A Randomized Controlled Trial to Assess the Benefit of Art & Music Therapy on Quality of Life in Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Functional Assessment of Cancer Therapy: Breast Cancer (FACT-B) questionnaire scores
研究概览
简要总结
This is a study of art-based and music-based therapy programs lasting three months (with additional follow-up 3 months after the end of the trial) in breast cancer patients currently receiving therapy as well as in cancer survivors.
详细描述
A cancer diagnosis is often associated with adverse psychosocial effects, including: increased stress and anxiety, fatigue and sleep disturbance, impaired memory and cognition, and poor quality of life. Chemotherapy can cause a cognitive decline in up to 75% of patients; an impairment that oftentimes persists beyond completion of the regimen. This is known as "chemobrain". Integrative therapies are actively being investigated to help improve psychological wellbeing among cancer patients and survivors.
The current standard at this institution is to inform patients of different complementary services that are available, including art therapy, music therapy or acupuncture, but not require patients to use them.
Participants in this study will be randomized to one of three arms 1) Art therapy program, 2) Music therapy program, or 3) Standard of care (SOC). In-person and at-home therapy sessions will be scheduled in alternating, weekly sessions, to allow one week of self-reflection and remote therapy between in-person sessions. Each participant will be asked to attend two in-person therapy sessions per month (total of 6).
The primary objective of this study is to determine the efficacy of a 3-month, therapist-led art or music therapy program to improve quality of life in breast cancer patients currently receiving therapy and in cancer survivors.
Secondary objectives of this study are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Breast cancer diagnosis (stage 0-III)
- •Treated at Cleveland Clinic by medical oncologist, radiation oncologist, and/or breast surgeon Patients currently undergoing treatment or have completed active treatment (surgery, radiation or chemotherapy) within past 5 years.
- •Able and willing to participate in art or music therapy programs at Maroone Cancer Center
- •Subjects must have the ability to understand and the willingness to sign a written informed consent document
- •Ability to read and write in English
- •Performance status 0 or 1 as per ECOG scale
排除标准
- •No prior history of breast cancer
- •History of metastatic disease (Stage IV)
- •Not being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Cleveland Clinic
- •Unable or unwilling to participate in art or music therapy program at Maroone Cancer Center
结局指标
主要结局
Functional Assessment of Cancer Therapy: Breast Cancer (FACT-B) questionnaire scores
时间窗: Baseline
Quality of life (QOL) as measured by Functional Assessment of Cancer Therapy: Breast Cancer (FACT-B) questionnaire. This is a validated survey, completed by the patient, consisting of 37 items, each scored on a 0-4, Likert scale (0 = "Not at all"; 4= "Very much"). Subscales include: Physical Well-Being (PWB) (score range: 0-28), Social/Family Well-Being (SWB) (score range: 0-28), Emotional Well-Being (EWB) (score range: 0-24), Functional Well-being (FWB) (score range: 0-28), and the additional breast cancer concerns (BCS) (score range: 0-40) all with higher scores indicating better outcomes. Total scale scores range from 0 to 148 with higher scores indicating better outcomes.
FACT-B questionnaire scores
时间窗: At 180-days
QOL as measured by FACT-B questionnaire scores. This is a validated survey, completed by the patient, consisting of 37 questions, each scored on a 0-4, Likert scale (0 = "Not at all"; 4= "Very much"). Subscales include: PWB (score range: 0-28), SWB (score range: 0-28), EWB (score range: 0-24), FWB (score range: 0-28), and BCS (score range: 0-40) all with higher scores indicating better outcomes. Total scale scores range from 0 to 148 with higher scores indicating better outcomes.
次要结局
- Generalized Anxiety Disorder-7 item (GAD-7) scores(At 180-days)
- FACT-Cog questionnaire scores(At 180-days)
- Patient Health Questionnaire-9 item (PHQ-9) scores(At 180-days)
- Functional Assessment of Cancer Therapy - Cognition (FACT-Cog) questionnaire scores(Baseline)
- Attitudes towards art/music scores(At 180-days)