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临床试验/NCT03067766
NCT03067766已完成不适用

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

City of Hope Medical Center2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2017年8月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
2
主要终点
Feasibility of the comic art creation workshop defined as participant completion and psychosocial value of the comic art

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 未提供

研究组 & 干预措施

Workshop A (10 weeks - comic art creation workshop)

Experimental

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.

干预措施: Art Therapy (Procedure)

Workshop A (10 weeks - comic art creation workshop)

Experimental

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.

干预措施: Interview (Other)

Workshop A (10 weeks - comic art creation workshop)

Experimental

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.

干预措施: Quality-of-Life Assessment (Procedure)

Workshop A (10 weeks - comic art creation workshop)

Experimental

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.

干预措施: Questionnaire Administration (Other)

Workshop B and C (5 weeks - comic art creation workshop)

Experimental

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.

干预措施: Art Therapy (Procedure)

Workshop B and C (5 weeks - comic art creation workshop)

Experimental

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.

干预措施: Interview (Other)

Workshop B and C (5 weeks - comic art creation workshop)

Experimental

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.

干预措施: Quality-of-Life Assessment (Procedure)

Workshop B and C (5 weeks - comic art creation workshop)

Experimental

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.

干预措施: Questionnaire Administration (Other)

结局指标

主要结局

Feasibility of the comic art creation workshop defined as participant completion and psychosocial value of the comic art

时间窗: 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.

次要结局

  • Change in anxiety and depression as measured by the Hospital Anxiety and Depression Scale questionnaire(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(Baseline to up to 6 weeks post-workshop)

研究者

发起方
City of Hope Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (2)

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