NCT02150395

Brief Summary

This study looks at the effects of a protocolized music therapy intervention on state anxiety for patients with cancer undergoing simulation for radiation therapy. Simulation, which is an imaging and diagnostic procedure, has been identified as producing significantly high levels of anxiety in many cancer patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

2.6 years

First QC Date

May 27, 2014

Last Update Submit

May 28, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reduction in state anxiety

    pt received a protocolized music therapy intervention that included altered state induction, music driven guided visualiztion, and psychoeducation on relaxation techniques to be used during simulation for radiation therapy. Prescribed pre-recorded music program provided to be used during simulation.

    20 minutes

Secondary Outcomes (1)

  • reduced distress

    20 minutes

Study Arms (2)

music therapy

EXPERIMENTAL

pt received a protocolized music therapy intervention that included altered state induction, music driven guided visualiztion, and psychoeducation on relaxation techniques to be used during simulation for radiation therapy. Prescribed pre-recorded music program provided to be used during simulation.

Other: music therapy

control

NO INTERVENTION

no intervention

Interventions

music therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed patients with breast cancer, and newly diagnosed patients with head and neck cancer.
  • or over.
  • Fluent in English.

You may not qualify if:

  • Under 18 years.
  • Pre-existing anxiety disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Medical Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Joanne V Loewy, DA

    Beth Israel Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 27, 2014

First Posted

May 29, 2014

Study Start

July 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

May 29, 2014

Record last verified: 2014-05

Locations