Anxiety Clinical Trial
— MAYAOfficial title:
Exploring the Feasibility of a Mindfulness-Music Intervention to Reduce Anxiety and Stress in Adolescents and Young Adults Receiving Cancer Treatment
NCT number | NCT03709225 |
Other study ID # | 18-341 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 22, 2019 |
Est. completion date | April 5, 2021 |
Verified date | November 2022 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is evaluating how well a music therapy program works to improve anxiety and stress in adolescents and young adults receiving cancer treatment.
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). |
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute |
United States,
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 |
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