AnxietyNCT05911269
Feasibility of Virtual, Tailored, Music-Based Relaxation for Anxiety in Adolescent and Young Adult Cancer Survivors
A study testing TiMBRe in people with Anxiety, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
Demonstrate the feasibility of conducting an eight-week, (45 min/week), theory driven, virtually-delivered, tailored music-based relaxation (TiMBRe) intervention to decrease anxiety in adolescent and young adult (AYA) cancer survivors with clinically-relevant anxiety. Read more about this study
- Who is it for?
- Ages 15 to 39 years
- Conditions the study is for
- Anxiety
- What is being tested?
- TiMBRe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2025to 24 Jul 2026
- 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
- 15 - 39 years old
- at least one month post cancer treatment
- report clinically relevant anxiety in the past seven days (PROMIS Anxiety 4a scores ≥ 55)35
- speak/read English.
Who cannot join
- prognosis less than 3 months
- documentation of significant hearing impairment
- plan to receive surgery, radiation, or chemotherapy for cancer treatment during the study period
- plans in place to begin new psychosocial (i.e., cognitive behavioral therapy14 or mindfulness-based stress reduction15) or pharmacological treatments for anxiety during the study. Although, participants may continue psychosocial or pharmacological treatments for anxiety if the treatments were initiated at least eight weeks prior to study enrollment, the dose has not changed, and they report clinically relevant anxiety in the last week.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Feasibility of Virtual, Tailored, Music-Based Relaxation for Anxiety in Adolescent and Young Adult Cancer Survivors
Demonstrate the feasibility of conducting an eight-week, (45 min/week), theory driven, virtually-delivered, tailored music-based relaxation (TiMBRe) intervention to decrease anxiety in adolescent and young adult (AYA) cancer survivors with clinically-relevant anxiety.
Read the detailed description
Initially Sessions 7 and 8 were both body percussion; however, the 04FEB2025 changed this to Session 7 will be body percussion and session 8 will be selected by the participant. This will allow for more tailoring of the intervention.
- Conditions
- Anxiety
- Being tested
- TiMBRe, Control
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiMBReOther
1 \& 2 Music Listening
- Live music played by the music therapist (e.g., guitar, voice) and AYA selected music will be used to facilitate attention to the present moment and provide cues for breathing/relaxation. 3 \& 4 Music Facilitated Breathing
- The therapist will lead participants in music facilitated breathing exercises using rhythmic features of the music to cue structured breathing for relaxation and self-awareness 5 \& 6 Music Facilitated Progressive Muscle Relaxation for Stress Reduction
- Using music as a structured auditory cue for tensing and releasing of muscles. 7 Body Percussion
- The therapist will lead participants in a hands-on body percussion activity to bring attention to the sound of rhythm, sensation in their hands and body. 8 Participants Choice
- will be selected by the participant.
ControlOther
Standard of care study staff calls and cancer survivorship resources
| Study group | Role | What they receive |
|---|---|---|
| TiMBRe | Experimental | an eight-week, (45 min/week), theory driven, virtually-delivered, tailored music-based relaxation (TiMBRe) intervention to decrease anxiety in AYA cancer survivors with clinically-relevant anxiety. Receives: Other: TiMBRe |
| Attention-Control | Active comparator | Standard of care study staff calls and cancer survivorship resources Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of TiMBRe
mean scores for the Acceptability E-scale Items are ≥ 4/5
Measured: up to 8 weeks post start of intervention
Demand of TiMBRe
percent of patients recruited over three years
Measured: up to 3 years from start of study
Adherence to TiMBRe
percent of TiMBRe participants to complete the baseline and 8 weeks patient report measures
Measured: From enrollment to end of treatment at 8 weeks
Practicality of TiMBRe
percent of TiMBRe group participants self-report practicing music-based relaxation skills for at least 10 minutes on at least three days per week
Measured: From enrollment to end of treatment at 8 weeks
Secondary outcomes (2)
Identification of facilitators and barriers to virtual TiMBRe participation
Interviews will be transcribed by a professional HIPAA compliant transcription agency. We will analyze interview data using inductive content analysis.74 Transcripts will be entered into NVivo Qualitative Data Analysis Software (QSR International, Melbourne, Australia). The study team will read transcripts to derive codes, discuss labels to group codes into categories, and identify major themes and corresponding exemplar quotes. The interviewer will write reflexive memos after each interview and review memos with corresponding audio recordings to discern linkages, gaps, and questions.
Measured: up to 8 weeks post start of intervention
Change in Anxiety management
determine the preliminary impact of the eight-week virtual TiMBRe intervention, relative to the control, on improving anxiety (PROMIS Anxiety 4a, 40.3 - 81.6; higher scores = worse anxiety) utilizing data collected at baseline, four weeks, and eight weeks. Reporting the change from baseline to eight weeks.
Measured: at baseline and eight weeks post initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start21 Jan 2025
- Primary completion24 Jul 2026
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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
- Randomised
- Intervention model
- Sequential
- Model description
- Explanatory-Sequential Mixed Methods Study
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert Knoerl, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911269
- Sponsor's protocol ID
- UMCC 2023.024
- Other IDs
- HUM00231408, R34CA286712
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2023
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Feasibility of Virtual, Tailored, Music-Based Relaxation for Anxiety in Adolescent and Young Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT05911269
- Acronym / sponsor ID
- UMCC 2023.024
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 24 Jul 2026 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 20 Jun 2023 (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.
Demonstrate the feasibility of conducting an eight-week, (45 min/week), theory driven, virtually-delivered, tailored music-based relaxation (TiMBRe) intervention to decrease anxiety in adolescent and young adult (AYA) cancer survivors with clinically-relevant anxiety.
Detailed description
Initially Sessions 7 and 8 were both body percussion; however, the 04FEB2025 changed this to Session 7 will be body percussion and session 8 will be selected by the participant. This will allow for more tailoring of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Explanatory-Sequential Mixed Methods Study
| Arm | Type | Receives |
|---|---|---|
| TiMBRe | Experimental | Other: TiMBRean eight-week, (45 min/week), theory driven, virtually-delivered, tailored music-based relaxation (TiMBRe) intervention to decrease anxiety in AYA cancer survivors with clinically-relevant anxiety. |
| Attention-Control | Active comparator | Other: ControlStandard of care study staff calls and cancer survivorship resources |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 15 - 39 years old
- at least one month post cancer treatment
- report clinically relevant anxiety in the past seven days (PROMIS Anxiety 4a scores ≥ 55)35
- speak/read English.
Key exclusion criteria (4 listed)
- prognosis less than 3 months
- documentation of significant hearing impairment
- plan to receive surgery, radiation, or chemotherapy for cancer treatment during the study period
- plans in place to begin new psychosocial (i.e., cognitive behavioral therapy14 or mindfulness-based stress reduction15) or pharmacological treatments for anxiety during the study. Although, participants may continue psychosocial or pharmacological treatments for anxiety if the treatments were initiated at least eight weeks prior to study enrollment, the dose has not changed, and they report clinically relevant anxiety in the last week.
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 |
|---|---|---|
| TiMBRe1 \& 2 Music Listening * Live music played by the music therapist (e.g., guitar, voice) and AYA selected music will be used to facilitate attention to the present moment and provide cues for breathing/relaxation. 3 \& 4 Music Facilitated Breathing * The therapist will lead participants in music facilitated breathing exercises using rhythmic features of the music to cue structured breathing for relaxation and self-awareness 5 \& 6 Music Facilitated Progressive Muscle Relaxation for Stress Reduction * Using music as a structured auditory cue for tensing and releasing of muscles. 7 Body Percussion * The therapist will lead participants in a hands-on body percussion activity to bring attention to the sound of rhythm, sensation in their hands and body. 8 Participants Choice * will be selected by the participant. | Other | TiMBRe |
| ControlStandard of care study staff calls and cancer survivorship resources | Other | Attention-Control |
Primary outcome
Acceptability of TiMBRe
Time frame: up to 8 weeks post start of intervention
mean scores for the Acceptability E-scale Items are ≥ 4/5
Demand of TiMBRe
Time frame: up to 3 years from start of study
percent of patients recruited over three years
Adherence to TiMBRe
Time frame: From enrollment to end of treatment at 8 weeks
percent of TiMBRe participants to complete the baseline and 8 weeks patient report measures
Practicality of TiMBRe
Time frame: From enrollment to end of treatment at 8 weeks
percent of TiMBRe group participants self-report practicing music-based relaxation skills for at least 10 minutes on at least three days per week
2 secondary outcomes
Identification of facilitators and barriers to virtual TiMBRe participation
Time frame: up to 8 weeks post start of intervention
Change in Anxiety management
Time frame: at baseline and eight weeks post initiation of treatment
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 28 Jul 2026.
- 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 principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TiMBRe in people with Anxiety, run by University of Michigan Rogel Cancer Center 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 4 inclusion and 4 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 28 Jul 2026. 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?
Acceptability of TiMBRe (time frame: up to 8 weeks post start of intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2026.