Comic Art Creation as Supportive Care in Cancer Patients and Caregivers

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067766
• Other study ID #: 16251
• Secondary ID: NCI-2017-0028716
• Status: Completed
• Phase: N/A
• Start date: August 24, 2017
• Est. completion date: February 8, 2019

Study information

• Verified date: May 2019
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 8, 2019
• Est. primary completion date: February 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Caregiver
• Malignant Neoplasm
• Neoplasms

Intervention

Procedure:
• Art Therapy
Participate in a comic art creation workshop

Other:
• Interview
Undergo qualitative interviews

Procedure:
• Quality-of-Life Assessment
Ancillary studies

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in anxiety and depression as measured by the Hospital Anxiety and Depression Scale questionnaire	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
Secondary	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	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