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OpenTrials
Completed

NCT Number: NCT03067766

Comic Art Creation as Supportive Care in Cancer Patients and Caregivers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Art Therapy

Procedure

Participate in a comic art creation workshop

interview

Other

Undergo qualitative interviews

quality-of-life assessment

Procedure

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 1, 2017
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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