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Completed

NCT Number: NCT03709225

Mindfulness-Music Intervention for Adolescents and Young Adults With Cancer

This study is evaluating how well a music therapy program works to improve anxiety and stress in adolescents and young adults receiving cancer treatment.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Neoplasms Oncology Stress

Age range

15 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

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

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

    Feasibility of participant recruitment to the music intervention

  2. Frequency of music therapy sessions attended by participants

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

    Feasibility of participant adherence to the music intervention

  3. Frequency of outcome assessments completed by participants.

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

    Feasibility of participant adherence to outcome assessments

Secondary outcomes

  1. Acceptability and Satisfaction with Participation in Music Therapy Intervention as measured by the Adapted Acceptability E - Scale.

    Time frame: 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.

  2. Post-traumatic growth

    Time frame: 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.

  3. Stress

    Time frame: 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.

  4. Pain Interference: PROMIS

    Time frame: 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.

  5. Fatigue

    Time frame: 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.

  6. Satisfaction with participation in social roles: PROMIS

    Time frame: 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.

  7. Pain Intensity: PROMIS

    Time frame: 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.

  8. Depression

    Time frame: 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.

  9. Anxiety

    Time frame: 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.

  10. Physical Function

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

Exploring the Feasibility of a Mindfulness-Music Intervention to Reduce Anxiety and Stress in Adolescents and Young Adults Receiving Cancer Treatment

Acronym: MAYA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 17, 2018
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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