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Mindfulness-Music Intervention for Adolescents and Young Adults With Cancer (MAYA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03709225
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Robert Knoerl, PhD, RN, Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Anxiety Oncology Stress Behavioral: Music-based meditation Not Applicable

Detailed Description:
This research study will test how well a twelve week music 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exploring the Feasibility of a Mindfulness-Music Intervention to Reduce Anxiety and Stress in Adolescents and Young Adults Receiving Cancer Treatment
Actual Study Start Date : January 22, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Music-based meditation

The music therapy intervention consists of four in-person sessions (45 minutes) over twelve weeks. Content includes:

  • Introduction to music therapy and mindfulness
  • Music-based meditation
  • Using personal music to shift energy, mood, and support relaxation
  • Mindfulness through active music making
  • Discuss bringing mindfulness to daily activities
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 39 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709225


Contacts
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Contact: Robert Knoerl, PhD, RN 617-632-6386 Robert_knoerl@DFCI.Harvard.edu

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Robert Knoerl, MD    617-632-6386    robert_knoerl@DFCI.Harvard.edu   
Principal Investigator: Robert Knoerl, PhD, RN         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Robert Knoerl, PhD, RN Dana-Farber Cancer Institute
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Responsible Party: Robert Knoerl, PhD, RN, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03709225    
Other Study ID Numbers: 18-341
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Knoerl, PhD, RN, Dana-Farber Cancer Institute:
Anxiety
Music Therapy
Oncology
Adolescent and Young Adults
Additional relevant MeSH terms:
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Anxiety Disorders
Neoplasms
Mental Disorders