CaregiverNCT03067766
Comic Art Creation as Supportive Care in Cancer Patients and Caregivers
A study testing Art Therapy, Interview and Quality-of-Life Assessment in people with Caregiver and Malignant Neoplasm, run by City of Hope Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver, Malignant Neoplasm
- What is being tested?
- Art Therapy, Interview and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2017to 8 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: A Pilot Study to Test the Feasibility of Comic Art Creation for Symptom Management in Cancer 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- To describe changes in emotional wellbeing and communication of patients and caretakers/family/friends.
TERTIARY OBJECTIVES:
- 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.
- Conditions
- Caregiver, Malignant Neoplasm
- Being tested
- Art Therapy, Interview, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art TherapyProcedure or surgery
Participate in a comic art creation workshop
InterviewOther
Undergo qualitative interviews
Quality-of-Life AssessmentProcedure or surgery
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Art Therapy; Other: Interview; Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration |
| 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. Receives: Procedure: Art Therapy; Other: Interview; Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1.5 years
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline to up to 6 weeks post-workshop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start24 Aug 2017
- Primary completion8 Feb 2019
- Study completion8 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiverStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jaroslava Salman, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067766
- Sponsor's protocol ID
- 16251
- Other IDs
- NCI-2017-00287, 16251
- Status last verified
- May 2019
- First submitted
- 24 Feb 2017
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Test the Feasibility of Comic Art Creation for Symptom Management in Cancer Supportive Care
- ClinicalTrials.gov ID
- NCT03067766
- Acronym / sponsor ID
- 16251
- Conditions
- Caregiver, Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 8 Feb 2019 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- To describe changes in emotional wellbeing and communication of patients and caretakers/family/friends.
TERTIARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Workshop A (10 weeks - comic art creation workshop) | Experimental | Procedure: Art Therapy, Other: Interview, Procedure: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
| Workshop B and C (5 weeks - comic art creation workshop) | Experimental | Procedure: Art Therapy, Other: Interview, Procedure: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Documented written informed consent of the participant
- Workshop A (2017 - 10 weeks- City of Hope)
- Workshops B and C (2018 - 5 weeks - City of Hope)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art TherapyParticipate in a comic art creation workshop | Procedure or surgery | Workshop A (10 weeks - comic art creation workshop), Workshop B and C (5 weeks - comic art creation workshop) |
| InterviewUndergo qualitative interviews | Other | Workshop A (10 weeks - comic art creation workshop), Workshop B and C (5 weeks - comic art creation workshop) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Procedure or surgery | Workshop A (10 weeks - comic art creation workshop), Workshop B and C (5 weeks - comic art creation workshop) |
| Questionnaire AdministrationAncillary studies | Other | Workshop A (10 weeks - comic art creation workshop), Workshop B and C (5 weeks - comic art creation workshop) |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaroslava Salman, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art Therapy, Interview and Quality-of-Life Assessment in people with Caregiver and Malignant Neoplasm, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.