NCT03709225

Brief Summary

This study is evaluating how well a music therapy program works to improve anxiety and stress in adolescents and young adults receiving cancer treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Jan 2019

Typical duration 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

First Submitted

Initial submission to the registry

October 9, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 22, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2021

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

2 years

First QC Date

October 9, 2018

Last Update Submit

November 7, 2022

Conditions

Keywords

AnxietyMusic TherapyOncologyAdolescent and Young Adults

Outcome Measures

Primary Outcomes (3)

  • Number of adolescent and young adults recruited to participate in the music therapy program

    Feasibility of participant recruitment to the music intervention

    From enrollment to end of treatment at 12 weeks

  • Frequency of music therapy sessions attended by participants

    Feasibility of participant adherence to the music intervention

    From enrollment to end of treatment at 12 weeks

  • Frequency of outcome assessments completed by participants.

    Feasibility of participant adherence to outcome assessments

    From enrollment to end of treatment at 12 weeks

Secondary Outcomes (10)

  • Acceptability and Satisfaction with Participation in Music Therapy Intervention as measured by the Adapted Acceptability E - Scale.

    End of treatment at 12 weeks

  • Post-traumatic growth

    From enrollment to end of treatment at 12 weeks

  • Stress

    From enrollment to end of treatment at 12 weeks

  • Pain Interference: PROMIS

    From enrollment to end of treatment at 12 weeks

  • Fatigue

    From enrollment to end of treatment at 12 weeks

  • +5 more secondary outcomes

Study Arms (1)

Music-based meditation

EXPERIMENTAL

The music therapy intervention consists of four in-person sessions (45 minutes) over twelve weeks. Content includes: * Introduction to music therapy and mindfulness * Music-based meditation * Using personal music to shift energy, mood, and support relaxation * Mindfulness through active music making * Discuss bringing mindfulness to daily activities

Behavioral: Music-based meditation

Interventions

The program is designed to incorporate music-based meditation practices and music making activities (e.g., guitar, drums) to help promote relaxation during cancer treatment

Music-based meditation

Eligibility Criteria

Age15 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 15 - 39 years of age
  • Have a diagnosis of any cancer
  • Have begun treatment for cancer and plan to receive active cancer treatment (e.g., radiation, chemotherapy, or oral chemotherapy) over the next eight weeks
  • Signed informed consent/assent
  • Willingness to participate in all study activities
  • Speak/read English

You may not qualify if:

  • Prognosis \< 3 months,
  • Self-report inability to physically interact with musical instruments (e.g., hold instruments)
  • Documentation of significant hearing impairment (e.g., deaf).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (4)

  • Knoerl R, Mazzola E, Woods H, Buchbinder E, Frazier L, LaCasce A, Luskin MR, Phillips CS, Thornton K, Berry DL, Ligibel J. Exploring Influencing Factors of Anxiety Improvement Following Mindfulness-Based Music Therapy in Young Adults with Cancer. J Music Ther. 2023 Jun 3;60(2):131-148. doi: 10.1093/jmt/thac017.

  • Phillips CS, Bockhoff J, Berry DL, Buchbinder E, Frazier AL, LaCasce A, Ligibel J, Luskin MR, Woods H, Knoerl R. Exploring Young Adults' Perspectives of Participation in a Mindfulness-Based Music Therapy Intervention Before and During the COVID-19 Pandemic. J Adolesc Young Adult Oncol. 2023 Aug;12(4):569-576. doi: 10.1089/jayao.2022.0090. Epub 2023 Feb 8.

  • Knoerl R, Mazzola E, Woods H, Buchbinder E, Frazier L, LaCasce A, Li BT, Luskin MR, Phillips CS, Thornton K, Berry DL, Ligibel JA. Exploring the Feasibility of a Mindfulness-Music Therapy Intervention to Improve Anxiety and Stress in Adolescents and Young Adults with Cancer. J Pain Symptom Manage. 2022 Apr;63(4):e357-e363. doi: 10.1016/j.jpainsymman.2021.11.013. Epub 2021 Dec 8.

  • Knoerl R, Phillips CS, Berfield J, Woods H, Acosta M, Tanasijevic A, Ligibel J. Lessons learned from the delivery of virtual integrative oncology interventions in clinical practice and research during the COVID-19 pandemic. Support Care Cancer. 2021 Aug;29(8):4191-4194. doi: 10.1007/s00520-021-06174-0. Epub 2021 Mar 26.

MeSH Terms

Conditions

Anxiety DisordersNeoplasms

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Robert Knoerl, PhD, RN

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 9, 2018

First Posted

October 17, 2018

Study Start

January 22, 2019

Primary Completion

January 28, 2021

Study Completion

April 5, 2021

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations