Lung CancerNCT06172959
The Short-term Impact of Vocal Intonation Therapy (VIT) and Therapeutic Singing (TS) on Respiratory Function in Patients With Lung Cancer
A study testing Vocal Intonation Therapy (VIT) and Therapeutic Singing (TS) in people with Lung Cancer, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to examine the short-term impact of Vocal Intonation Therapy (VIT) and Therapeutic Singing (TS) on respiratory function in patients with lung cancer. As a secondary outcome, this research will evaluate the effect of the music intervention on respiratory quality of life. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Vocal Intonation Therapy (VIT) and Therapeutic Singing (TS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2024to 1 Jun 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will include three patients diagnosed with lung cancer, stages I-III, who have undergone a thoracentesis or thoracotomy in the last 12 months. Thoracic surgical procedures include pulmonary lobectomy or cancer-related surgical procedure (e.g., pneumonectomy). This diagnosis must be made by the patient's oncologist and medical team.
- The age range will be 40 to 80 years old. Both female and male participants from any race and ethnicity will be included in the study.
- The study will include English and Spanish speakers only.
- Patients must have less than five years of voice training experience (e.g., choir, private voice lessons).
Who cannot join
- Patients in respiratory failure
- Individuals with severe neurological and hearing impairments.
- Patients with diagnosed dysphonia and individuals who have undergone a laryngectomy
- Participants that do not have access to an electronic device, either an iPad, tablet, or laptop, as well as reliable internet access. They will also need to have adequate knowledge of technology or participate with a caregiver who knows how to navigate Zoom.
- Participants who do not have access to a quiet space. Headphones are optional for this study.
- Prisoners
- Persons under the age of 40 or over the age of 80.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the short-term impact of Vocal Intonation Therapy (VIT) and Therapeutic Singing (TS) on respiratory function in patients with lung cancer. As a secondary outcome, this research will evaluate the effect of the music intervention on respiratory quality of life.
- Conditions
- Lung Cancer
- Being tested
- Vocal Intonation Therapy (VIT), Therapeutic Singing (TS)
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vocal Intonation Therapy (VIT)Behavioural
Participants will receive 12 individual sessions, four times a week (i.e., any four days of seven days) over three weeks. Each session will be held virtually for 30-minutes. Vocal Intonation Therapy is a music therapy technique consisting of breathing and vocal exercises to target respiratory function and vocal quality.
Therapeutic Singing (TS)Behavioural
Participants will receive 12 individual sessions, four times a week (i.e., any four days of seven days) over three weeks. Each session will be held virtually for 30-minutes. Therapeutic Singing is a music therapy technique used to work on the rehabilitation of vocal and respiratory function.
| Study group | Role | What they receive |
|---|---|---|
| Vocal Therapy Group | Experimental | Participants in this group will receive Vocal Intonation Therapy (VIT) and Therapeutic Singing (TS) for up to three weeks Receives: Behavioral: Vocal Intonation Therapy (VIT); Behavioral: Therapeutic Singing (TS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximum Phonation Time (MPT) in seconds
Maximum Phonation Time (MPT) measures the number of seconds a participant can sustain a phonated sound.
Measured: Baseline, up to 30-minutes (Post-Intervention)
Respiratory Rate
Measured by the number of breaths per minute
Measured: Up to 30-minutes
Change in Dyspnea measured by Dyspnea-12 Questionnaire
Scores range from 0 to 3. Higher scores suggest more severity in shortness of breath
Measured: Baseline, up to 1 month
Change in Dyspnea measured by Modified Borg Scale
Scores change from 0 to 10. Higher scores suggest more severity in shortness of breath
Measured: Baseline, up to 30-minutes (Post-Intervention)
Change in Respiratory Quality of Life measured by St.Georges Respiratory Questionnaire
A composite score will be obtained, ranging from 0 to 100. Higher scores indicate worst respiratory quality of life
Measured: Baseline, up to 1 month
Change in Dyspnea measured by Cancer Dyspnea Scale
Scores range from 1 (Not at all) to 5 (Very much). Higher scores suggest more severity of dyspnea
Measured: Baseline, up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start21 Feb 2024
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Lesiuk, University of Miami
- Investigators
- Teresa Lesiuk, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172959
- Sponsor's protocol ID
- 20230944
- Status last verified
- Sep 2024
- First submitted
- 7 Dec 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short-term Impact of Vocal Intonation Therapy (VIT) and Therapeutic Singing (TS) on Respiratory Function in Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT06172959
- Acronym / sponsor ID
- 20230944
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 15 Dec 2023 (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.
The purpose of this study is to examine the short-term impact of Vocal Intonation Therapy (VIT) and Therapeutic Singing (TS) on respiratory function in patients with lung cancer. As a secondary outcome, this research will evaluate the effect of the music intervention on respiratory quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vocal Therapy Group | Experimental | Behavioral: Vocal Intonation Therapy (VIT), Behavioral: Therapeutic Singing (TS)Participants in this group will receive Vocal Intonation Therapy (VIT) and Therapeutic Singing (TS) for up to three weeks |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants will include three patients diagnosed with lung cancer, stages I-III, who have undergone a thoracentesis or thoracotomy in the last 12 months. Thoracic surgical procedures include pulmonary lobectomy or cancer-related surgical procedure (e.g., pneumonectomy). This diagnosis must be made by the patient's oncologist and medical team.
- The age range will be 40 to 80 years old. Both female and male participants from any race and ethnicity will be included in the study.
- The study will include English and Spanish speakers only.
- Patients must have less than five years of voice training experience (e.g., choir, private voice lessons).
Key exclusion criteria (7 listed)
- Patients in respiratory failure
- Individuals with severe neurological and hearing impairments.
- Patients with diagnosed dysphonia and individuals who have undergone a laryngectomy
- Participants that do not have access to an electronic device, either an iPad, tablet, or laptop, as well as reliable internet access. They will also need to have adequate knowledge of technology or participate with a caregiver who knows how to navigate Zoom.
- Participants who do not have access to a quiet space. Headphones are optional for this study.
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 |
|---|---|---|
| Vocal Intonation Therapy (VIT)Participants will receive 12 individual sessions, four times a week (i.e., any four days of seven days) over three weeks. Each session will be held virtually for 30-minutes. Vocal Intonation Therapy is a music therapy technique consisting of breathing and vocal exercises to target respiratory function and vocal quality. | Behavioural | Vocal Therapy Group |
| Therapeutic Singing (TS)Participants will receive 12 individual sessions, four times a week (i.e., any four days of seven days) over three weeks. Each session will be held virtually for 30-minutes. Therapeutic Singing is a music therapy technique used to work on the rehabilitation of vocal and respiratory function. | Behavioural | Vocal Therapy Group |
Primary outcome
Change in Maximum Phonation Time (MPT) in seconds
Time frame: Baseline, up to 30-minutes (Post-Intervention)
Maximum Phonation Time (MPT) measures the number of seconds a participant can sustain a phonated sound.
Respiratory Rate
Time frame: Up to 30-minutes
Measured by the number of breaths per minute
Change in Dyspnea measured by Dyspnea-12 Questionnaire
Time frame: Baseline, up to 1 month
Scores range from 0 to 3. Higher scores suggest more severity in shortness of breath
Change in Dyspnea measured by Modified Borg Scale
Time frame: Baseline, up to 30-minutes (Post-Intervention)
Scores change from 0 to 10. Higher scores suggest more severity in shortness of breath
Change in Respiratory Quality of Life measured by St.Georges Respiratory Questionnaire
Time frame: Baseline, up to 1 month
A composite score will be obtained, ranging from 0 to 100. Higher scores indicate worst respiratory quality of life
Change in Dyspnea measured by Cancer Dyspnea Scale
Time frame: Baseline, up to 1 month
Scores range from 1 (Not at all) to 5 (Very much). Higher scores suggest more severity of dyspnea
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Teresa Lesiuk, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vocal Intonation Therapy (VIT) and Therapeutic Singing (TS) in people with Lung Cancer, run by University of Miami 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Maximum Phonation Time (MPT) in seconds (time frame: Baseline, up to 30-minutes (Post-Intervention)). The study lists 6 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 19 Sep 2024.