NCT03272880

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

September 25, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2018

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

7 months

First QC Date

September 1, 2017

Last Update Submit

April 24, 2018

Conditions

Keywords

Art TherapyMusic Therapy

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • Satisfaction Score

    Satisfaction will be high in post-test surveys

    Up to 8 weeks after beginning of study

Secondary Outcomes (3)

  • Qualitative Impact of arts-based programming on health

    Up to 3 weeks after final session (11 weeks from beginning of study)

  • Qualitative Impact of arts based programming on resilience

    Up to 3 weeks after final session (11 weeks from beginning of study)

  • Qualitative Impact of arts based programming on well-being

    Up to 3 weeks after final session (11 weeks from beginning of study)

Study Arms (1)

arts-based programming for cancer survivors and caregivers

EXPERIMENTAL

This is a 8-week, arts-based, health, resilience, and well-being program.

Behavioral: Arts-Based Programming

Interventions

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.

arts-based programming for cancer survivors and caregivers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe visual or auditory impairment
  • Severe and/or uncontrolled comorbidity precluding safe participation in a physical activity program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Lisa M Gallagher, MA, MT-BC

    Cleveland Clinic, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This will be a pre-post intervention observational study utilizing a mixed methods approach
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2017

First Posted

September 6, 2017

Study Start

September 25, 2017

Primary Completion

April 13, 2018

Study Completion

April 13, 2018

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations