Clinical trial NCT06758102: Dance Study for Post-surgical Pain in Breast Cancer Survivors
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Survivorship
Pain, Postoperative
Keywords: Breast Cancer Survivorship
Breast Cancer Survivor
Survivorship
Pain, Postoperative
PPSP
Persistent Post-Surgical Pain
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Functional Assessment of Cancer Therapy Breast Symptom Index (FACT-B+4) Total Score from Baseline to 12 Weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in the Brief Pain Inventory Short Form (BPI SF) Score from Baseline to 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change in the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) Total Score from Baseline to 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change in the Cancer Rehabilitation Evaluation Scale (CARES) Score from Baseline to 12 Weeks
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Jennifer Ligibel, MD
role: PRINCIPAL_INVESTIGATOR
References: