Dance Study for Post-surgical Pain in Breast Cancer Survivors

NCT ID: NCT06758102

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-22
• Study Completion Date: 2026-05-01

Brief Summary

The purpose of this study is to examine how a 12-week, virtual dance program may improve pain and quality of life in participants with persistent post-surgical pain, or PPSP, following mastectomy or lumpectomy.

Detailed Description

This is a single-arm, Phase 1 study is to assess how a 12-week, virtual dance program may improve persistent post-surgical pain (PPSP) and other participant-reported outcomes of quality of life, fatigue, and body image for breast cancer survivors following mastectomy or lumpectomy.

The study procedures including screening for eligibility and surveys.

Participation in this research study is expected to last up to 16 weeks.

It is expected that about 30 people will take part in this research study.

Conditions

Breast Cancer; Survivorship; Pain, Postoperative

Study Design

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

Study Groups

Dance Program

30 enrolled participants will complete the following:

• Baseline in-person or virtual visit with surveys.
• 12 weekly virtual dance classes.
• Follow up in-person or virtual visit with post-intervention surveys.

Group Type: EXPERIMENTAL

Dance Program

Intervention Type: BEHAVIORAL

A 12-week, virtual dance program consisting of seated and standing choreography and contemporary style elements will be taught by a certified dance instructor. Sessions will be conducted by the HIPAA-compliant, video-conferencing platform, Zoom.

Interventions

Dance Program

A 12-week, virtual dance program consisting of seated and standing choreography and contemporary style elements will be taught by a certified dance instructor. Sessions will be conducted by the HIPAA-compliant, video-conferencing platform, Zoom.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• History of Stage 0-III invasive breast cancer
• Having undergone lumpectomy or mastectomy
• Moderate to severe persistent post-surgical pain, as defined by pain scores ≥3 on a numerical rating scale (NRS) of 0-10 (10 being the most severe pain) at least 3 months after completion of surgery, chemotherapy, and/or radiation
• Pain scores of 3-4 are categorized as moderate pain; scores of 5-10 are categorized as severe pain26
• Age ≥ 18 years
• Able to read and understand English (to complete required questionnaires and participate in classes)
• Ability to provide informed consent
• Ability to perform seated exercises

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, untreated substance use disorder, severe personality disorder)
• Metastatic breast or other concurrent cancer
• Pregnant
• Recent history of attending regular dance or similar classes (e.g. yoga or tai chi classes i.e. 20 or more classes in the past 6 months)
• Planned surgery anticipated during the intervention period
• History of a chronic medical condition that has the potential to significantly impact upper extremity function (e.g. stroke, Parkinson's disease, Multiple Sclerosis)
• Currently enrolled in a physical therapy course
• Presence of medical conditions or medications that would prohibit participation in an exercise program

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Jennifer A. Ligibel, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Ligibel, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jennifer Ligibel, MD

Role: CONTACT

jennifer_ligibel@dfci.harvard.edu

617-632-3800

Facility Contacts

Jennifer Ligibel, MD

Role: primary

Jennifer_Ligibel@dfci.harvard.edu

617-632-3800

Other Identifiers

24-586

Identifier Type: -

Identifier Source: org_study_id