We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comic Art Creation as Supportive Care in Cancer Patients and Caregivers

This study is currently recruiting participants.
Verified August 2017 by City of Hope Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03067766
First Posted: March 1, 2017
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
  Purpose
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.

Condition Intervention
Caregiver Malignant Neoplasm Procedure: Art Therapy Other: Interview Procedure: Quality-of-Life Assessment Other: Questionnaire Administration

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study to Test the Feasibility of Comic Art Creation for Symptom Management in Cancer Supportive Care

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.


Estimated Enrollment: 20
Anticipated Study Start Date: December 2017
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive Care (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 for approximately 45 minutes within 4 weeks prior to the workshop and midway through the workshop and complete validated questionnaires within 10 days after the end of the interview.
Procedure: Art Therapy
Participate in a comic art creation workshop
Other: Interview
Undergo qualitative interviews
Procedure: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the feasibility of using a 10 week 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 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 within 4 weeks prior to the workshop and midway through the workshop and complete validated questionnaires within 10 days after the end of the interview.

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Documented written informed consent of the participant
  • Either one of the following:

    • Cancer patient (all types and at any time point of their disease) OR
    • Caretaker/friend family member of the cancer patient
  • 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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03067766


Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Jaroslava Salman, MD    626-256-4673 ext 88741    jsalman@coh.org   
Principal Investigator: Jaroslava Salman, MD         
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jaroslava Salman, MD City of Hope Medical Center
  More Information

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT03067766     History of Changes
Other Study ID Numbers: 16251
NCI-2017-00287 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
16251 ( Other Identifier: City of Hope Medical Center )
First Submitted: February 24, 2017
First Posted: March 1, 2017
Last Update Posted: August 22, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms