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Active, Not Recruiting

NCT Number: NCT06758102

Dance Study for Post-surgical Pain 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in the Functional Assessment of Cancer Therapy Breast Symptom Index (FACT-B+4) Total Score from Baseline to 12 Weeks

    Time frame: Baseline and 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.

Secondary outcomes

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

    Time frame: Baseline and 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.

  2. 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

    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.

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

    Time frame: Baseline and 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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 3, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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