NCT02261558

Brief Summary

This study will investigate the impact of music therapy on newly diagnosed patients with cancer undergoing chemotherapy. Measurements used at baseline, middle and end of first cycle will be the Resiliency Scale (Wagnild and Young 1993); The HADS scale (hospital anxiety depression scale, Zigmond and Snaith 1983 )and and The CAS scale for pain (Color Analysis Scale).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable anxiety

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

7.8 years

First QC Date

July 24, 2014

Last Update Submit

January 28, 2020

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

  • Resiliency Scale

    Research indicates that the majority of patients undergoing chemotherapy have extreme anxiety, particularly in the first round. . The music therapy implemented in the 2 treatment arms will be live and evaluated to meet the patients' culture, past medical history, past trauma upon assessment of psychological stressors. Resilience as measured through quantitative scale Wagnild, \& Young (1993) that views daily activities and coping strategies that are often compromised with diseases that require frequent treatments.

    At 6 months

Secondary Outcomes (8)

  • Hospital Anxiety and Depression Scale (HADS)

    At 6 months

  • Music Psychotherapy Data Tool

    At 6 months

  • Visual Analogue Scale (VAS)

    At 1 month

  • Visual Analogue Scale (VAS)

    At 3 months

  • Visual Analogue Scale (VAS)

    At 6 months

  • +3 more secondary outcomes

Study Arms (3)

Clinical Improvisation Instrumental Music Therapy

EXPERIMENTAL

Clinical Music Therapy session, 20 minutes. Focus on instrumental improvisation

Other: Clinical Improvisation Instrumental Music Therapy

Clinical Vocal Improvisation

EXPERIMENTAL

Clinical Music Therapy session, 20 minutes. Focus on vocal improvisation

Other: Clinical Vocal Improvisation

Control Group

NO INTERVENTION

Participants enrolled in control group will complete the same study design, without having a clinical music improvisation

Interventions

Clinical Improvisation Instrumental Music TherapyOTHER

Select an instrument of choice (and instruments for caregiver/s if applicable) Play/improvise and expand playing 10 minutes, inclusive of clinical improvisation (melody, harmony, timbre, and rhythmic idioms) where musical communication will be fostered and therapeutic goals will be addressed by the therapist in the music. Closure through verbal reflection and sharing (5 minutes)

Clinical Improvisation Instrumental Music Therapy
Clinical Vocal ImprovisationOTHER

\* 5 minutes of warm up. Select a few favorite songs of choice. Play/improvise and expand playing 10 minutes, inclusive of clinical improvisation (melody, harmony, timbre, and rhythmic idioms) where musical communication will be fostered and therapeutic goals will be addressed by the therapist in the music. Identify themes and issues addressed and/or paralleled in the song and/or within the self Closure through verbal reflection and sharing (5 minutes)

Clinical Vocal Improvisation

Eligibility Criteria

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

You may qualify if:

  • and older
  • diagnosed with breast cancer, lung cancer, or gastro-intestinal cancer

You may not qualify if:

  • Under 18
  • past cancer(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Related Publications (2)

  • Bradt J, Dileo C, Myers-Coffman K, Biondo J. Music interventions for improving psychological and physical outcomes in people with cancer. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD006911. doi: 10.1002/14651858.CD006911.pub4.

    PMID: 34637527DERIVED

  • Mondanaro JF, Sara GA, Thachil R, Pranjic M, Rossetti A, EunHye Sim G, Canga B, Harrison IB, Loewy JV. The Effects of Clinical Music Therapy on Resiliency in Adults Undergoing Infusion: A Randomized, Controlled Trial. J Pain Symptom Manage. 2021 Jun;61(6):1099-1108. doi: 10.1016/j.jpainsymman.2020.10.032. Epub 2020 Nov 2.

    PMID: 33152443DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Joanne Loewy, MT-BC

    Mount Sinai Beth Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2014

First Posted

October 10, 2014

Study Start

June 1, 2011

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

January 30, 2020

Record last verified: 2020-01

Locations

US(1)