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Breast Cancer Surgery PainNCT02848989

Qigong For PPSP In Breast Cancer Pain In Breast Cancer Survivors

A study testing Qigong Mind-Body Exercise in people with Breast Cancer Surgery Pain and Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Qigong Mind-Body Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
4 Apr 2017to 3 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Qigong Mind-Body Exercise
Keywords
Breast Cancer Surgery Pain, Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Qigong Mind-Body ExerciseOther

    An exercise program that involves gentle movements combined with breathing/relaxation techniques

Study groups in NCT02848989
Study groupRoleWhat they receive
Qigong Mind-Body Exercise (QMBE)ExperimentalAfter 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
Receives: Other: Qigong Mind-Body Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of completion of QMBE intervention

    Complete recruitment of target enrollment of 21 participants within 12 month timeframe.

    Measured: 12 months

  2. 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.

    Measured: 6 months

Secondary outcomes (12)

  1. 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.

    Measured: 6 months

  2. 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

    Measured: 6 months

  3. 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

    Measured: 3 months

  4. 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.

    Measured: 3 months

  5. 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.

    Measured: 3 months

  6. Shoulder Strength

    Will be assessed using manual muscle testing (MMT).

    Measured: 3 months

  7. Range of Motion

    Will be assessed using standard goniometric measurement.

    Measured: 3 months

  8. 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.

    Measured: 3 months

  9. 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.

    Measured: 3 months

  10. 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.

    Measured: 3 months

  11. 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.

    Measured: 3 months

  12. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2016 (estimated)
  2. Study start4 Apr 2017
  3. Primary completion14 Mar 2018
  4. Study completion3 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02848989
Sponsor's protocol ID
15-347
Status last verified
Feb 2023
First submitted
1 Jun 2016
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Qigong Mind-Body Exercise in people with Breast Cancer Surgery Pain and Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of completion of QMBE intervention (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02848989.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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