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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music-based meditation | Experimental | The music therapy intervention consists of four in-person sessions (45 minutes) over twelve weeks. Content includes:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music-based meditation | Behavioral | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Knoerl, PhD, RN | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36787235 | Derived | Knoerl R, Mazzola E, Woods H, Buchbinder E, Frazier L, LaCasce A, Luskin MR, Phillips CS, Thornton K, Berry DL, Ligibel J. Exploring Influencing Factors of Anxiety Improvement Following Mindfulness-Based Music Therapy in Young Adults with Cancer. J Music Ther. 2023 Jun 3;60(2):131-148. doi: 10.1093/jmt/thac017. | |
| 36752714 | Derived |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 6, 2021 | May 4, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| 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 |
| Phillips CS, Bockhoff J, Berry DL, Buchbinder E, Frazier AL, LaCasce A, Ligibel J, Luskin MR, Woods H, Knoerl R. Exploring Young Adults' Perspectives of Participation in a Mindfulness-Based Music Therapy Intervention Before and During the COVID-19 Pandemic. J Adolesc Young Adult Oncol. 2023 Aug;12(4):569-576. doi: 10.1089/jayao.2022.0090. Epub 2023 Feb 8. |
| 34896280 | Derived | Knoerl R, Mazzola E, Woods H, Buchbinder E, Frazier L, LaCasce A, Li BT, Luskin MR, Phillips CS, Thornton K, Berry DL, Ligibel JA. Exploring the Feasibility of a Mindfulness-Music Therapy Intervention to Improve Anxiety and Stress in Adolescents and Young Adults with Cancer. J Pain Symptom Manage. 2022 Apr;63(4):e357-e363. doi: 10.1016/j.jpainsymman.2021.11.013. Epub 2021 Dec 8. |
| 33772364 | Derived | Knoerl R, Phillips CS, Berfield J, Woods H, Acosta M, Tanasijevic A, Ligibel J. Lessons learned from the delivery of virtual integrative oncology interventions in clinical practice and research during the COVID-19 pandemic. Support Care Cancer. 2021 Aug;29(8):4191-4194. doi: 10.1007/s00520-021-06174-0. Epub 2021 Mar 26. |