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RecruitingInterventional

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

NCT ID: NCT06758102Sponsor: Dana-Farber Cancer InstituteLast updated: 2026-04-08

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.

Arms & interventions

  • BehavioralDance 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.

Outcome measures

Primary

  • 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.

    Time frame: Baseline and 12 weeks

Secondary

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

    Time frame: Baseline and 12 weeks

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

    Time frame: Baseline and 12 weeks

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

    Time frame: Baseline and 12 weeks

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: Yes
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 locations (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Jennifer Ligibel, MD · Contact
Jennifer Ligibel, MD · Principal Investigator
Dance Study for Post-surgical Pain in Breast Cancer Survivors | Cancerify