Mindfulness-Music Intervention for Adolescents and Young Adults With Cancer

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

Detailed Description
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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.

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

Conditions
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Anxiety, Oncology, Stress

Intervention / Treatment
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* Behavioral: Music-based meditation


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music-based meditation<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Music Therapy, Oncology, Adolescent and Young Adults