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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dance Program | Experimental | 30 enrolled participants will complete the following:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Ligibel, MD | Contact | 617-632-3800 | jennifer_ligibel@dfci.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Ligibel, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Baseline and 12 weeks |
| 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. | Baseline and 12 weeks |
| 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. | Baseline and 12 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |