AnxietyMAYANCT03709225
Mindfulness-Music Intervention for Adolescents and Young Adults With Cancer
A study testing Music-based meditation in people with Anxiety and Oncology, run by Dana-Farber Cancer Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 39 years
- What is being tested?
- Music-based meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2019to 5 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Prognosis < 3 months,
- Self-report inability to physically interact with musical instruments (e.g., hold instruments)
- Documentation of significant hearing impairment (e.g., deaf).
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Exploring the Feasibility of a Mindfulness-Music Intervention to Reduce Anxiety and Stress in Adolescents and Young Adults Receiving Cancer Treatment
This study is evaluating how well a music therapy program works to improve anxiety and stress in adolescents and young adults receiving cancer treatment.
Read the 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.
- Being tested
- Music-based meditation
- Keywords
- Anxiety, Music Therapy, Oncology, Adolescent and Young Adults
- Medical subject headings
- Anxiety Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music-based meditationBehavioural
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 group | Role | What they receive |
|---|---|---|
| Music-based meditation | Experimental | 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 Receives: Behavioral: Music-based meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adolescent and young adults recruited to participate in the music therapy program
Feasibility of participant recruitment to the music intervention
Measured: 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
Measured: From enrollment to end of treatment at 12 weeks
Frequency of outcome assessments completed by participants.
Feasibility of participant adherence to outcome assessments
Measured: From enrollment to end of treatment at 12 weeks
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to end of treatment at 12 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start22 Jan 2019
- Primary completion28 Jan 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Knoerl, PhD, RN, Dana-Farber Cancer Institute
- Investigators
- Robert Knoerl, PhD, RN, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709225
- Sponsor's protocol ID
- 18-341
- Acronym
- MAYA
- Status last verified
- Nov 2022
- First submitted
- 9 Oct 2018
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Knoerl R, Mazzola E, Woods H, Buchbinder E, Frazier L, LaCasce A, Luskin MR, Phillips CS, Thornton K, Berry DL, Ligibel J. Exploring Influencing Factors of Anxiety Improvement Following Mindfulness-Based Music Therapy in Young Adults with Cancer. J Music Ther. 2023 Jun 3;60(2):131-148. doi: 10.1093/jmt/thac017.
PubMed 36787235Phillips CS, Bockhoff J, Berry DL, Buchbinder E, Frazier AL, LaCasce A, Ligibel J, Luskin MR, Woods H, Knoerl R. Exploring Young Adults' Perspectives of Participation in a Mindfulness-Based Music Therapy Intervention Before and During the COVID-19 Pandemic. J Adolesc Young Adult Oncol. 2023 Aug;12(4):569-576. doi: 10.1089/jayao.2022.0090. Epub 2023 Feb 8.
PubMed 36752714Knoerl 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.
PubMed 34896280Knoerl 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.
PubMed 33772364
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Feasibility of a Mindfulness-Music Intervention to Reduce Anxiety and Stress in Adolescents and Young Adults Receiving Cancer Treatment
- ClinicalTrials.gov ID
- NCT03709225
- Acronym / sponsor ID
- MAYA / 18-341
- Keywords
- Anxiety, Music Therapy, Oncology, Adolescent and Young Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 28 Jan 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music-based meditation | Experimental | Behavioral: Music-based meditationThe 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 |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Prognosis < 3 months,
- Self-report inability to physically interact with musical instruments (e.g., hold instruments)
- Documentation of significant hearing impairment (e.g., deaf).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music-based meditationThe program is designed to incorporate music-based meditation practices and music making activities (e.g., guitar, drums) to help promote relaxation during cancer treatment | Behavioural | Music-based meditation |
Primary outcome
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
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
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
10 secondary outcomes
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
Post-traumatic growth
Time frame: From enrollment to end of treatment at 12 weeks
Stress
Time frame: From enrollment to end of treatment at 12 weeks
Pain Interference: PROMIS
Time frame: From enrollment to end of treatment at 12 weeks
Fatigue
Time frame: From enrollment to end of treatment at 12 weeks
Satisfaction with participation in social roles: PROMIS
Time frame: From enrollment to end of treatment at 12 weeks
Pain Intensity: PROMIS
Time frame: From enrollment to end of treatment at 12 weeks
Depression
Time frame: From enrollment to end of treatment at 12 weeks
Anxiety
Time frame: From enrollment to end of treatment at 12 weeks
Physical Function
Time frame: From enrollment to end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Derived from this study: PubMed 36787235Knoerl R, Mazzola E, Woods H, Buchbinder E, Frazier L, LaCasce A, Luskin MR, Phillips CS, Thornton K, Berry DL, Ligibel J. Exploring Influencing Factors of Anxiety Improvement Following Mindfulness-Based Music Therapy in Young Adults with Cancer. J Music Ther. 2023 Jun 3;60(2):131-148. doi: 10.1093/jmt/thac017.
- Derived from this study: PubMed 36752714Phillips CS, Bockhoff J, Berry DL, Buchbinder E, Frazier AL, LaCasce A, Ligibel J, Luskin MR, Woods H, Knoerl R. Exploring Young Adults' Perspectives of Participation in a Mindfulness-Based Music Therapy Intervention Before and During the COVID-19 Pandemic. J Adolesc Young Adult Oncol. 2023 Aug;12(4):569-576. doi: 10.1089/jayao.2022.0090. Epub 2023 Feb 8.
- Derived from this study: PubMed 34896280Knoerl 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.
- Derived from this study: PubMed 33772364Knoerl 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.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Knoerl, PhD, RN principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music-based meditation in people with Anxiety and Oncology, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03709225, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.