Music of Choice to Decrease Anxiety During Radiation Treatment

NCT03527225 | Completed DMC

• 2 other identifiers: IRB201703352OCR17059
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Cancer

Keywords

Music Therapy; First Radiotherapy; Anxiety Reduction; Psychosocial Functioning; State - Trait Anxiety Inventory (STAI); Symptom Distress Thermometer (SDT)

Outcome Measures

Primary Outcomes (1)

• Mean change of STAI Score from within 2 hours prior to first RT session to 2 hours post first RT session.

  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.

  baseline

Secondary Outcomes (5)

• Mean change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session.

  baseline

• Magnitude change of STAI Score

  baseline

• Magnitude change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session.

  baseline

• STAI "High to Low Score" Change from within 2 hours prior to first RT session to 2 hours post first RT session.

  baseline

• SDT "High to Low Score" Change from within 2 hours prior to first RT session to 2 hours post first RT session.

  baseline

Study Arms (2)

Music

EXPERIMENTAL

Patients randomized to the music intervention arm will select a preferred genre of music from an internet based resource.

Other: Music

No Music

NO INTERVENTION

These patient's will have no music playing during the first radiotherapy session.

Interventions

Music OTHER

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.

Music

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Multiple studies document a higher rate of psychological distress in female cancer patients.The study is limited to females to decrease confounding prognostic factors related to anxiety during cancer therapy. By restricting enrollment to women in this study, is to gain proof of concept that the intervention is effective and can be determined with a smaller sample size.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to receive radiotherapy for malignant tumor
• ECOG Performance Status 0-4
• Fluent in English Language
• Patients must be deemed able to comply with the treatment plan.
• Patients must provide study specific informed consent prior to study entry.

You may not qualify if:

• Prior history of radiation therapy

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Health Cancer Center

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Neoplasms

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Natalie A. Lockney, M.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: May 17, 2018
• Study Start: January 22, 2018
• Primary Completion: January 15, 2020
• Study Completion: January 15, 2020
• Last Updated: March 13, 2020

Record last verified: 2020-03

Locations

US (1)