Dance Study for Post-surgical Pain in Breast Cancer Survivors

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Breast Cancer; Survivorship; Pain, Postoperative

Treatments: Behavioral: Dance Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06758102

24-586

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Dance Program

Experimental group

Description:

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.

Treatment:

Behavioral: Dance Program