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)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stress; Post Traumatic Stress Disorder; Work Related Stress
• Intervention / Treatment: Behavioral: Storytelling Through Music (STM); Behavioral: Wait List / Storytelling Through Music-Hybrid

Detailed Description

This study employs a two-group, randomized controlled trial design that will utilize quantitative and qualitative methods to evaluate the feasibility and intervention effect of an alternative delivery (online) of the Storytelling Through Music program (STM).

Previous study of In-person delivery of Storytelling Through Music program STM with oncology nurses found it to be feasible and beneficial to coping with stress and work-related emotions.

The research study procedures include: screening for eligibility and study intervention including follow-up surveys.

Participants will be randomized into two (2) groups: Storytelling Through Music (STM) and Waitlist (Storytelling Through Music-Hybrid)

STM group: Participants are led through a writing workshop over an online platform (i.e., Zoom or an equivalent) to develop their story. Simultaneous with the writing sessions are 10-minute self-care lessons. At the end of the development workshop, each participant will be paired with a songwriter who will turn participant stories into songs. A final workshop will be held for participants to debrief about the emotional experience of participating in the Storytelling Through Music program (STM)

Waitlist control group (Storytelling Through Music-Hybrid), will listen to songs created by healthcare workers in the Storytelling Through Music program (STM) for 2 weeks.

Participation length will be based on the randomized group assignment, a total of 19 weeks for the STM group and 13 weeks for the waitlist group.

It is expected that about 50 people will take part in this research study.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The inclusion criteria for the study is as follows: a) >18 years old; b) licensed oncology nurse; c) provided direct patient care during COVID-19 pandemic.

Exclusion Criteria:

• Key exclusion criteria include: a) have previously participated in the STM intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Storytelling Through Music (STM); Participants 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 lessonsWeek 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.	Behavioral: Storytelling Through Music (STM); 6 week expressive arts-based program
Experimental: Wait List / Storytelling Through Music-Hybrid; Participants 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.	Behavioral: Wait List / Storytelling Through Music-Hybrid; 2 week song listening program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-awareness	Self-Reflection and Insight Scale; range is 12-72; higher score means better outcome.	6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
Post-traumatic stress	Impact of Event Scale-Revised; range is 0-88; lower score is better outcome.	6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
Self-compassion	Self-Compassion Scale; range is 26-130; higher score is better outcome.	6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
Anxiety	PROMIS Anxiety Scale (Short-form 6); range is 5-30; lower score is better outcome.	6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
Depression	PROMIS Depression Scale (Short-form 8); range is 8-40; lower score is better outcome.	6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
Insomnia	Insomnia Severity Index; range is 0-28; lower score is better outcome	6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
Loneliness	UCLA Loneliness Scale; range is 0-60; lower score is better outcome.	6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
Post-traumatic growth	Post-Traumatic Growth Index; range is 0-105; lower score is better outcome.	6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
Professional Quality of Life	Professional Quality of Life Scale; 3 separate subscale scores=burnout (range is 10-50; lower score equals better outcome); Secondary traumatic stress (range is 10-50; lower score equals better outcome); Compassion satisfaction (range is 10-50; higher score equals better outcome).	6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Carolyn Phillips, PhD, RN, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Stress; Post Traumatic Stress Disorder; Work Related Stress
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Stress, Psychological; Occupational Diseases; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Occupational Stress
• Other Study ID Numbers: 20-710

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No