Dance Study for Post-surgical Pain in Breast Cancer Survivors

NCT06758102 | Recruiting

• 1 other identifier: 24-586
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Survivorship; Pain, Postoperative

Keywords

Breast Cancer Survivorship; Breast Cancer Survivor; Survivorship; Pain, Postoperative; PPSP; Persistent Post-Surgical Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in the Brief Pain Inventory Short Form (BPI SF) Score from Baseline to 12 Weeks

  Baseline and 12 weeks

• Change in the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) Total Score from Baseline to 12 Weeks

  Baseline and 12 weeks

• Change in the Cancer Rehabilitation Evaluation Scale (CARES) Score from Baseline to 12 Weeks

  Baseline and 12 weeks

Study Arms (1)

Dance Program

EXPERIMENTAL

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

Interventions

Dance Program 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.

Dance Program

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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, 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jennifer Ligibel, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Ligibel, MD

CONTACT

617-632-3800; jennifer_ligibel@dfci.harvard.edu

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: Principal Investigator

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 3, 2025
• Study Start: January 22, 2025
• Primary Completion: February 28, 2026
• Study Completion: May 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)