Qigong For PPSP In Breast Cancer Pain In Breast Cancer Survivors

NCT02848989 | Completed DMC

• 1 other identifier: 15-347
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Surgery Pain; Breast Cancer; Stage 0-III Breast Cancer

Keywords

Breast Cancer Surgery Pain; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Rate of completion of QMBE intervention

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

  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.

  6 months

Secondary Outcomes (12)

• Changes in Quality of life

  6 months

• Degree of Pain

  6 months

• Grip Strength

  3 months

• Gait & Postural Control

  3 months

• Pain Catastrophizing

  3 months

Study Arms (1)

Qigong Mind-Body Exercise (QMBE)

EXPERIMENTAL

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

Interventions

Qigong Mind-Body Exercise OTHER

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

Qigong Mind-Body Exercise (QMBE)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Spaulding Rehabilitation Hospital: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jennifer A Ligibel, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr., M.D.

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: July 29, 2016
• Study Start: April 4, 2017
• Primary Completion: March 14, 2018
• Study Completion: February 3, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)