Clinical trial NCT03272880: Utilizing the Arts to Improve Health, Resilience, and Well-Being Among Cancer Patients and Their Caregivers
Official title: Utilizing the Arts to Improve Health, Resilience, and Well-Being in Individuals With Cancer and Their Caregivers: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Art Therapy
Music Therapy
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This will be a pre-post intervention observational study utilizing a mixed methods approach
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Feasibility: Number of participants recruited in the study
timeFrame: Up to 8 weeks after beginning of study
measure: Feasibility: Average number of session attended by participants
timeFrame: Up to 8 weeks after beginning of study
measure: Percent of patients who drop out of study
timeFrame: Up to 8 weeks after beginning of study
measure: Satisfaction Score
timeFrame: Up to 8 weeks after beginning of study
Secondary outcomes:
measure: Qualitative Impact of arts-based programming on health
timeFrame: Up to 3 weeks after final session (11 weeks from beginning of study)
measure: Qualitative Impact of arts based programming on resilience
timeFrame: Up to 3 weeks after final session (11 weeks from beginning of study)
measure: Qualitative Impact of arts based programming on well-being
timeFrame: Up to 3 weeks after final session (11 weeks from beginning of study)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: Lisa M Gallagher, MA, MT-BC
role: PRINCIPAL_INVESTIGATOR
References: