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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00231408 | Other Identifier | University of Michigan | |
| R34CA286712 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Attention-Control | Active Comparator | Standard of care study staff calls and cancer survivorship resources |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TiMBRe | Other | 1 & 2 Music Listening
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| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of TiMBRe | mean scores for the Acceptability E-scale Items are ≥ 4/5 | up to 8 weeks post start of intervention |
| Demand of TiMBRe | percent of patients recruited over three years | 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 | 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 | From enrollment to end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Knoerl | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48118 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000083002 | Timbre Perception |
| ID | Term |
|---|---|
| D001307 | Auditory Perception |
| D000084323 | Vestibulocochlear Physiological Phenomena |
| D010829 | Physiological Phenomena |
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Explanatory-Sequential Mixed Methods Study
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| Control | Other | Standard of care study staff calls and cancer survivorship resources |
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| 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. | at baseline and eight weeks post initiation of treatment |