Mindfulness-Music Intervention for Adolescents and Young Adults With Cancer

Dana-Farber Cancer Institute38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Anxiety Oncology Stress

Interventions

Music-based meditationBEHAVIORAL

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

Sex: ALLMin age: 15 YearsMax age: 39 Years

Medical Language ↔ Plain English

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).

Locations (1)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Number of adolescent and young adults recruited to participate in the music therapy program

Feasibility of participant recruitment to the music intervention

Time frame: 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

Time frame: From enrollment to end of treatment at 12 weeks

Frequency of outcome assessments completed by participants.

Feasibility of participant adherence to outcome assessments

Time frame: From enrollment to end of treatment at 12 weeks

Secondary Outcomes

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.

Time frame: End of treatment at 12 weeks

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.

Time frame: 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.

Time frame: From enrollment to end of treatment at 12 weeks

Data from ClinicalTrials.gov

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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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: From enrollment to end of treatment at 12 weeks