Mindfulness-Music Intervention for Adolescents and Young Adults With Cancer
- Conditions
- AnxietyStressOncology
- Interventions
- Behavioral: Music-based meditation
- Registration Number
- NCT03709225
- Lead Sponsor
- Dana-Farber Cancer Institute
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Music-based meditation 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
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
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.
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.
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.
Trial Locations
- Locations (1)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States