Back to resultsFeasibility of Virtual, Tailored, Music-Based Relaxation for Anxiety in Adolescent and Young Adult Cancer Survivors
Primary Purpose
Anxiety
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TiMBRe
Control
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TiMBRe
Attention-Control
Arm Description
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.
Standard of care study staff calls and cancer survivorship resources
Outcomes
Primary Outcome Measures
Acceptability of TiMBRe
mean scores for the Acceptability E-scale Items are ≥ 4/5
Demand of TiMBRe
percent of patients recruited over three years
Adherence to TiMBRe
percent of TiMBRe participants to complete the baseline and 8 weeks patient report measures
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
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05911269
First Posted
June 12, 2023
Last Updated
August 30, 2023
Sponsor
University of Michigan Rogel Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05911269
Brief Title
Feasibility of Virtual, Tailored, Music-Based Relaxation for Anxiety in Adolescent and Young Adult Cancer Survivors
Official Title
Determining the Feasibility of Virtual, Tailored, Music-Based Relaxation for Anxiety in Adolescent and Young Adult Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
February 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Explanatory-Sequential Mixed Methods Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TiMBRe
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention-Control
Arm Type
Active Comparator
Arm Description
Standard of care study staff calls and cancer survivorship resources
Intervention Type
Other
Intervention Name(s)
TiMBRe
Intervention Description
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 & 8 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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Standard of care study staff calls and cancer survivorship resources
Primary Outcome Measure Information:
Title
Acceptability of TiMBRe
Description
mean scores for the Acceptability E-scale Items are ≥ 4/5
Time Frame
up to 8 weeks post start of intervention
Title
Demand of TiMBRe
Description
percent of patients recruited over three years
Time Frame
up to 3 years from start of study
Title
Adherence to TiMBRe
Description
percent of TiMBRe participants to complete the baseline and 8 weeks patient report measures
Time Frame
From enrollment to end of treatment at 8 weeks
Title
Practicality of TiMBRe
Description
percent of TiMBRe group participants self-report practicing music-based relaxation skills for at least 10 minutes on at least three days per week
Time Frame
From enrollment to end of treatment at 8 weeks
Secondary Outcome Measure Information:
Title
Identification of facilitators and barriers to virtual TiMBRe participation
Description
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.
Time Frame
up to 8 weeks post start of intervention
Title
Change in Anxiety management
Description
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.
Time Frame
at baseline and eight weeks post initiation of treatment
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:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Knoerl
Phone
734-764-8617
Email
rjknoerl@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Knoerl
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Knoerl
Phone
734-764-8617
Email
rjknoerl@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Robert Knoerl
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility of Virtual, Tailored, Music-Based Relaxation for Anxiety in Adolescent and Young Adult Cancer Survivors
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