Music Therapy For The Treatment Of Cisplatin Induced Tinnitus In Patients With rGCC: A Pilot Study

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Primary Purpose

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Modified Heidelberg Model of Neuro-Music Therapy

About this trial

This is an interventional supportive care trial for Relapsed Germ Cell Cancer focused on measuring relapsed germ cell cancer, cisplatin induced tinnitus, music therapy, germ cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

≥ 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.

Exclusion Criteria:

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.

Sites / Locations

Indiana University Melvin & Bren Simon Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Modified Heidelberg Model of Neuro-Music Therapy (mHNMT)

Arm 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.

Outcomes

Primary Outcome Measures

Recruitment feasibility

The ability to enroll at least 50% of approached subjects.

Retention feasibility

The ability to successfully retain 60% of enrolled subjects.

Compliance and fidelity feasibility

The ability to deliver over 90% of planned intervention.

Secondary Outcome Measures

Effects of intervention on severity of Cisplatin Induced Tinnitus determined by scores on the Tinnitus Functional Index

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.

Effects of intervention on associated distress determined by scores on the Tinnitus Questionnaire

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.

Effects of intervention on anxiety determined by scores on the Impact of Events Scale

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.

Effects of intervention on depression determined by scores on Hospital Anxiety and Depression Scale

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.

Effects of intervention on benefit findings determined by scores on The Benefit Finding Scale

Uses a 5-point Likert scoring method from 1 = Not at all to 5 = Extremely.

Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Adult Short Form

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)

Number of hours asleep

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.

Number of times homework completed

This will be assessed each day of the intervention and captured using the Actiwatch Spectrum Pro and summed over the entire intervention period.

Audiometric evaluation

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).

Full Information

NCT ID

NCT04402593

First Posted

May 12, 2020

Last Updated

June 20, 2023

Sponsor

Indiana University

1. Study Identification

Unique Protocol Identification Number

NCT04402593

Brief Title

Music Therapy For The Treatment Of Cisplatin Induced Tinnitus In Patients With rGCC: A Pilot Study

Official Title

Music Therapy For The Treatment Of Cisplatin Induced Tinnitus In Patients With Relapsed Germ Cell Cancer (rGCC): A Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Due to staffing changes and no potential subjects at this time.

Study Start Date

September 2023 (Anticipated)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsed Germ Cell Cancer, Cisplatin Induced Tinnitus

Keywords

relapsed germ cell cancer, cisplatin induced tinnitus, music therapy, germ cell cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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).

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Modified Heidelberg Model of Neuro-Music Therapy (mHNMT)

Arm Type

Experimental

Arm 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(s)

Modified Heidelberg Model of Neuro-Music Therapy

Intervention Description

6 sessions, 2 sessions a week including the following interventions: resonance training, music relaxation, Intonation Training and session review/homework.

Primary Outcome Measure Information:

Title

Recruitment feasibility

Description

The ability to enroll at least 50% of approached subjects.

Time Frame

30 days

Title

Retention feasibility

Description

The ability to successfully retain 60% of enrolled subjects.

Time Frame

from the start of intervention until last subject completes intervention (i.e. up to 2 years)

Title

Compliance and fidelity feasibility

Description

The ability to deliver over 90% of planned intervention.

Time Frame

from the start of intervention until last subject completes intervention (i.e. up to 2 years)

Secondary Outcome Measure Information:

Title

Effects of intervention on severity of Cisplatin Induced Tinnitus determined by scores on the Tinnitus Functional Index

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.

Time Frame