Qigong For PPSP In Breast Cancer Pain In Breast Cancer Survivors

NCT ID: NCT02848989

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-04
• Study Completion Date: 2023-02-03

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Qigong Mind-Body Exercise (QMBE)

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

Group Type: EXPERIMENTAL

Qigong Mind-Body Exercise

Intervention Type: OTHER

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

Interventions

Qigong Mind-Body Exercise

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Jennifer A. Ligibel, MD

Dr., M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer A Ligibel, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

15-347

Identifier Type: -

Identifier Source: org_study_id