Comic Art Creation as Supportive Care in Cancer Patients and Caregivers

May 9, 2019 updated by: City of Hope Medical Center

A Pilot Study to Test the Feasibility of Comic Art Creation for Symptom Management in Cancer Supportive Care

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the feasibility of using a 10 week (Workshop A) or a 5 week (Workshops B-C) comic art creation workshops for supportive care.

II. To determine the feasibility of studying comic art creation workshops for supportive care.

III. To describe those factors affecting the ability or inability of participants to engage in the workshop.

SECONDARY OBJECTIVES:

I. To describe changes in emotional wellbeing and communication of patients and caretakers/family/friends.

TERTIARY OBJECTIVES:

I. Identify the methods that most engage supportive care patients and caretakers.

II. Identify the social and cultural interactions most impacted by comics creation.

III. To describe participant feedback regarding the intervention and study design.

OUTLINE: Patients are assigned to 1 of 2 arms.

WORKSHOP A: 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.

WORKSHOPS B AND C: 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.

After completion of the study, patients are followed up at 1 and 6 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Workshop A (10 weeks - comic art creation workshop)
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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Procedure: Art Therapy
Participate in a comic art creation workshop
Other: Interview
Undergo qualitative interviews
Experimental: Workshop B and C (5 weeks - comic art creation workshop)
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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Procedure: Art Therapy
Participate in a comic art creation workshop
Other: Interview
Undergo qualitative interviews

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of the comic art creation workshop defined as participant completion and psychosocial value of the comic art
Time Frame: Up to 1.5 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in anxiety and depression as measured by the Hospital Anxiety and Depression Scale questionnaire
Time Frame: Baseline to up to 6 weeks post-workshop
Statistical analysis will include Wilcoxon signed ranks test of pre, mid and post workshop HRQOL and symptom assessments. The Friedman test will be used to measure magnitude of difference within a case.
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
Time Frame: Baseline to up to 6 weeks post-workshop
Statistical analysis will include Wilcoxon signed ranks test of pre, mid and post workshop HRQOL and symptom assessments. The Friedman test will be used to measure magnitude of difference within a case.
Baseline to up to 6 weeks post-workshop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
City of Hope Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jaroslava Salman, MD, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 8, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16251 (Other Identifier: City of Hope Medical Center)
  • NCI-2017-00287 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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