- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03272880
Utilizing the Arts to Improve Health, Resilience, and Well-Being Among Cancer Patients and Their Caregivers
April 24, 2018 updated by: Case Comprehensive Cancer Center
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic, Case Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Severe visual or auditory impairment
- Severe and/or uncontrolled comorbidity precluding safe participation in a physical activity program
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: arts-based programming for cancer survivors and caregivers
This is a 8-week, arts-based, health, resilience, and well-being program.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Up to 8 weeks after beginning of study
|
|
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
|
Up to 8 weeks after beginning of study
|
|
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
|
Up to 8 weeks after beginning of study
|
|
Satisfaction Score
Time Frame: Up to 8 weeks after beginning of study
|
Satisfaction will be high in post-test surveys
|
Up to 8 weeks after beginning of study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative Impact of arts-based programming on health
Time Frame: Up to 3 weeks after final session (11 weeks from beginning of study)
|
Impact of program on health described in phenomenological interviews
|
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)
|
Impact of program on resilience described in phenomenological interviews
|
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)
|
Impact of program on well-being described in phenomenological interviews
|
Up to 3 weeks after final session (11 weeks from beginning of study)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lisa M Gallagher, MA, MT-BC, Cleveland Clinic, Case Comprehensive Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 25, 2017
Primary Completion (Actual)
April 13, 2018
Study Completion (Actual)
April 13, 2018
Study Registration Dates
First Submitted
September 1, 2017
First Submitted That Met QC Criteria
September 1, 2017
First Posted (Actual)
September 6, 2017
Study Record Updates
Last Update Posted (Actual)
April 26, 2018
Last Update Submitted That Met QC Criteria
April 24, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CASE14Z17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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