Dance Study for Post-surgical Pain in Breast Cancer Survivors

Assessing the Impact of a 12-week Dance Intervention on Quality of Life, Post-surgical Pain, Fatigue, and Body Image in Breast Cancer Survivors

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Breast Cancer; Survivorship
• Intervention / Treatment: Behavioral: Dance Program

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Ligibel, MD; Phone Number: 617-632-3800; Email: Jennifer_Ligibel@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Jennifer Ligibel, MD; Phone Number: 617-632-3800; Email: Jennifer_Ligibel@dfci.harvard.edu
      • Principal Investigator: Jennifer Ligibel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Functional Assessment of Cancer Therapy Breast Symptom Index (FACT-B+4) Total Score from Baseline to 12 Weeks	Assessed by the Functional Assessment of Cancer Therapy Breast Symptom Index (FACT-B+4), a 42-item measure of physical, emotional, social and functional well-being, as well as breast cancer specific symptomology associated with upper extremity dysfunction during the 7 days prior to questionnaire administration. Items are rated on a 5-point Likert-type scale with answers ranging from 0 "Not at all" to 4 "Very much." A total scores range is 0 to 168 with a higher score indicating better quality of life.	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Brief Pain Inventory Short Form (BPI SF) Score from Baseline to 12 Weeks	Assessed by the Brief Pain Inventory Short Form (BPI SF), a 9-item measure of the severity of pain and pain interference in the 24 hour prior to questionnaire administrations. A simple numeric rating scale from 0 to 10 is used for item rating, and a total score is the mean of the item ratings. Higher scores indicate greater pain intensity and greater interference with function.	Baseline and 12 weeks
Change in the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) Total Score from Baseline to 12 Weeks	Assessed by the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F), a 13-item measure of the intensity of fatigue experienced during the 7 days prior to questionnaire administration. Items are rated on a 5-point Likert-type scale with answers ranging from 0 "Not at all" to 4 "very much" and items 7 and 8 being reversed score. A total scores range is 0 to 52 with a higher score indicating better quality of life.	Baseline and 12 weeks
Change in the Cancer Rehabilitation Evaluation Scale (CARES) Score from Baseline to 12 Weeks	Assessed by the Cancer Rehabilitation Evaluation Scale (CARES), a 6-item measure of body image and self-esteem by measuring negative feelings about the body and self-perception in the month prior to questionnaire administration. Items are rated on a 5-point Likert-type scale with answers ranging from 0 "Not at all" to 4 "Very much." A total scores range is 0 to 24 with a higher score indicating greater negative body image and self-esteem.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Jennifer Ligibel, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2025
• Primary Completion (Actual): February 28, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: December 26, 2024
• First Submitted That Met QC Criteria: December 26, 2024
• First Posted (Actual): January 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Survivorship; Breast Cancer Survivor; Pain, Postoperative; Breast Cancer Survivorship; PPSP; Persistent Post-Surgical Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Pain, Postoperative; Breast Neoplasms
• Other Study ID Numbers: 24-586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No