Anxiety, Cancer
Conditions
Keywords
Music Therapy, First Radiotherapy, Anxiety Reduction, Psychosocial Functioning, State - Trait Anxiety Inventory (STAI), Symptom Distress Thermometer (SDT)
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.
Interventions
OTHERMusic
The patient's preferred music will be played during the first radiotherapy treatment session from speakers located inside the treatment room. The duration of the music will be 10 to 20 minutes. The music will be turned off at the patient's request if it bothers them. Length of music playing and if the patient requested that it be turned off, will be recorded.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change of STAI Score from within 2 hours prior to first RT session to 2 hours post first RT session. | baseline | Percent change in mean anxiety score as measured with the State-Trait Anxiety Inventory (STAI) questionnaire. Assessed by the mean value (pre minus post radiotherapy STAI score) divided by mean pre-treatment score multiplied by 100. A score of 39-40 on each subset suggests clinically significant anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session. | baseline | Percentage change in mean anxiety score as measured with the Symptom Distress Thermometer (SDT). Scale of 0 - 10; with 10 being clinically significant distress. |
| Magnitude change of STAI Score | baseline | The magnitude of change in anxiety score of STAI in high anxiety patients (pre-treatment STAI ≥ 40) as a result of listening to music during the first radiotherapy session. |
| Magnitude change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session. | baseline | The magnitude of change in anxiety score of SDT in high anxiety patients (pre-treatment SDT ≥ 4) as a result of listening to music during the first radiotherapy session. Scale of 0 - 10; with 10 being clinically significant distress. |
| STAI High to Low Score Change from within 2 hours prior to first RT session to 2 hours post first RT session. | baseline | The number and percentage of patients who drop from a high to low anxiety level in both intervention groups using STAI scores. A score of 39-40 on each subset suggests clinically significant anxiety. |
| SDT High to Low Score Change from within 2 hours prior to first RT session to 2 hours post first RT session. | baseline | The number and percentage of patients who drop from a high to low anxiety level in both intervention groups using SDT scores. Scale of 0 - 10; with 10 being clinically significant distress. |
Countries
United States
Outcome results
None listed