NCT03067766

Brief Summary

This pilot clinical trial studies how well comic art creation works as supportive care in cancer patients and caregivers. Participating in a comic art creation workshop may help patients and their family members or friends share their medical experience through storytelling and drawings in a way that can, but does not have to, reflect the real world. It may also help improve emotional wellbeing and communication in cancer patients and caregivers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

August 24, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2019

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

1.5 years

First QC Date

February 24, 2017

Last Update Submit

May 9, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the comic art creation workshop defined as participant completion and psychosocial value of the comic art

    The project will be considered feasible if most of the participants complete the study and consider the comic art to have personal meaning, and if an initial power calculation indicates that a sufficiently powered randomized controlled trial is possible given the resources of the study team. It is anticipated that the psychosocial value of the art will be largely derived from the internal creation process and further assessment of the artistic products will not be conducted.

    Up to 1.5 years

Secondary Outcomes (2)

  • Change in anxiety and depression as measured by the Hospital Anxiety and Depression Scale questionnaire

    Baseline to up to 6 weeks post-workshop

  • Change in health-related quality of life (HRQOL) as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30

    Baseline to up to 6 weeks post-workshop

Study Arms (2)

Workshop A (10 weeks - comic art creation workshop)

EXPERIMENTAL

Patients and a family member, caretaker, or friend participate in an artist-led comic art therapy workshop over 2 hours once a week for 10 weeks. Patients and participants receive a range of assignments that focus on creative art and experimentation with materials and storytelling in order to make a series of small handmade books that relate directly or indirectly to their experience with cancer. Patients undergo a qualitative interview over approximately 45 minutes and complete validated questionnaires within 4 weeks prior to the workshop and midway through the workshop.

Procedure: Art TherapyOther: InterviewProcedure: Quality-of-Life AssessmentOther: Questionnaire Administration

Workshop B and C (5 weeks - comic art creation workshop)

EXPERIMENTAL

Patients participate in an artist-led comic art therapy workshop over 3 hours once a week for 5 weeks. Patients receive a range of assignments that focus on creative art and experimentation with materials and storytelling in order to make a series of small handmade books that relate directly or indirectly to their experience with cancer. Patients undergo a qualitative interview over approximately 45 minutes and complete validated questionnaires within 4 weeks prior to the workshop.

Procedure: Art TherapyOther: InterviewProcedure: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Art TherapyPROCEDURE

Participate in a comic art creation workshop

Workshop A (10 weeks - comic art creation workshop)Workshop B and C (5 weeks - comic art creation workshop)

Undergo qualitative interviews

Workshop A (10 weeks - comic art creation workshop)Workshop B and C (5 weeks - comic art creation workshop)

Ancillary studies

Also known as: Quality of Life Assessment
Workshop A (10 weeks - comic art creation workshop)Workshop B and C (5 weeks - comic art creation workshop)

Ancillary studies

Workshop A (10 weeks - comic art creation workshop)Workshop B and C (5 weeks - comic art creation workshop)

Eligibility Criteria

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

You may qualify if:

  • Documented written informed consent of the participant
  • Workshop A (2017 - 10 weeks- City of Hope)
  • Either one of the following:
  • City of Hope (COH) cancer patient (all types and at any time point of their disease) OR
  • Caretaker/friend family member of the cancer patient
  • Workshops B and C (2018 - 5 weeks - City of Hope)
  • Cancer patients (all types and at any time point in their disease)
  • Note: documentation to confirm this eligibility criteria will not be requested; self-reporting as a cancer patient will be considered adequate
  • Ability read and speak English
  • Willingness and ability to complete the entire workshop, including the interviews and questionnaires (there is no predetermined qualification with regard to the ability to hold an artist tool; accommodations and creative solutions will be made to facilitate participation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Art TherapyInterviews as Topic

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jaroslava Salman, MD

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2017

First Posted

March 1, 2017

Study Start

August 24, 2017

Primary Completion

February 8, 2019

Study Completion

February 8, 2019

Last Updated

May 13, 2019

Record last verified: 2019-05

Locations