Music Therapy For The Treatment Of Cisplatin Induced Tinnitus In Patients With Relapsed Germ Cell Cancer (rGCC): A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Recruitment feasibility
研究概览
简要总结
Pilot study evaluating the feasibility of recruitment, retention, and compliance to a modified Heidelberg Model of Neuro-Music Therapy (mHNMT) in patients with Cisplatin-induced Tinnitus and relapsed Germ Cell Cancer (rGCC).
详细描述
This is a prospective, interventional pilot study that plans to enroll 15 patients who are receiving salvage high dose chemo and bone marrow transplant for relapsed Germ cell Cancer (rGCC). Patients will be asked to go through a series of surveys and screening procedures to determine eligibility. Once enrolled, patients will receive music therapy while they are being treated either inpatient or outpatient for their standard of care treatments.
Primary Objective To evaluate the feasibility of recruitment, retention, and compliance to a mHNMT in patients with CIT and rGCC admitted to BMT service to undergo salvage high-dose chemotherapy with tandem bone marrow rescue.
Secondary Objectives To estimate the effects of mHNMT on severity of CIT, associated distress, anxiety, depression, fatigue, benefit findings, sleep, and audiometry measures and assess number of times homework completed.
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
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old at the time of informed consent.
- •English speaking.
- •Ability to provide written informed consent and HIPAA authorization
- •Confirmed diagnosis of CIT via a score on the TFI of 26 or greater.
- •Personal history of rGCC.
- •Previous exposure to cisplatin.
- •Admitted to BMT service to undergo HDC-tBMR for the first time. (Because this is a feasibility study, a minimum number of MT sessions will not be required).
- •Agrees not to receive music therapy outside of study.
排除标准
- •Severe hearing impairment greater than 60 dB HL in the region of the center tinnitus frequency
- •Patient's tinnitus can not be pitch matched.
- •Clinical diagnosis of severe mental disorder or psychiatric or neurological disease such as psychosis, epilepsy, Parkinson's disease, dementia, alcohol or drug abuse.
结局指标
主要结局
Recruitment feasibility
时间窗: 30 days
The ability to enroll at least 50% of approached subjects.
Retention feasibility
时间窗: from the start of intervention until last subject completes intervention (i.e. up to 2 years)
The ability to successfully retain 60% of enrolled subjects.
Compliance and fidelity feasibility
时间窗: from the start of intervention until last subject completes intervention (i.e. up to 2 years)
The ability to deliver over 90% of planned intervention.
次要结局
- Effects of intervention on severity of Cisplatin Induced Tinnitus determined by scores on the Tinnitus Functional Index(Baseline, day +50, day +100, and day +270)
- Effects of intervention on benefit findings determined by scores on The Benefit Finding Scale(Baseline, day +50, day +100, and day +270)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Adult Short Form(Baseline, day +50, day +100, and day +270)
- Number of hours asleep(Up to 3 weeks)
- Effects of intervention on depression determined by scores on Hospital Anxiety and Depression Scale(Baseline, day +50, day +100, and day +270)
- Number of times homework completed(Each day of intervention until study completion, about 3 weeks)
- Effects of intervention on associated distress determined by scores on the Tinnitus Questionnaire(Baseline, day +50, day +100, and day +270)
- Effects of intervention on anxiety determined by scores on the Impact of Events Scale(Baseline, day +50, day +100, and day +270)
- Audiometric evaluation(Baseline and day +270 (+/- 90 days))
研究者
Debra S. Burns
Chair of the Department of Music and Arts Technology
Indiana University