An interventional study of Art Therapy and Interview in Caregiver and Malignant Neoplasm, sponsored by City of Hope Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-13.
Sponsored by City of Hope Medical Center · Not applicable, Interventional, and 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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 8 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
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Inclusion Criteria:
Workshop A (2017 - 10 weeks- City of Hope)
Workshops B and C (2018 - 5 weeks - City of Hope)
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 Therapy · Other: Interview · Procedure: Quality-of-Life Assessment · Other: Questionnaire Administration
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 Therapy · Other: Interview · Procedure: Quality-of-Life Assessment · Other: Questionnaire Administration
Participate in a comic art creation workshop
Undergo qualitative interviews
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
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.
Time frame: Up to 1.5 years
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.
Time frame: 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
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.
Time frame: Baseline to up to 6 weeks post-workshop
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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