- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02848989
Qigong For PPSP In Breast Cancer Pain In Breast Cancer Survivors
Qigong Mind-Body Exercise For Persistent Post-Surgical Pain In Breast Cancer Survivors: A Pilot Study
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Qigong Mind-Body Exercise (QMBE)
After the screening procedures confirm that you are eligible to participate in the research study:
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An exercise program that involves gentle movements combined with breathing/relaxation techniques
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of completion of QMBE intervention
Time Frame: 12 months
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Complete recruitment of target enrollment of 21 participants within 12 month timeframe.
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12 months
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 6 months
|
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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Quality of life
Time Frame: 6 months
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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.
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6 months
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Degree of Pain
Time Frame: 6 months
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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
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6 months
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Grip Strength
Time Frame: 3 months
|
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
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3 months
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Gait & Postural Control
Time Frame: 3 months
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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.
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3 months
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Pain Catastrophizing
Time Frame: 3 months
|
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.
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3 months
|
Shoulder Strength
Time Frame: 3 months
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Will be assessed using manual muscle testing (MMT).
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3 months
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Range of Motion
Time Frame: 3 months
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Will be assessed using standard goniometric measurement.
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3 months
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Fatigue
Time Frame: 3 months
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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.
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3 months
|
Self-esteem
Time Frame: 3 months
|
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.
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3 months
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Anxiety & Depression
Time Frame: 3 months
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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.
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3 months
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Stress Levels
Time Frame: 3 months
|
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.
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3 months
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Mindfulness
Time Frame: 3 months
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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.
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3 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-347
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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