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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT03709225

Collaborator

(none)

Enrollment

Location

Arm

26.4

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Oncology Stress	Behavioral: Music-based meditation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 22, 2019

Actual Primary Completion Date :

Jan 28, 2021

Actual Study Completion Date :

Apr 5, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of adolescent and young adults recruited to participate in the music therapy program [From enrollment to end of treatment at 12 weeks]
Feasibility of participant recruitment to the music intervention
Frequency of music therapy sessions attended by participants [From enrollment to end of treatment at 12 weeks]
Feasibility of participant adherence to the music intervention
Frequency of outcome assessments completed by participants. [From enrollment to end of treatment at 12 weeks]
Feasibility of participant adherence to outcome assessments

Secondary Outcome Measures

Acceptability and Satisfaction with Participation in Music Therapy Intervention as measured by the Adapted Acceptability E - Scale. [End of treatment at 12 weeks]
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.
Post-traumatic growth [From enrollment to end of treatment at 12 weeks]
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.
Stress [From enrollment to end of treatment at 12 weeks]
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.
Pain Interference: PROMIS [From enrollment to end of treatment at 12 weeks]
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.
Fatigue [From enrollment to end of treatment at 12 weeks]
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.
Satisfaction with participation in social roles: PROMIS [From enrollment to end of treatment at 12 weeks]
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.
Pain Intensity: PROMIS [From enrollment to end of treatment at 12 weeks]
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.
Depression [From enrollment to end of treatment at 12 weeks]
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.
Anxiety [From enrollment to end of treatment at 12 weeks]
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.
Physical Function [From enrollment to end of treatment at 12 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 39 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).