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

Primary Purpose

Anxiety, Oncology, Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music-based meditation
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Anxiety, Music Therapy, Oncology, Adolescent and Young Adults

Eligibility Criteria

15 Years - 39 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Music-based meditation

Arm Description

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

Outcomes

Primary Outcome Measures

Number of adolescent and young adults recruited to participate in the music therapy program
Feasibility of participant recruitment to the music intervention
Frequency of music therapy sessions attended by participants
Feasibility of participant adherence to the music intervention
Frequency of outcome assessments completed by participants.
Feasibility of participant adherence to outcome assessments

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 9, 2018
Last Updated
November 7, 2022
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03709225
Brief Title
Mindfulness-Music Intervention for Adolescents and Young Adults With Cancer
Acronym
MAYA
Official Title
Exploring the Feasibility of a Mindfulness-Music Intervention to Reduce Anxiety and Stress in Adolescents and Young Adults Receiving Cancer Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 22, 2019 (Actual)
Primary Completion Date
January 28, 2021 (Actual)
Study Completion Date
April 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Oncology, Stress
Keywords
Anxiety, Music Therapy, Oncology, Adolescent and Young Adults

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music-based meditation
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Music-based meditation
Intervention Description
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 Measure Information:
Title
Number of adolescent and young adults recruited to participate in the music therapy program
Description
Feasibility of participant recruitment to the music intervention
Time Frame
From enrollment to end of treatment at 12 weeks
Title
Frequency of music therapy sessions attended by participants
Description
Feasibility of participant adherence to the music intervention
Time Frame
From enrollment to end of treatment at 12 weeks
Title
Frequency of outcome assessments completed by participants.
Description
Feasibility of participant adherence to outcome assessments
Time Frame
From enrollment to end of treatment at 12 weeks
Secondary Outcome Measure Information:
Title
Acceptability and Satisfaction with Participation in Music Therapy Intervention as measured by the Adapted Acceptability E - Scale.
Description
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
Title
Post-traumatic growth
Description
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
Title
Stress
Description
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
Title
Pain Interference: PROMIS
Description
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
Title
Fatigue
Description
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
Title
Satisfaction with participation in social roles: PROMIS
Description
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
Title
Pain Intensity: PROMIS
Description
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
Title
Depression
Description
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
Title
Anxiety
Description
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
Title
Physical Function
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Knoerl, PhD, RN
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34896280
Citation
Knoerl R, Mazzola E, Woods H, Buchbinder E, Frazier L, LaCasce A, Li BT, Luskin MR, Phillips CS, Thornton K, Berry DL, Ligibel JA. Exploring the Feasibility of a Mindfulness-Music Therapy Intervention to Improve Anxiety and Stress in Adolescents and Young Adults with Cancer. J Pain Symptom Manage. 2022 Apr;63(4):e357-e363. doi: 10.1016/j.jpainsymman.2021.11.013. Epub 2021 Dec 8.
Results Reference
derived
PubMed Identifier
33772364
Citation
Knoerl R, Phillips CS, Berfield J, Woods H, Acosta M, Tanasijevic A, Ligibel J. Lessons learned from the delivery of virtual integrative oncology interventions in clinical practice and research during the COVID-19 pandemic. Support Care Cancer. 2021 Aug;29(8):4191-4194. doi: 10.1007/s00520-021-06174-0. Epub 2021 Mar 26.
Results Reference
derived

Learn more about this trial

Mindfulness-Music Intervention for Adolescents and Young Adults With Cancer

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