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Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy

Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02067351
Enrollment
6
Registered
2014-02-20
Start date
2014-04-30
Completion date
2017-01-31
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

BEHAVIORALMindfulness

Meditation, body scan, yoga.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Pregnant * Practicing mindfulness

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frameDescription
Stress - measured by the Perceived Stress Scale - statistically and clinically significant reductions in stress7-8 monthsStress will be measured before the start of chemotherapy, monthly while receiving chemotherapy (usually 4-5 months) and at 3 months after chemotherapy

Other

MeasureTime frameDescription
Fatigue - Multidimensional Fatigue Symptom Inventory -Short Form statistically and clinically significant reductions in fatigue score7-8 monthsFatigue 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 life7-8 monthsQuality 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 sleep7-8 monthsSleep will be measured before the start of chemotherapy, monthly while receiving chemotherapy (usually 4-5 months) and at 3 months after chemotherapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026