Dance Study for Post-surgical Pain in Breast Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDana-Farber Cancer Institute
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Dance Program
BehavioralA 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Dance ProgramExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline and 12 weeksSecondary outcomes
1
Change in the Brief Pain Inventory Short Form (BPI SF) Score from Baseline to 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.
Time frame
Baseline and 12 weeks2
Change in the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) Total Score from Baseline to 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.
Time frame
Baseline and 12 weeks3
Change in the Cancer Rehabilitation Evaluation Scale (CARES) Score from Baseline to 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.
Time frame
Baseline and 12 weeksSponsors and contacts
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Source ClinicalTrials.gov