AWARENESS Trial (AWARENESS) of Storytelling Through Music in Healthcare Workers
An Arts-based Intervention With Healthcare Workers: Storytelling Through Music to Address Work Related Emotions (AWARENESS Trial)
1 other identifier
interventional
24
1 country
1
Brief Summary
This research study is examining the feasibility and effectiveness of an online version of the Storytelling Through Music (STM) program with oncology nurses who have worked during the COVID-19 pandemic.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
1 active site
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
February 24, 2021
CompletedFirst Posted
Study publicly available on registry
March 1, 2021
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedNovember 19, 2024
November 1, 2024
3.5 years
February 24, 2021
November 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility of intervention
Primary endpoint is feasibility using visual analog scale Descriptive statistics will be used on the visual analog scale questions for analysis of feasibility. This intervention will be deemed feasible if 85% of the intervention is completed and 60% find it acceptable.
6 weeks
Acceptability of intervention
Additional primary endpoint is acceptability using descriptive qualitative data. Open-ended questions will prompt participants to provide insights into quantitative findings and the acceptability of the intervention. This intervention will be deemed feasible if 85% of the intervention is completed and 60% find it acceptable.
6 weeks
Secondary Outcomes (9)
Self-awareness
6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
Post-traumatic stress
6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
Self-compassion
6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
Anxiety
6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
Depression
6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
- +4 more secondary outcomes
Study Arms (2)
Storytelling Through Music (STM)
EXPERIMENTALParticipants will be randomized into two (2) groups: Storytelling Through Music (STM) and Waitlist (Storytelling Through Music-Hybrid) Storytelling Through Music (STM) group will participate in the study for a total of 19 weeks with 6 weeks of the STM program and 3 months follow up. * Storytelling Through Music (STM) utilizes multiple modalities including storytelling, reflective writing, self-care skills (i.e., breathing exercises, meditation, self-compassion, body scans), and songwriting. * Weeks 1-4: participants are led through weekly writing workshop over an online platform (i.e., Zoom or an equivalent) to develop their stories. Simultaneous with the writing sessions are 10-minute self-care lessons * Week 5: Participants will be paired with a professional songwriter who will put their story into a song. * Week 6: During the last week, participants will have one more writing workshop to debrief about the intervention.
Wait List / Storytelling Through Music-Hybrid
EXPERIMENTALParticipants will be randomized into two (2) groups: Storytelling Through Music (STM) and Waitlist (Storytelling Through Music-Hybrid) Waitlist control group (Storytelling Through Music-Hybrid) will participate in the study for a total of 13 weeks with 2 weeks of Storytelling Through Music-Hybrid program and 11 weeks of follow up . * Storytelling Through Music-Hybrid involves participants listening to songs created for other healthcare professionals for 2 weeks.
Interventions
6 week expressive arts-based program
2 week song listening program
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Related Publications (1)
Phillips CS, Morris SE, Woods H, Mazzola E, Xiong N, Young C, Stuifbergen A, Hammer M, Ligibel J. A Randomized Controlled Feasibility Study to Evaluate the Online Delivery of Storytelling Through Music With Oncology Nurses. Cancer Nurs. 2024 Dec 19. doi: 10.1097/NCC.0000000000001441. Online ahead of print.
PMID: 39701577DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carolyn Phillips, PhD, RN
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 24, 2021
First Posted
March 1, 2021
Study Start
March 1, 2021
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
November 19, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.