Anxiety, Oncology, Stress
Conditions
Keywords
Anxiety, Music Therapy, Oncology, Adolescent and Young Adults
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.
Interventions
BEHAVIORALMusic-based meditation
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
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 39 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed