<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04402593</url>
  </required_header>
  <id_info>
    <org_study_id>CTO-IUSCC-0673</org_study_id>
    <nct_id>NCT04402593</nct_id>
  </id_info>
  <brief_title>Music Therapy For The Treatment Of Cisplatin Induced Tinnitus In Patients With rGCC: A Pilot Study</brief_title>
  <official_title>Music Therapy For The Treatment Of Cisplatin Induced Tinnitus In Patients With Relapsed Germ Cell Cancer (rGCC): A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pilot study evaluating the feasibility of recruitment, retention, and compliance to a&#xD;
      modified Heidelberg Model of Neuro-Music Therapy (mHNMT) in patients with Cisplatin-induced&#xD;
      Tinnitus and relapsed Germ Cell Cancer (rGCC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, interventional pilot study that plans to enroll 15 patients who are&#xD;
      receiving salvage high dose chemo and bone marrow transplant for relapsed Germ cell Cancer&#xD;
      (rGCC). Patients will be asked to go through a series of surveys and screening procedures to&#xD;
      determine eligibility. Once enrolled, patients will receive music therapy while they are&#xD;
      being treated either inpatient or outpatient for their standard of care treatments.&#xD;
&#xD;
      Primary Objective To evaluate the feasibility of recruitment, retention, and compliance to a&#xD;
      mHNMT in patients with CIT and rGCC admitted to BMT service to undergo salvage high-dose&#xD;
      chemotherapy with tandem bone marrow rescue.&#xD;
&#xD;
      Secondary Objectives To estimate the effects of mHNMT on severity of CIT, associated&#xD;
      distress, anxiety, depression, fatigue, benefit findings, sleep, and audiometry measures and&#xD;
      assess number of times homework completed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Due to staffing changes and no potential subjects at this time.&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 2023</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Study will enroll 15 subjects to a twice a week Music Therapy intervention (modified Heidelberg Model of Neuro-Music Therapy) for 3 weeks (6 sessions total).</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment feasibility</measure>
    <time_frame>30 days</time_frame>
    <description>The ability to enroll at least 50% of approached subjects.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention feasibility</measure>
    <time_frame>from the start of intervention until last subject completes intervention (i.e. up to 2 years)</time_frame>
    <description>The ability to successfully retain 60% of enrolled subjects.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compliance and fidelity feasibility</measure>
    <time_frame>from the start of intervention until last subject completes intervention (i.e. up to 2 years)</time_frame>
    <description>The ability to deliver over 90% of planned intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effects of intervention on severity of Cisplatin Induced Tinnitus determined by scores on the Tinnitus Functional Index</measure>
    <time_frame>Baseline, day +50, day +100, and day +270</time_frame>
    <description>The Tinnitus Functional Index (TFI) has eight subscales that address the intrusiveness of tinnitus, the sense of control the patient has, cognitive interference, sleep disturbance, auditory issues, relaxation issues, quality of life, and emotional distress. Minimum value is 1 and maximum value is 10. A higher score indicates worse tinnitus.&#xD;
A mean score of 25 or less than 25 indicates relatively mild tinnitus and little or need for intervention. A mean score ranging from 25-50 indicates significant problems with tinnitus and a possible need for intervention. A mean score of 50 or greater indicates tinnitus severe enough to qualify for more aggressive intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of intervention on associated distress determined by scores on the Tinnitus Questionnaire</measure>
    <time_frame>Baseline, day +50, day +100, and day +270</time_frame>
    <description>For each item, individuals indicate the level of agreement by answering; not true (score 0), partly true (score 1), or true (score 2). A three point scale limits its utility as an outcome measure. Total scores range from 0-82, with higher scores indicating more distressing tinnitus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of intervention on anxiety determined by scores on the Impact of Events Scale</measure>
    <time_frame>Baseline, day +50, day +100, and day +270</time_frame>
    <description>A 22-item self-report measure that assesses subjective distress caused by traumatic events on a scale from 0-4, where 0 is not at all, and 4 is extremely. A higher score indicates increased anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of intervention on depression determined by scores on Hospital Anxiety and Depression Scale</measure>
    <time_frame>Baseline, day +50, day +100, and day +270</time_frame>
    <description>Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of intervention on benefit findings determined by scores on The Benefit Finding Scale</measure>
    <time_frame>Baseline, day +50, day +100, and day +270</time_frame>
