Back to resultsQigong For PPSP In Breast Cancer Pain In Breast Cancer Survivors
Primary Purpose
Breast Cancer Surgery Pain, Breast Cancer, Stage 0-III Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Qigong Mind-Body Exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer Surgery Pain focused on measuring Breast Cancer Surgery Pain, Breast Cancer
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
Sites / Locations
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Qigong Mind-Body Exercise (QMBE)
Arm Description
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
Outcomes
Primary Outcome Measures
Rate of completion of QMBE intervention
Complete recruitment of target enrollment of 21 participants within 12 month timeframe.
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.
Secondary Outcome Measures
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.
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
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
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.
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.
Shoulder Strength
Will be assessed using manual muscle testing (MMT).
Range of Motion
Will be assessed using standard goniometric measurement.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02848989
First Posted
June 1, 2016
Last Updated
February 3, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Spaulding Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02848989
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
March 14, 2018 (Actual)
Study Completion Date
February 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Spaulding Rehabilitation Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Surgery Pain, Breast Cancer, Stage 0-III Breast Cancer
Keywords
Breast Cancer Surgery Pain, Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Qigong Mind-Body Exercise (QMBE)
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Qigong Mind-Body Exercise
Intervention Description
An exercise program that involves gentle movements combined with breathing/relaxation techniques
Primary Outcome Measure Information:
Title
Rate of completion of QMBE intervention
Description
Complete recruitment of target enrollment of 21 participants within 12 month timeframe.
Time Frame
12 months
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
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
Secondary Outcome Measure Information:
Title
Changes in Quality of life
Description
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
Title
Degree of Pain
Description
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
Title
Grip Strength
Description
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
Title
Gait & Postural Control
Description
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
Title
Pain Catastrophizing
Description
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
Title
Shoulder Strength
Description
Will be assessed using manual muscle testing (MMT).
Time Frame
3 months
Title
Range of Motion
Description
Will be assessed using standard goniometric measurement.
Time Frame
3 months
Title
Fatigue
Description
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
Title
Self-esteem
Description
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
Title
Anxiety & Depression
Description
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
Title
Stress Levels
Description
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
Title
Mindfulness
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer A Ligibel, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Qigong For PPSP In Breast Cancer Pain In Breast Cancer Survivors
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