Assessing the Impact of a 12-week Dance Intervention on Quality of Life, Post-surgical Pain, Fatigue, and Body Image in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in the Functional Assessment of Cancer Therapy Breast Symptom Index (FACT-B+4) Total Score from Baseline to 12 Weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Dance Program
30 enrolled participants will complete the following:
- Baseline in-person or virtual visit with surveys.
- 12 weekly virtual dance classes.
- Follow up in-person or virtual visit with post-intervention surveys.
干预措施: Dance Program (Behavioral)
结局指标
主要结局
Change in the Functional Assessment of Cancer Therapy Breast Symptom Index (FACT-B+4) Total Score from Baseline to 12 Weeks
时间窗: 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.
次要结局
- Change in the Brief Pain Inventory Short Form (BPI SF) Score from Baseline to 12 Weeks(Baseline and 12 weeks)
- Change in the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) Total Score from Baseline to 12 Weeks(Baseline and 12 weeks)
- Change in the Cancer Rehabilitation Evaluation Scale (CARES) Score from Baseline to 12 Weeks(Baseline and 12 weeks)
研究者
Jennifer A. Ligibel, MD
Principal Investigator
Dana-Farber Cancer Institute