AWARENESS Trial (AWARENESS) of Storytelling Through Music in Healthcare Workers

Not Applicable

Completed

• Conditions: Stress; Post Traumatic Stress Disorder; Work Related Stress

• Registration Number: NCT04775524
• Lead Sponsor: Dana-Farber Cancer Institute

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.

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 Timeline

• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-02-25
• Study Start: 2021-03-01
• Study First Posted: 2021-03-01
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of intervention	6 weeks	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.
Acceptability of intervention	6 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States