NCT03291730

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 9, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2018

Completed
Last Updated

December 3, 2018

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

September 20, 2017

Last Update Submit

November 29, 2018

Conditions

Anxiety

Keywords

Anxiety

Outcome Measures

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.

    2 years

Secondary Outcomes (1)

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

    2 years

Study Arms (1)

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.

Behavioral: Breathing and journaling exerciseOther: Art-therapy

Interventions

Breathing and journaling exerciseBEHAVIORAL

May help reduce anxiety of receiving chemotherapy

Hand Lettering
Art-therapyOTHER

May help reduce anxiety of receiving chemotherapy

Hand Lettering

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Individuals with visual impairment or blindness will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

RespirationArt Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaSensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Cindy L Cao, RN

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 25, 2017

Study Start

January 9, 2018

Primary Completion

June 5, 2018

Study Completion

June 5, 2018

Last Updated

December 3, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)