An interventional study of Qigong Mind-Body Exercise in Breast Cancer Surgery Pain, Breast Cancer and Stage 0-III Breast Cancer, sponsored by Dana-Farber Cancer Institute. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Supportive care
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.
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.
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This study's enrollment of 21 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
After the screening procedures confirm that you are eligible to participate in the research study: * Breast cancer survivors with persistent post-surgical pain (PPSP) into a 12-week program of Qigong mind-body exercise (QMBE). * Outcome assessments related to pain, function, and quality of life
Other: Qigong Mind-Body Exercise
An exercise program that involves gentle movements combined with breathing/relaxation techniques
Rate of completion of QMBE intervention
Complete recruitment of target enrollment of 21 participants within 12 month timeframe.
Time frame: 12 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Total number of adverse events sustained from participation in QMBE will be collected for each participant through home practice logs for at home QMBE participation and instructors will report any adverse events that occur during QMBE class on attendance logs. Any adverse events observed will be evaluated according to the DFCI/Harvard Cancer Center guidelines. The study will be considered safe if zero adverse events are observed/reported from participation in prescribed QMBE classes and/or at home practice.
Time frame: 6 months
Changes in Quality of life
QOL will be assessed using the Functional Assessment of Cancer Therapy Breast Symptom Index (FACT-B+4). This instrument consists of 42 items that measure physical, emotional, social and functional well-being, as well as breast cancer specific symptomology associated with upper extremity dysfunction.
Time frame: 6 months
Degree of Pain
Degree of pain will be measured by the Brief Pain Inventory Short Form (BPI SF) and a Pain Medication Log.21 The BPI SF consists of 9 items that measure the severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. Reliability coefficients for the BPI Severity and Interference scales ranged from .82 to .95
Time frame: 6 months
Grip Strength
Grip strength of both hands will be assessed using the Jamar® Hand Dynamometer. Measurement will be recorded to the nearest 0.5 kg, and repeated an average of three times
Time frame: 3 months
Gait & Postural Control
Gait \& postural control will be kinematically assessed during standing and walking using an 8-camera motion analysis system (Vicon 512, Oxford, UK) using standard protocols employed in prior mind-body studies as well as clinical evaluations for both children and adults with walking abnormalities due to mobility-limiting conditions, at the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital.
Time frame: 3 months
Pain Catastrophizing
Pain catastrophizing scale will be used to assess catastrophic thinking associated with pain. This instrument consists of 13 items that measure rumination, magnification, and helplessness related to pain.
Time frame: 3 months
Shoulder Strength
Will be assessed using manual muscle testing (MMT).
Time frame: 3 months
Range of Motion
Will be assessed using standard goniometric measurement.
Time frame: 3 months
Fatigue
Fatigue will be assessed by the 13 item FACIT-F fatigue subscale. This validated instrument measures the intensity of fatigue experienced during the 7 days before questionnaire administration.
Time frame: 3 months
Self-esteem
Self-esteem will be measured by the 10 item Rosenberg Self-Esteem Scale. This validated instrument measures global self-worth by measuring both positive and negative feelings about the self.
Time frame: 3 months
Anxiety & Depression
Anxiety and depression will be measured by the Hospital and Anxiety and Depression Scale (HADS). This validated instrument consists of 14 items that measure current feelings of anxiety and depression.
Time frame: 3 months
Stress Levels
Stress levels will be measured by the 10 item Perceived Stress Scale (PSS). This validated instrument measures the degree to which situations in one's life are appraised as stressful.
Time frame: 3 months
Mindfulness
Mindfulness will be assessed using the Multidimensional Assessment of Interoceptive Awareness Scale (MAIA). This 32-item instrument measures a patient's bodily and emotional awareness and ability to self-regulate these factors.
Time frame: 3 months
Plan to share: No
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Dana-Farber Cancer Institute