Clinical trial NCT03709225: Mindfulness-Music Intervention for Adolescents and Young Adults With Cancer
Official title: Exploring the Feasibility of a Mindfulness-Music Intervention to Reduce Anxiety and Stress in Adolescents and Young Adults Receiving Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Oncology
Stress
Keywords: Anxiety
Music Therapy
Oncology
Adolescent and Young Adults
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 38
Sex: ALL
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of adolescent and young adults recruited to participate in the music therapy program
timeFrame: From enrollment to end of treatment at 12 weeks
measure: Frequency of music therapy sessions attended by participants
timeFrame: From enrollment to end of treatment at 12 weeks
measure: Frequency of outcome assessments completed by participants.
timeFrame: From enrollment to end of treatment at 12 weeks
Secondary outcomes:
measure: Acceptability and Satisfaction with Participation in Music Therapy Intervention as measured by the Adapted Acceptability E - Scale.
timeFrame: End of treatment at 12 weeks
measure: Post-traumatic growth
timeFrame: From enrollment to end of treatment at 12 weeks
measure: Stress
timeFrame: From enrollment to end of treatment at 12 weeks
measure: Pain Interference: PROMIS
timeFrame: From enrollment to end of treatment at 12 weeks
measure: Fatigue
timeFrame: From enrollment to end of treatment at 12 weeks
measure: Satisfaction with participation in social roles: PROMIS
timeFrame: From enrollment to end of treatment at 12 weeks
measure: Pain Intensity: PROMIS
timeFrame: From enrollment to end of treatment at 12 weeks
measure: Depression
timeFrame: From enrollment to end of treatment at 12 weeks
measure: Anxiety
timeFrame: From enrollment to end of treatment at 12 weeks
measure: Physical Function
timeFrame: From enrollment to end of treatment at 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Robert Knoerl, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.