Mindfulness-Music Intervention for Adolescents and Young Adults With Cancer

Anxiety Clinical Trial

— MAYA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03709225
• Other study ID #: 18-341
• Status: Completed
• Phase: N/A
• Start date: January 22, 2019
• Est. completion date: April 5, 2021

Study information

• Verified date: November 2022
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 5, 2021
• Est. primary completion date: January 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 39 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Neoplasms
• Oncology
• Stress

Intervention

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

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Frequency of outcome assessments completed by participants.	Feasibility of participant adherence to outcome assessments	From enrollment to end of treatment at 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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