Clinical trial NCT03527225: Music of Choice to Decrease Anxiety During Radiation Treatment
Official title: A Randomized Trial of Music to Decrease Anxiety in Women Starting Radiation Therapy for Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Cancer
Keywords: Music Therapy
First Radiotherapy
Anxiety Reduction
Psychosocial Functioning
State - Trait Anxiety Inventory (STAI)
Symptom Distress Thermometer (SDT)
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Consented, eligible female subjects to be randomized to "Music" or "No Music" to evaluate pre and post treatment anxiety level via STAI and SDT anxiety questionnaire at their first radiotherapy treatment for cancer.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary hypothesis of the study is that listening to music will reduce anxiety in female cancer patients during the first radiotherapy treatment session.

Detailed description: Receiving radiotherapy induces anxiety in at least 1/3 of patients who did not have a previously existing anxiety condition1. Female gender is a positive predictive factor for psychosocial decline during radiotherapy. One-fourth of patients disrupt their planned radiotherapy treatment course due to anxiety. Music therapy has demonstrated effectiveness in reducing anxiety when implemented in other medical settings including mechanical ventilation, burn debridement and venipuncture in pediatric patients. There have been some trials which have found a reduction in anxiety when pre-recorded music along with other relaxation techniques have been implemented during radiotherapy. This trial seeks to investigate the benefit of pre-recorded music alone in reducing anxiety experienced during the first radiotherapy treatment session in female cancer patients.

Eligibility criteria: Inclusion Criteria:

* Scheduled to receive radiotherapy for malignant tumor
* ECOG Performance Status 0-4
* Fluent in English Language
* Inclusion in this study will not be based on race or ethnicity
* Patients must be deemed able to comply with the treatment plan.
* Patients must provide study specific informed consent prior to study entry.

Exclusion Criteria:

* Prior history of radiation therapy

Primary outcomes:
measure: Mean change of STAI Score from within 2 hours prior to first RT session to 2 hours post first RT session.
timeFrame: baseline
Secondary outcomes:
measure: Mean change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session.
timeFrame: baseline
measure: Magnitude change of STAI Score
timeFrame: baseline
measure: Magnitude change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session.
timeFrame: baseline
measure: STAI "High to Low Score" Change from within 2 hours prior to first RT session to 2 hours post first RT session.
timeFrame: baseline
measure: SDT "High to Low Score" Change from within 2 hours prior to first RT session to 2 hours post first RT session.
timeFrame: baseline
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Health Cancer Center
state: Florida
Study officials:
affiliation: University of Florida
name: Natalie A. Lockney, M.D.
role: PRINCIPAL_INVESTIGATOR
References: