NCT07729384

Brief Summary

This clinical trial tests the feasibility and acceptability of the Strengthening Teen Brain Resilience Using Music (STRUM) intervention to improve radiation induced cognitive decline for adolescents undergoing radiation therapy for cancer treatment. Adolescents treated with radiation therapy for cancer often experience persistent cognitive deficits and reduced brain resilience or the ability to preserve cognitive and emotional functioning despite stressors. Musical instrument training has been shown to enhance memory, academic skills, and emotional well-being in youth. Although guitars are often the most preferred instrument, ukuleles offer greater accessibility due to their simplicity, affordability, and suitability for younger users. The STRUM intervention consists of virtual active music therapy ukulele lessons, which may be a feasible and acceptable way to improve radiation induced cognitive decline for adolescents undergoing radiation therapy for cancer treatment.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
25mo left

Started Oct 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

2.1 years

First QC Date

July 22, 2026

Last Update Submit

July 22, 2026

Conditions

Outcome Measures

Primary Outcomes (7)

  • Percentage of eligible participants who consent to participate in this study (feasibility)

    Feasibility defined as achieving a ≥ 70% consent rate among eligible participants.

    At time of enrollment

  • Proportion of STRUM sessions completed (feasibility)

    Participants will receive 10 weekly 30-minute virtual ukulele lessons over ten weeks. Basic descriptive statistical analyses will be performed.

    Up to 10 weeks

  • Average weekly practice minutes

    Assessed by patient self-report. Participants will be encouraged to practice their skills independently for at least 90 minutes per week. Basic descriptive statistical analyses will be performed.

    Up to 10 weeks

  • Percentage of participants who complete ≥ 90% of the measures at each timepoint (feasibility)

    Basic descriptive statistical analyses will be performed.

    Baseline, week 6, week 12, week 20

  • Acceptability of the Strengthening Teen Brain Resilience Using Music (STRUM) intervention

    Defined as mean Acceptability of Intervention Measure (AIM) score of ≥ 3/4, supported by exit interview feedback. Basic descriptive statistical analyses will be performed. The AIM is a study-specific measure that consists of 4 questions, each answered on a scale of 1 (completely disagree) to 5 (completely agree). Higher scores indicate greater acceptability.

    Approximately 2 weeks following end of intervention (week 12)

  • Participant perspective on meaningfulness of the STRUM intervention

    Assessed by exit interview feedback. Participants will complete semi-structured exit interviews (approximately 30-minute duration). Exit interview transcripts will be analyzed and coded using thematic analyses. Thematic findings will be used to refine the intervention design and delivery.

    Approximately 2 weeks following end of intervention (week 12)

  • Change in brain resilience

    Assessed by cognitive testing using the BrainCheck Assess™ digital platform. Each testing session should take approximately 15 minutes. Standard aggregate scores range from 0-200 with lower scores generally suggesting greater cognitive impairment.

    Baseline, week 6, week 12, week 20

Study Arms (1)

Supportive care (STRUM sessions)

EXPERIMENTAL

Patients receive a ukulele, tuner, and songbook and attend virtually delivered ukulele lessons over 30 minutes each, once weekly, for 10 weeks. Intervention sessions are structured with stair-stepping difficulty with each lesson concluding with learning a new song. Ten optional supplemental video-recorded lessons (approximately 15 minutes each) will be available for patients to view asynchronously and use for independent practice between weekly sessions. Patients are encouraged to practice their skills independently for at least 90 minutes per week. At the conclusion of the study, patients may attend an optional virtual "Encore Concert Event" remotely, featuring audio-video clips compiled from participants' lessons.

Other: InterviewProcedure: Music TherapyOther: Survey Administration

Interventions

Ancillary studies

Supportive care (STRUM sessions)
Music TherapyPROCEDURE

Attend STRUM sessions

Supportive care (STRUM sessions)

Ancillary studies

Supportive care (STRUM sessions)

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged 12-17 years at the time of enrollment
  • Receiving initial radiation therapy (RT) for cancer treatment with curative intent at the Mayo Clinic Arizona
  • Able to provide assent
  • Able to read and write in English
  • Have access to an electronic device with videoconferencing capability

You may not qualify if:

  • Less than three-month prognosis
  • Past history of RT
  • Self-reported visual, hearing, or cognitive impairment impeding the ability to complete the STRUM intervention
  • Prior receipt of ukulele or guitar lessons
  • Actively receiving musical instrument lessons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Interventions

Interviews as TopicMusic Therapy

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthSensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • C. Robert Bennett, PhD, RN

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Bennett, PhD, RN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2026

First Posted

July 27, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

July 27, 2026

Record last verified: 2026-07

Locations