    <description>Uses a 5-point Likert scoring method from 1 = Not at all to 5 = Extremely.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Adult Short Form</measure>
    <time_frame>Baseline, day +50, day +100, and day +270</time_frame>
    <description>Use a 5-point Likert scale and employ 7-day recall. Higher scores indicate higher levels of fatigue. Scores are standardized (M = 50, SD = 10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hours asleep</measure>
    <time_frame>Up to 3 weeks</time_frame>
    <description>Actiwatch Spectrum Pro watch. Sleep parameters will be computed using Actiware® software. The sleep parameters produced include total sleep time, sleep latency (minutes until sleep onset), sleep efficiency, frequency and duration of awakenings after sleep onset (WASO), and number of awakenings. These Sleep variables will be scored for each 24-hour period, and averages over the course of use will be computed for nighttime sleep alone and nighttime sleep plus daytime naps to be combined into epochs for assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of times homework completed</measure>
    <time_frame>Each day of intervention until study completion, about 3 weeks</time_frame>
    <description>This will be assessed each day of the intervention and captured using the Actiwatch Spectrum Pro and summed over the entire intervention period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Audiometric evaluation</measure>
    <time_frame>Baseline and day +270 (+/- 90 days)</time_frame>
    <description>The Pure-tone hearing threshold audiometry (PTA) measures and classifies hearing loss into three levels: &lt;25 dB (normal hearing); ≥25 dB &lt;40 dB (mild hearing impairment); and ≥40 dB (moderate-to-severe hearing impairment). PTA will be measured in a soundproofing booth using an audiometer (SA 203, Entomed, Sweden), and include frequencies of 500, 1000, 2000, 3000, 4000, and 6000 Hz in both ears in accordance with the American National Standards Institute (ANSI) standard. The hearing threshold will be defined as the mean hearing threshold of the better ear on PTA tests at 500, 1000, 2000, and 4000 Hz. Hearing loss in this study will be defined as follows: &lt;25 dB (normal hearing), ≥25 dB and &lt;40 dB (mild hearing loss), and ≥40 dB (moderate-to-severe hearing loss).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Relapsed Germ Cell Cancer</condition>
  <condition>Cisplatin Induced Tinnitus</condition>
  <arm_group>
    <arm_group_label>Modified Heidelberg Model of Neuro-Music Therapy (mHNMT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The mHNMT for Tinnitus program was modified based on participant feedback of the original HNMT. This study will include 6 sessions, 2 sessions a week including the following interventions: resonance training, music relaxation, Intonation Training and session review/homework.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Modified Heidelberg Model of Neuro-Music Therapy</intervention_name>
    <description>6 sessions, 2 sessions a week including the following interventions: resonance training, music relaxation, Intonation Training and session review/homework.</description>
    <arm_group_label>Modified Heidelberg Model of Neuro-Music Therapy (mHNMT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥ 18 years old at the time of informed consent.&#xD;
&#xD;
          2. English speaking.&#xD;
&#xD;
          3. Ability to provide written informed consent and HIPAA authorization&#xD;
&#xD;
          4. Confirmed diagnosis of CIT via a score on the TFI of 26 or greater.&#xD;
&#xD;
          5. Personal history of rGCC.&#xD;
&#xD;
          6. Previous exposure to cisplatin.&#xD;
&#xD;
          7. Admitted to BMT service to undergo HDC-tBMR for the first time. (Because this is a&#xD;
             feasibility study, a minimum number of MT sessions will not be required).&#xD;
&#xD;
          8. Agrees not to receive music therapy outside of study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe hearing impairment greater than 60 dB HL in the region of the center tinnitus&#xD;
             frequency&#xD;
&#xD;
          2. Patient's tinnitus can not be pitch matched.&#xD;
&#xD;
          3. Clinical diagnosis of severe mental disorder or psychiatric or neurological disease&#xD;
             such as psychosis, epilepsy, Parkinson's disease, dementia, alcohol or drug abuse.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Debra Burns, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana University Melvin &amp; Bren Simon Cancer Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>June 20, 2023</last_update_submitted>
  <last_update_submitted_qc>June 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Debra S. Burns</investigator_full_name>
    <investigator_title>Chair of the Department of Music and Arts Technology</investigator_title>
  </responsible_party>
  <keyword>relapsed germ cell cancer</keyword>
  <keyword>cisplatin induced tinnitus</keyword>
  <keyword>music therapy</keyword>
  <keyword>germ cell cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms, Germ Cell and Embryonal</mesh_term>
    <mesh_term>Tinnitus</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04402593
org study id: CTO-IUSCC-0673
nct id: NCT04402593
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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).
