClinicalTrials.gov Archive Site
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
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 (ussually 4-5 months) and at 3 months after chemotherapy
  • 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
  • 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 (ussually 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 (ussually 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 (ussually 4-5 months) and at 3 months after chemotherapy
 
Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy
Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Breast Cancer
Behavioral: Mindfulness
Meditation, body scan, yoga.
Experimental: Mindfulness Intervention
Mindfulness intervention
Intervention: Behavioral: Mindfulness
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
25
April 2015
April 2015   (final data collection date for primary outcome measure)

inclusion criteria:

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

Exclusion criteria

  • Pregnant
  • Practicing mindfulness
Female
20 Years to 75 Years
Yes
United States
 
NCT02067351
13-008531
No
Daniela L. Stan, M.D., Principal Investigator, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Daniela Stan, MD Mayo Clinic
Mayo Clinic
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP