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Completed

NCT Number: NCT02067351

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant
  • Practicing mindfulness

Treatment and study plan

Mindfulness

Behavioral

Meditation, body scan, yoga.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Stress - measured by the Perceived Stress Scale - statistically and clinically significant reductions in stress

    Time frame: 7-8 months

    Stress will be measured before the start of chemotherapy, monthly while receiving chemotherapy (usually 4-5 months) and at 3 months after chemotherapy

Other outcomes

  1. Fatigue - Multidimensional Fatigue Symptom Inventory -Short Form statistically and clinically significant reductions in fatigue score

    Time frame: 7-8 months

    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

  2. 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

    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

  3. Sleep measured by the Pittsburgh Sleep Quality Index -statistically and clinically significant improvements in sleep

    Time frame: 7-8 months

    Sleep will be measured before the start of chemotherapy, monthly while receiving chemotherapy (usually 4-5 months) and at 3 months after chemotherapy

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 20, 2014
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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