Clinical trial NCT03067766: Comic Art Creation as Supportive Care in Cancer Patients and Caregivers
Official title: A Pilot Study to Test the Feasibility of Comic Art Creation for Symptom Management in Cancer Supportive Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver
Malignant Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-03-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility of the comic art creation workshop defined as participant completion and psychosocial value of the comic art
timeFrame: Up to 1.5 years
Secondary outcomes:
measure: Change in anxiety and depression as measured by the Hospital Anxiety and Depression Scale questionnaire
timeFrame: Baseline to up to 6 weeks post-workshop
measure: 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
timeFrame: Baseline to up to 6 weeks post-workshop
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Jaroslava Salman, MD
role: PRINCIPAL_INVESTIGATOR
References: