Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy

Breast Cancer Clinical Trial

Official title:

Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02067351
• Other study ID #: 13-008531
• Status: Completed
• Phase: Phase 2
• Start date: April 2014
• Est. completion date: January 2017

Study information

• Verified date: February 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

inclusion criteria:

• Women 20-75 years old

• Diagnosed with breast cancer

• Scheduled to begin chemotherapy at Mayo Clinic Rochester

Exclusion criteria

• Pregnant

• Practicing mindfulness

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Mindfulness
Meditation, body scan, yoga.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fatigue - Multidimensional Fatigue Symptom Inventory -Short Form statistically and clinically significant reductions in fatigue score	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	7-8 months
Other	Quality of life measured by the Functional Assessment of Cancer Therapy - Breast - statistically and clinically significant improvement in quality of life	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	7-8 months
Other	Sleep measured by the Pittsburgh Sleep Quality Index -statistically and clinically significant improvements in sleep	Sleep will be measured before the start of chemotherapy, monthly while receiving chemotherapy (usually 4-5 months) and at 3 months after chemotherapy	7-8 months
Primary	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	Stress - measured by the Perceived Stress Scale - statistically and clinically significant reductions in stress	Stress will be measured before the start of chemotherapy, monthly while receiving chemotherapy (usually 4-5 months) and at 3 months after chemotherapy	7-8 months

External Links

•   Mayo Clinic Clinical Trials