CancerNCT03272880
Utilizing the Arts to Improve Health, Resilience, and Well-Being Among Cancer Patients and Their Caregivers
A study testing Arts-Based Programming in people with Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of arts-based programming on health, well-being, and resilience. Patients who have cancer or are the caregivers of someone with cancer are being asked to take part in this study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Arts-Based Programming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2017to 13 Apr 2018
- 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
- Able to participate in all program sessions
- Cognitively able to consent to participate
- Speaks, reads, and writes English
- Diagnosis of cancer or caregiver of someone with cancer
Who cannot join
- Severe visual or auditory impairment
- Severe and/or uncontrolled comorbidity precluding safe participation in a physical activity program
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Utilizing the Arts to Improve Health, Resilience, and Well-Being in Individuals With Cancer and Their Caregivers: A Feasibility Study
The purpose of this study is to evaluate the impact of arts-based programming on health, well-being, and resilience. Patients who have cancer or are the caregivers of someone with cancer are being asked to take part in this study.
Read the detailed description
Objective:
Primary:
To assess the feasibility and acceptability of arts-based programming for community-dwelling cancer survivors and caregivers. Feasibility and acceptability will be assessed based on:
- Recruitment
- Participation
- Retention (drop-outs)
- Satisfaction
Secondary:
To assess the participants' ability to:
- Define goals and strategies using the contents of the program.
- Implement the strategies in their daily activities in the short-term.
- Continue to use these strategies after the program ends.
Exploratory:
To perform exploratory analyses on the impact of arts-based programming on health, resilience, and well-being.
- Conditions
- Cancer
- Being tested
- Arts-Based Programming
- Keywords
- Art Therapy, Music Therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arts-Based ProgrammingBehavioural
This feasibility study includes educational components and an experiential components which are assessed with pre- and post-tests. The topics of these components include: Introduction to the Arts and Health; Music, Well-Being, and Resilience; Movement and Physical Activity; Art and Well-Being; Theater and Socialization; Art Appreciation and a Healthy Brain; and Summary/Integration of the Arts into Daily Lives. The impact of this program will be assessed with qualitative follow-up interviews.
| Study group | Role | What they receive |
|---|---|---|
| arts-based programming for cancer survivors and caregivers | Experimental | This is a 8-week, arts-based, health, resilience, and well-being program. Receives: Behavioral: Arts-Based Programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Number of participants recruited in the study
Study will be feasible if recruitment goal is met with 10-20 participants enrolled
Measured: Up to 8 weeks after beginning of study
Feasibility: Average number of session attended by participants
Study will be feasible if average number of session attended will be greater than or equal to 4
Measured: Up to 8 weeks after beginning of study
Percent of patients who drop out of study
Study will be feasible if no more than 25% of patients drop out of study
Measured: Up to 8 weeks after beginning of study
Satisfaction Score
Satisfaction will be high in post-test surveys
Measured: Up to 8 weeks after beginning of study
Secondary outcomes (3)
Qualitative Impact of arts-based programming on health
Impact of program on health described in phenomenological interviews
Measured: Up to 3 weeks after final session (11 weeks from beginning of study)
Qualitative Impact of arts based programming on resilience
Impact of program on resilience described in phenomenological interviews
Measured: Up to 3 weeks after final session (11 weeks from beginning of study)
Qualitative Impact of arts based programming on well-being
Impact of program on well-being described in phenomenological interviews
Measured: Up to 3 weeks after final session (11 weeks from beginning of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start25 Sep 2017
- Primary completion13 Apr 2018
- Study completion13 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer 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
- Not applicable
- Intervention model
- Single group
- Model description
- This will be a pre-post intervention observational study utilizing a mixed methods approach
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa M Gallagher, MA, MT-BC, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272880
- Sponsor's protocol ID
- CASE14Z17
- Status last verified
- Apr 2018
- First submitted
- 1 Sep 2017
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing the Arts to Improve Health, Resilience, and Well-Being in Individuals With Cancer and Their Caregivers: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03272880
- Acronym / sponsor ID
- CASE14Z17
- Conditions
- Cancer
- Keywords
- Art Therapy, Music Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 13 Apr 2018 (actual)
- First posted
- 6 Sep 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.
The purpose of this study is to evaluate the impact of arts-based programming on health, well-being, and resilience. Patients who have cancer or are the caregivers of someone with cancer are being asked to take part in this study.
Detailed description
Objective:
Primary:
To assess the feasibility and acceptability of arts-based programming for community-dwelling cancer survivors and caregivers. Feasibility and acceptability will be assessed based on:
- Recruitment
- Participation
- Retention (drop-outs)
- Satisfaction
Secondary:
To assess the participants' ability to:
- Define goals and strategies using the contents of the program.
- Implement the strategies in their daily activities in the short-term.
- Continue to use these strategies after the program ends.
Exploratory:
To perform exploratory analyses on the impact of arts-based programming on health, resilience, and well-being.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a pre-post intervention observational study utilizing a mixed methods approach
| Arm | Type | Receives |
|---|---|---|
| arts-based programming for cancer survivors and caregivers | Experimental | Behavioral: Arts-Based ProgrammingThis is a 8-week, arts-based, health, resilience, and well-being program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to participate in all program sessions
- Cognitively able to consent to participate
- Speaks, reads, and writes English
- Diagnosis of cancer or caregiver of someone with cancer
Key exclusion criteria (2 listed)
- Severe visual or auditory impairment
- Severe and/or uncontrolled comorbidity precluding safe participation in a physical activity program
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 |
|---|---|---|
| Arts-Based ProgrammingThis feasibility study includes educational components and an experiential components which are assessed with pre- and post-tests. The topics of these components include: Introduction to the Arts and Health; Music, Well-Being, and Resilience; Movement and Physical Activity; Art and Well-Being; Theater and Socialization; Art Appreciation and a Healthy Brain; and Summary/Integration of the Arts into Daily Lives. The impact of this program will be assessed with qualitative follow-up interviews. | Behavioural | arts-based programming for cancer survivors and caregivers |
Primary outcome
Feasibility: Number of participants recruited in the study
Time frame: Up to 8 weeks after beginning of study
Study will be feasible if recruitment goal is met with 10-20 participants enrolled
Feasibility: Average number of session attended by participants
Time frame: Up to 8 weeks after beginning of study
Study will be feasible if average number of session attended will be greater than or equal to 4
Percent of patients who drop out of study
Time frame: Up to 8 weeks after beginning of study
Study will be feasible if no more than 25% of patients drop out of study
Satisfaction Score
Time frame: Up to 8 weeks after beginning of study
Satisfaction will be high in post-test surveys
3 secondary outcomes
Qualitative Impact of arts-based programming on health
Time frame: Up to 3 weeks after final session (11 weeks from beginning of study)
Qualitative Impact of arts based programming on resilience
Time frame: Up to 3 weeks after final session (11 weeks from beginning of study)
Qualitative Impact of arts based programming on well-being
Time frame: Up to 3 weeks after final session (11 weeks from beginning of study)
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 26 Apr 2018.
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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.
Lisa M Gallagher, MA, MT-BC principal investigator
Cleveland Clinic, Case Comprehensive Cancer 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 Arts-Based Programming in people with Cancer, run by Case Comprehensive Cancer 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 4 inclusion and 2 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 26 Apr 2018. 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: Number of participants recruited in the study (time frame: Up to 8 weeks after beginning of study). The study lists 4 primary outcomes in all. 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 26 Apr 2018; AzTrials last refreshed its copy on 7 Nov 2026.