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Study will enroll 15 subjects to a twice a week Music Therapy intervention (modified Heidelberg Model of Neuro-Music Therapy) for 3 weeks (6 sessions total).
primary purpose: Supportive Care
masking: None (Open Label)
measure: Recruitment feasibility
time frame: 30 days
description: The ability to enroll at least 50% of approached subjects.
measure: Retention feasibility
time frame: from the start of intervention until last subject completes intervention (i.e. up to 2 years)
description: The ability to successfully retain 60% of enrolled subjects.
measure: Compliance and fidelity feasibility
time frame: from the start of intervention until last subject completes intervention (i.e. up to 2 years)
description: The ability to deliver over 90% of planned intervention.
measure: Effects of intervention on severity of Cisplatin Induced Tinnitus determined by scores on the Tinnitus Functional Index
time frame: Baseline, day +50, day +100, and day +270
description: The Tinnitus Functional Index (TFI) has eight subscales that address the intrusiveness of tinnitus, the sense of control the patient has, cognitive interference, sleep disturbance, auditory issues, relaxation issues, quality of life, and emotional distress. Minimum value is 1 and maximum value is 10. A higher score indicates worse tinnitus.
A mean score of 25 or less than 25 indicates relatively mild tinnitus and little or need for intervention. A mean score ranging from 25-50 indicates significant problems with tinnitus and a possible need for intervention. A mean score of 50 or greater indicates tinnitus severe enough to qualify for more aggressive intervention.
measure: Effects of intervention on associated distress determined by scores on the Tinnitus Questionnaire
time frame: Baseline, day +50, day +100, and day +270
description: For each item, individuals indicate the level of agreement by answering; not true (score 0), partly true (score 1), or true (score 2). A three point scale limits its utility as an outcome measure. Total scores range from 0-82, with higher scores indicating more distressing tinnitus.
measure: Effects of intervention on anxiety determined by scores on the Impact of Events Scale
time frame: Baseline, day +50, day +100, and day +270
description: A 22-item self-report measure that assesses subjective distress caused by traumatic events on a scale from 0-4, where 0 is not at all, and 4 is extremely. A higher score indicates increased anxiety.
measure: Effects of intervention on depression determined by scores on Hospital Anxiety and Depression Scale
time frame: Baseline, day +50, day +100, and day +270
description: Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal.
measure: Effects of intervention on benefit findings determined by scores on The Benefit Finding Scale
time frame: Baseline, day +50, day +100, and day +270
description: Uses a 5-point Likert scoring method from 1 = Not at all to 5 = Extremely.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Adult Short Form
time frame: Baseline, day +50, day +100, and day +270
description: Use a 5-point Likert scale and employ 7-day recall. Higher scores indicate higher levels of fatigue. Scores are standardized (M = 50, SD = 10)
measure: Number of hours asleep
time frame: Up to 3 weeks
description: Actiwatch Spectrum Pro watch. Sleep parameters will be computed using Actiware® software. The sleep parameters produced include total sleep time, sleep latency (minutes until sleep onset), sleep efficiency, frequency and duration of awakenings after sleep onset (WASO), and number of awakenings. These Sleep variables will be scored for each 24-hour period, and averages over the course of use will be computed for nighttime sleep alone and nighttime sleep plus daytime naps to be combined into epochs for assessment.
measure: Number of times homework completed
time frame: Each day of intervention until study completion, about 3 weeks
description: This will be assessed each day of the intervention and captured using the Actiwatch Spectrum Pro and summed over the entire intervention period.
measure: Audiometric evaluation
time frame: Baseline and day +270 (+/- 90 days)
description: The Pure-tone hearing threshold audiometry (PTA) measures and classifies hearing loss into three levels: <25 dB (normal hearing); ≥25 dB <40 dB (mild hearing impairment); and ≥40 dB (moderate-to-severe hearing impairment). PTA will be measured in a soundproofing booth using an audiometer (SA 203, Entomed, Sweden), and include frequencies of 500, 1000, 2000, 3000, 4000, and 6000 Hz in both ears in accordance with the American National Standards Institute (ANSI) standard. The hearing threshold will be defined as the mean hearing threshold of the better ear on PTA tests at 500, 1000, 2000, and 4000 Hz. Hearing loss in this study will be defined as follows: <25 dB (normal hearing), ≥25 dB and <40 dB (mild hearing loss), and ≥40 dB (moderate-to-severe hearing loss).
arm group label: Modified Heidelberg Model of Neuro-Music Therapy (mHNMT)
arm group type: Experimental
description: The mHNMT for Tinnitus program was modified based on participant feedback of the original HNMT. This study will include 6 sessions, 2 sessions a week including the following interventions: resonance training, music relaxation, Intonation Training and session review/homework.
intervention type: Behavioral
intervention name: Modified Heidelberg Model of Neuro-Music Therapy
description: 6 sessions, 2 sessions a week including the following interventions: resonance training, music relaxation, Intonation Training and session review/homework.
arm group label: Modified Heidelberg Model of Neuro-Music Therapy (mHNMT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Debra Burns, PhD
role: Principal Investigator
affiliation: Indiana University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Debra S. Burns
investigator title: Chair of the Department of Music and Arts Technology
mesh term: Neoplasms, Germ Cell and Embryonal
mesh term: Tinnitus