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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03272880
Other study ID # CASE14Z17
Secondary ID
Status Completed
Phase N/A
First received September 1, 2017
Last updated April 24, 2018
Start date September 25, 2017
Est. completion date April 13, 2018

Study information

Verified date April 2018
Source Case Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date April 13, 2018
Est. primary completion date April 13, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Cleveland Clinic, Case Comprehensive Cancer Center Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility: Number of participants recruited in the study Study will be feasible if recruitment goal is met with 10-20 participants enrolled Up to 8 weeks after beginning of study
Primary 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 Up to 8 weeks after beginning of study
Primary Percent of patients who drop out 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
Primary Satisfaction Score Satisfaction will be high in post-test surveys Up to 8 weeks after beginning of study
Secondary Qualitative Impact of arts-based programming on health Impact of program on health described in phenomenological interviews Up to 3 weeks after final session (11 weeks from beginning of study)
Secondary Qualitative Impact of arts based programming on resilience Impact of program on resilience described in phenomenological interviews Up to 3 weeks after final session (11 weeks from beginning of study)
Secondary Qualitative Impact of arts based programming on well-being Impact of program on well-being described in phenomenological interviews Up to 3 weeks after final session (11 weeks from beginning of study)
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