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Completed

NCT Number: NCT06172959

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.

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Coral Gables, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. Respiratory Rate

    Time frame: Up to 30-minutes

    Measured by the number of breaths per minute

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 15, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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