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StressNCT04775524

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

A study testing Storytelling Through Music (STM) and Wait List / Storytelling Through Music-Hybrid in people with Stress and Post Traumatic Stress Disorder, run by Dana-Farber Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Storytelling Through Music (STM) and Wait List / Storytelling Through Music-Hybrid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
1 Mar 2021to 31 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Storytelling Through Music (STM), Wait List / Storytelling Through Music-Hybrid
Keywords
Stress, Post Traumatic Stress Disorder, Work Related Stress
Medical subject headings
Stress Disorders, Post-Traumatic, Occupational Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Storytelling Through Music (STM)Behavioural

    6 week expressive arts-based program

  • Wait List / Storytelling Through Music-HybridBehavioural

    2 week song listening program

Study groups in NCT04775524
Study groupRoleWhat they receive
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.
Receives: Behavioral: Storytelling Through Music (STM)
Wait List / Storytelling Through Music-HybridExperimentalParticipants 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.
Receives: Behavioral: Wait List / Storytelling Through Music-Hybrid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

Secondary outcomes (9)

  1. Self-awareness

    Self-Reflection and Insight Scale; range is 12-72; higher score means better outcome.

    Measured: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)

  2. Post-traumatic stress

    Impact of Event Scale-Revised; range is 0-88; lower score is better outcome.

    Measured: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)

  3. Self-compassion

    Self-Compassion Scale; range is 26-130; higher score is better outcome.

    Measured: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)

  4. Anxiety

    PROMIS Anxiety Scale (Short-form 6); range is 5-30; lower score is better outcome.

    Measured: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)

  5. Depression

    PROMIS Depression Scale (Short-form 8); range is 8-40; lower score is better outcome.

    Measured: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)

  6. Insomnia

    Insomnia Severity Index; range is 0-28; lower score is better outcome

    Measured: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)

  7. Loneliness

    UCLA Loneliness Scale; range is 0-60; lower score is better outcome.

    Measured: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)

  8. Post-traumatic growth

    Post-Traumatic Growth Index; range is 0-105; lower score is better outcome.

    Measured: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)

  9. 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).

    Measured: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2021
  2. Study start1 Mar 2021
  3. Primary completion31 Aug 2024
  4. Study completion31 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04775524
Sponsor's protocol ID
20-710
Status last verified
Nov 2024
First submitted
24 Feb 2021
Last updated
19 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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. 2026 Jul-Aug 01;49(4):290-301. doi: 10.1097/NCC.0000000000001441. Epub 2024 Dec 20.

    PubMed 39701577

Questions about this trial

What is this clinical trial studying?

A study testing Storytelling Through Music (STM) and Wait List / Storytelling Through Music-Hybrid in people with Stress and Post Traumatic Stress Disorder, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of intervention (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04775524, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.

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