AnxietyNCT03291730
A Nurse Led Project to Introduce Hand Lettering as a Form of Creative Art Expression to Patients in an Ambulatory Oncology Setting
A study testing Breathing and journaling exercise and Art-therapy in people with Anxiety, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Breathing and journaling exercise and Art-therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2018to 5 Jun 2018
- 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
- 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
Who cannot join
- -Individuals with visual impairment or blindness will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
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.
- Conditions
- Anxiety
- Being tested
- Breathing and journaling exercise, Art-therapy
- Keywords
- Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing and journaling exerciseBehavioural
May help reduce anxiety of receiving chemotherapy
Art-therapyOther
May help reduce anxiety of receiving chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Hand Lettering | Experimental | * 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. Receives: Behavioral: Breathing and journaling exercise; Other: Art-therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the feasibility of implementing nurse-led hand-lettering in an ambulatory infusion setting
Feasibility will be defined through enrollment and completion rates.
Measured: 2 years
Secondary outcomes (1)
Describe patient self-reported anxiety before and after utilizing hand-lettering
Anxiety measured through the State Trait Anxiety Index.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start9 Jan 2018
- Primary completion5 Jun 2018
- Study completion5 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cindy L. Cao, Dana-Farber Cancer Institute
- Investigators
- Cindy L Cao, RN, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291730
- Sponsor's protocol ID
- 17-377
- Status last verified
- Nov 2018
- First submitted
- 20 Sep 2017
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nurse Led Project to Introduce Hand Lettering as a Form of Creative Art Expression to Patients in an Ambulatory Oncology Setting
- ClinicalTrials.gov ID
- NCT03291730
- Acronym / sponsor ID
- 17-377
- Conditions
- Anxiety
- Keywords
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 5 Jun 2018 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hand Lettering | Experimental | Behavioral: Breathing and journaling exercise, Other: Art-therapy* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -Individuals with visual impairment or blindness will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing and journaling exerciseMay help reduce anxiety of receiving chemotherapy | Behavioural | Hand Lettering |
| Art-therapyMay help reduce anxiety of receiving chemotherapy | Other | Hand Lettering |
Primary outcome
Evaluate the feasibility of implementing nurse-led hand-lettering in an ambulatory infusion setting
Time frame: 2 years
Feasibility will be defined through enrollment and completion rates.
1 secondary outcome
Describe patient self-reported anxiety before and after utilizing hand-lettering
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy L Cao, RN principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing and journaling exercise and Art-therapy in people with Anxiety, 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 3 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 3 Dec 2018. 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?
Evaluate the feasibility of implementing nurse-led hand-lettering in an ambulatory infusion setting (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2018; AzTrials last refreshed its copy on 6 Nov 2026.