Relapsed Germ Cell CancerNCT04402593
Music Therapy For The Treatment Of Cisplatin Induced Tinnitus In Patients With rGCC: A Pilot Study
A study testing Modified Heidelberg Model of Neuro-Music Therapy in people with Relapsed Germ Cell Cancer and Cisplatin Induced Tinnitus, run by Indiana University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Germ Cell Cancer, Cisplatin Induced Tinnitus
- What is being tested?
- Modified Heidelberg Model of Neuro-Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: Music Therapy For The Treatment Of Cisplatin Induced Tinnitus In Patients With Relapsed Germ Cell Cancer (rGCC): A Pilot Study
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).
Read the 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.
- Being tested
- Modified Heidelberg Model of Neuro-Music Therapy
- Keywords
- relapsed germ cell cancer, cisplatin induced tinnitus, music therapy, germ cell cancer
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Heidelberg Model of Neuro-Music TherapyBehavioural
6 sessions, 2 sessions a week including the following interventions: resonance training, music relaxation, Intonation Training and session review/homework.
| Study group | Role | What they receive |
|---|---|---|
| Modified Heidelberg Model of Neuro-Music Therapy (mHNMT) | Experimental | 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. Receives: Behavioral: Modified Heidelberg Model of Neuro-Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility
The ability to enroll at least 50% of approached subjects.
Measured: 30 days
Retention feasibility
The ability to successfully retain 60% of enrolled subjects.
Measured: from the start of intervention until last subject completes intervention (i.e. up to 2 years)
Compliance and fidelity feasibility
The ability to deliver over 90% of planned intervention.
Measured: from the start of intervention until last subject completes intervention (i.e. up to 2 years)
Secondary outcomes (9)
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.
Measured: Baseline, day +50, day +100, and day +270
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.
Measured: Baseline, day +50, day +100, and day +270
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.
Measured: Baseline, day +50, day +100, and day +270
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.
Measured: Baseline, day +50, day +100, and day +270
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.
Measured: Baseline, day +50, day +100, and day +270
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)
Measured: Baseline, day +50, day +100, and day +270
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.
Measured: Up to 3 weeks
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.
Measured: Each day of intervention until study completion, about 3 weeks
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).
Measured: Baseline and day +270 (+/- 90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study startSep 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: Due to staffing changes and no potential subjects at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Germ Cell CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Debra S. Burns, Indiana University
- Investigators
- Debra Burns, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402593
- Sponsor's protocol ID
- CTO-IUSCC-0673
- Status last verified
- Jun 2023
- First submitted
- 12 May 2020
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy For The Treatment Of Cisplatin Induced Tinnitus In Patients With Relapsed Germ Cell Cancer (rGCC): A Pilot Study
- ClinicalTrials.gov ID
- NCT04402593
- Acronym / sponsor ID
- CTO-IUSCC-0673
- Keywords
- relapsed germ cell cancer, cisplatin induced tinnitus, music therapy, germ cell cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to staffing changes and no potential subjects at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Modified Heidelberg Model of Neuro-Music Therapy (mHNMT) | Experimental | Behavioral: Modified Heidelberg Model of Neuro-Music TherapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Heidelberg Model of Neuro-Music Therapy6 sessions, 2 sessions a week including the following interventions: resonance training, music relaxation, Intonation Training and session review/homework. | Behavioural | Modified Heidelberg Model of Neuro-Music Therapy (mHNMT) |
Primary outcome
Recruitment feasibility
Time frame: 30 days
The ability to enroll at least 50% of approached subjects.
Retention feasibility
Time frame: 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
Time frame: 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.
9 secondary outcomes
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
Effects of intervention on associated distress determined by scores on the Tinnitus Questionnaire
Time frame: Baseline, day +50, day +100, and day +270
Effects of intervention on anxiety determined by scores on the Impact of Events Scale
Time frame: Baseline, day +50, day +100, and day +270
Effects of intervention on depression determined by scores on Hospital Anxiety and Depression Scale
Time frame: Baseline, day +50, day +100, and day +270
Effects of intervention on benefit findings determined by scores on The Benefit Finding Scale
Time frame: Baseline, day +50, day +100, and day +270
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Adult Short Form
Time frame: Baseline, day +50, day +100, and day +270
Number of hours asleep
Time frame: Up to 3 weeks
Number of times homework completed
Time frame: Each day of intervention until study completion, about 3 weeks
Audiometric evaluation
Time frame: Baseline and day +270 (+/- 90 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra Burns, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Heidelberg Model of Neuro-Music Therapy in people with Relapsed Germ Cell Cancer and Cisplatin Induced Tinnitus, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.