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Utilizing the Arts to Improve Health, Resilience, and Well-Being Among Cancer Patients and Their Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03272880
Recruitment Status : Completed
First Posted : September 6, 2017
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Arts-Based Programming Not Applicable

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:

  1. Recruitment
  2. Participation
  3. Retention (drop-outs)
  4. Satisfaction

Secondary:

To assess the participants' ability to:

  1. Define goals and strategies using the contents of the program.
  2. Implement the strategies in their daily activities in the short-term.
  3. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This will be a pre-post intervention observational study utilizing a mixed methods approach
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Utilizing the Arts to Improve Health, Resilience, and Well-Being in Individuals With Cancer and Their Caregivers: A Feasibility Study
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : April 13, 2018
Actual Study Completion Date : April 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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.
Behavioral: Arts-Based Programming
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Satisfaction Score [ Time Frame: Up to 8 weeks after beginning of study ]
    Satisfaction will be high in post-test surveys


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272880


Locations
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United States, Ohio
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Lisa M Gallagher, MA, MT-BC Cleveland Clinic, Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03272880    
Other Study ID Numbers: CASE14Z17
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Case Comprehensive Cancer Center:
Art Therapy
Music Therapy