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

Not Applicable

Recruiting

• Conditions: Lung Cancer
• Interventions: Behavioral: Vocal Intonation Therapy (VIT); Behavioral: Therapeutic Singing (TS)

• Registration Number: NCT06172959
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-15
• Status Verified: 2024-02
• Study Start: 2024-02-21
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-26
• Primary Completion: 2024-09-30
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Dyspnea measured by Modified Borg Scale	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	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 Maximum Phonation Time (MPT) in seconds	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	Up to 30-minutes	Measured by the number of breaths per minute
Change in Dyspnea measured by Cancer Dyspnea Scale	Baseline, up to 1 month	Scores range from 1 (Not at all) to 5 (Very much). Higher scores suggest more severity of dyspnea
Change in Dyspnea measured by Dyspnea-12 Questionnaire	Baseline, up to 1 month	Scores range from 0 to 3. Higher scores suggest more severity in shortness of breath

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Coral Gables, Florida, United States