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

NCT06172959 | Completed

• 1 other identifier: 20230944
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Vocal Therapy Group

EXPERIMENTAL

Participants in this group will receive Vocal Intonation Therapy (VIT) and Therapeutic Singing (TS) for up to three weeks

Behavioral: Vocal Intonation Therapy (VIT); Behavioral: Therapeutic Singing (TS)

Interventions

Vocal Intonation Therapy (VIT) BEHAVIORAL

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.

Vocal Therapy Group

Therapeutic Singing (TS) BEHAVIORAL

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.

Vocal Therapy Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Teresa Lesiuk, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: February 21, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)