Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy

NCT02067351 | Completed Phase 2

• 1 other identifier: 13-008531
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

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)

  While receiving chemotherapy (usually 4-5 months)

Secondary Outcomes (1)

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

  7-8 months

Other Outcomes (3)

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

  7-8 months

• Quality of life measured by the Functional Assessment of Cancer Therapy - Breast - statistically and clinically significant improvement in quality of life

  7-8 months

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

  7-8 months

Study Arms (1)

Mindfulness Intervention

EXPERIMENTAL

Mindfulness intervention

Behavioral: Mindfulness

Interventions

Mindfulness BEHAVIORAL

Meditation, body scan, yoga.

Mindfulness Intervention

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant
• Practicing mindfulness

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Daniela Stan, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Daniela Stan, MD

Study Record Dates

• First Submitted: February 15, 2014
• First Posted: February 20, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 3, 2020

Record last verified: 2020-02

Locations

US (1)