ClinicalTrials.gg
CompletedNCT03291730Updated Dec 3, 2018

A Nurse Led Project to Introduce Hand Lettering as a Form of Creative Art Expression to Patients in an Ambulatory Oncology Setting

An interventional study of Breathing and journaling exercise and Art-therapy in Anxiety, sponsored by Dana-Farber Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-03.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Supportive care

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Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The investigators are conducting a project to provide a new type of resource called "hand lettering" to patients receiving chemotherapy. This is a type of art therapy. The goal of this project is to understand if it is feasible to use art-therapy and to describe anxiety before and after completing hand-lettering.

Read the detailed description

This study is being done to understand if it is feasible to use a form of art-therapy called hand-lettering at Dana-Farber Cancer Institute. We would also like to explore the anxiety a person has before and after using hand-lettering.

02

Conditions studied

  • Anxiety

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Keywords

  • Anxiety
03

In context

Anxiety Disorders Unverified

7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's enrollment of 22 is below the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 834 studies on the registry; 122 are open to participants now.

Of its 114 completed or terminated interventional studies of FDA-regulated products, 78 (68%) have results posted.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients (>age 18) with a cancer diagnosis receiving oral or IV chemotherapy at Dana-Farber on Yawkey 10.
  • Able to read and speak English
  • Has a minimum appointment time of 60 minutes

Exclusion criteria

Exclusion Criteria:

-Individuals with visual impairment or blindness will be excluded

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Hand Lettering

    * The participant will engage in art-therapy by tracing and coloring a detailed letter or word * Participants will also be guided through a relaxation breathing and journaling exercise that can be incorporated into the art activity.

    Behavioral: Breathing and journaling exercise · Other: Art-therapy

Interventions

  • BehavioralBreathing and journaling exercise

    May help reduce anxiety of receiving chemotherapy

  • OtherArt-therapy

    May help reduce anxiety of receiving chemotherapy

06

What researchers measure

Primary outcomes

  1. Evaluate the feasibility of implementing nurse-led hand-lettering in an ambulatory infusion setting

    Feasibility will be defined through enrollment and completion rates.

    Time frame: 2 years

Secondary outcomes

  1. Describe patient self-reported anxiety before and after utilizing hand-lettering

    Anxiety measured through the State Trait Anxiety Index.

    Time frame: 2 years

07

Study locations

1 site
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02115, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Jun 2018, 4 months.

Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 4 months is below that.

Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2017
First posted
Sep 25, 2017
StartActual
Jan 9, 2018
Primary completionActual
Jun 5, 2018
CompletionActual
Jun 5, 2018
Last update
Dec 3, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03291730
Responsible party
Cindy L. Cao (Principal Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted
Sep 25, 2017
Start date
Jan 9, 2018
Primary completion
Jun 5, 2018
Completion
Jun 5, 2018
Last update
Dec 3, 2018

Study contacts

Cindy L Cao, RN
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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