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

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: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Vocal Intonation Therapy (VIT); Behavioral: Therapeutic Singing (TS)

• Study Type: Interventional
• Enrollment (Estimated): 3
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Teresa Lesiuk, PhD; Phone Number: 305-284-3650; Email: tlesiuk@miami.edu

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Recruiting
      • University of Miami
      • Contact: Lianet Bujosa Giraldino, BA; Phone Number: 305-284-3650; Email: lxb2233@miami.edu
      • Principal Investigator: Teresa Lesiuk, PhD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Change in Maximum Phonation Time (MPT) in seconds	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	Measured by the number of breaths per minute	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	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	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	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	Baseline, up to 1 month

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Teresa Lesiuk, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID 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