The Short-term Impact of Vocal Intonation Therapy (VIT) and Therapeutic Singing (TS) on Respiratory Function in Patients With Lung Cancer

February 22, 2024 updated by: Teresa Lesiuk, University of Miami
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Recruiting
        • University of Miami
        • Contact:
        • Principal Investigator:
          • Teresa Lesiuk, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vocal Therapy Group
Participants in this group will receive Vocal Intonation Therapy (VIT) and Therapeutic Singing (TS) for up to three weeks
Behavioral: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, up to 30-minutes (Post-Intervention)
Respiratory Rate
Time Frame: Up to 30-minutes
Measured by the number of breaths per minute
Up to 30-minutes
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
Baseline, up to 1 month
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
Baseline, up to 30-minutes (Post-Intervention)
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
Baseline, up to 1 month
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
Baseline, up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Teresa Lesiuk, PhD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20230944

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings