Clinical trial NCT02848989: Qigong For PPSP In Breast Cancer Pain In Breast Cancer Survivors
Official title: Qigong Mind-Body Exercise For Persistent Post-Surgical Pain In Breast Cancer Survivors: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Surgery Pain
Breast Cancer
Stage 0-III Breast Cancer
Keywords: Breast Cancer Surgery Pain
Breast Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Spaulding Rehabilitation Hospital
First posted: 2016-07-29
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Studies have shown that on-going pain following breast surgery is common and may limit the ability to participate in physical activity, cause tiredness, difficulty in daily chores/activities as well as other problems.

This study is evaluating whether participating in a 12-week Qigong program (pronounced chee kung), an exercise program that involves gentle movements combined with breathing/relaxation techniques, also known as mind-body exercise, leads to improvement of pain, physical function, and quality of life among breast cancer survivors that have significant pain following surgery.

Detailed description: This is a pilot/feasibility study designed to look at the potential benefits of a 12-week program of Qigong mind-body exercise program. The study applies to women who have completed physical therapy treatment on symptoms such as pain, and difficulty moving/strength of arm in women who are experiencing on-going symptoms after breast cancer surgery. The results of this study will be used to help design future studies of the effect of Qigong programs in breast cancer survivors.

Eligibility criteria: Inclusion Criteria:

* History of Stage 0-III breast cancer;
* Persistent post-surgical pain at least 3 months after completion of surgery, chemotherapy, and/or radiation;
* Completion of a course of physical therapy

Exclusion Criteria:

* Unstable cardiovascular disease in the last 6 months
* Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder);
* Metastatic breast or other cancer;
* Participation in more than 240 minutes of moderate-intensity exercise per week (as determined by Leisure Score Index questionnaire)
* Pregnant or breastfeeding
* Recent history of attending regular QMBE or similar classes (e.g. yoga or tai chi classes), (i.e.20 or more classes in the past 6 months).
* Currently enrolled in a physical therapy course

Primary outcomes:
measure: Rate of completion of QMBE intervention
timeFrame: 12 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 6 months
Secondary outcomes:
measure: Changes in Quality of life
timeFrame: 6 months
measure: Degree of Pain
timeFrame: 6 months
measure: Grip Strength
timeFrame: 3 months
measure: Gait & Postural Control
timeFrame: 3 months
measure: Pain Catastrophizing
timeFrame: 3 months
measure: Shoulder Strength
timeFrame: 3 months
measure: Range of Motion
timeFrame: 3 months
measure: Fatigue
timeFrame: 3 months
measure: Self-esteem
timeFrame: 3 months
measure: Anxiety & Depression
timeFrame: 3 months
measure: Stress Levels
timeFrame: 3 months
measure: Mindfulness
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Jennifer A Ligibel, MD
role: PRINCIPAL_INVESTIGATOR
References: