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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2022
Source Dana-Farber Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Music-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

Locations

Country Name City State
United States Dana Farber Cancer Institute Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

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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