Mindfulness-Music Intervention for Adolescents and Young Adults With Cancer (MAYA)

Exploring the Feasibility of a Mindfulness-Music Intervention to Reduce Anxiety and Stress in Adolescents and Young Adults Receiving Cancer Treatment

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

Study Overview

• Status: Completed
• Conditions: Stress; Anxiety; Oncology
• Intervention / Treatment: Behavioral: Music-based meditation

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 39 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music-based meditation; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability and Satisfaction with Participation in Music Therapy Intervention as measured by the Adapted Acceptability E - Scale.	Each item of the Adapted Acceptability E - Scale is scored individually on a 1 - 5 scale, with higher scores representing greater acceptability and satisfaction with the music therapy intervention.	End of treatment at 12 weeks
Post-traumatic growth	Change in Post Traumatic Growth Inventory - Short Form score from enrollment to the end of treatment at 12 weeks. Total scores on the Post Traumatic Growth Inventory Short Form range from 0 - 50, with higher scores representing greater post-traumatic growth.	From enrollment to end of treatment at 12 weeks
Stress	Change in Perceived Stress Scale score from enrollment to the end of treatment at 12 weeks. The scale is scored from 0 - 40, with higher scores representing greater stress.	From enrollment to end of treatment at 12 weeks
Pain Interference: PROMIS	Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a score from enrollment to the end of treatment at 12 weeks. Total scores range from 41.6 - 75.6, with higher scores representing worse pain interference.	From enrollment to end of treatment at 12 weeks
Fatigue	Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 4a score from enrollment to the end of treatment at 12 weeks. Total scores range from 33.7 - 75.8, with higher scores representing worse fatigue.	From enrollment to end of treatment at 12 weeks
Satisfaction with participation in social roles: PROMIS	Change in Patient Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Participation in Social Roles 4a score from enrollment to end of treatment at 12 weeks. Total scores range from 29 - 64.1, with higher scores representing worse satisfaction with participation in social roles.	From enrollment to end of treatment at 12 weeks
Pain Intensity: PROMIS	Change in 0 - 10 numerical rating scale of average pain (included in Patient Reported Outcomes Measurement Information System (PROMIS) - 29 profile)) from enrollment to end of treatment at 12 weeks. Total scores range from 0 - 10, with higher scores representing worse pain.	From enrollment to end of treatment at 12 weeks
Depression	Change in Patient Reported Outcomes Measurement Information System (PROMIS) Depression 4a score from enrollment to the end of treatment at 12 weeks. Total scores range from 41.0 - 79.4, with higher scores representing worse depression.	From enrollment to end of treatment at 12 weeks
Anxiety	Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a score from enrollment to the end of treatment at 12 weeks. Total scores range from 40.3 - 81.6, with higher scores representing worse anxiety.	From enrollment to end of treatment at 12 weeks
Physical Function	Change in Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function 4a score from enrollment to the end of treatment at 12 weeks. Total scores range from 22.9 - 56.9, with higher scores representing worse physical function.	From enrollment to end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Robert Knoerl, PhD, RN, Dana-Farber Cancer Institute

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2019
• Primary Completion (Actual): January 28, 2021
• Study Completion (Actual): April 5, 2021

Study Registration Dates

• First Submitted: October 9, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Anxiety; Oncology; Music Therapy; Adolescent and Young Adults
• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms; Anxiety Disorders
• Other Study ID Numbers: 18-341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No