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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06172959
• Other study ID #: 20230944
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2024
• Est. completion date: October 30, 2024

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: Teresa Lesiuk, PhD
• Phone: 305-284-3650
• Email: tlesiuk[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3
• Est. completion date: October 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Respiratory Rate	Measured by the number of breaths per minute	Up to 30-minutes
Primary	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
Primary	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)
Primary	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
Primary	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