IRB Study Number FLA20-055
Status Recruiting
Location Cleveland Clinic Florida
Institute Taussig Cancer Institute
Description
Primary objective
To determine the efficacy of a 3-month, therapist-led art or music therapy program to improve quality of life in breast cancer patients currently receiving therapy and in cancer survivors.
Other objectives
1 To determine the effect of these programs on patient cognition in this population.
2 To determine the effect of these programs on symptoms of anxiety and depression in this population.
3 To assess whether the effect of these programs is sustained at a 3-month follow-up.
4 To understand if there are differences in response to these programs based on demographic and clinical characteristics, as well as pre-trial attitudes towards art and music.
5 To understand if there is a statistically significant association between scoring on validated surveys for psychological wellbeing (FACT-B, GAD-7, PHQ-9, FACT-Cog) and a 4-component wellness visual analog scale constructed and used previously at the Cleveland Clinic.
Inclusion Criteria
1 Age: 18 years and older.
2 Breast cancer diagnosis (stage 0-III)
3 Treated at Cleveland Clinic by medical oncologist, radiation oncologist, and/or breast surgeon Patients currently undergoing treatment or have completed active treatment (surgery, radiation or chemotherapy) within past 5 years.
4 Able and willing to participate in art or music therapy programs at Maroone Cancer Center
5 Subjects must have the ability to understand and the willingness to sign a written informed consent document
6 Ability to read and write in English
7 Performance status 0 or 1 as per ECOG scale [Appendix I]
8 For participants who will be attending virtually, they must have video conferencing capacities, as hardware will not be provided by the Cleveland Clinic
Exclusion Criteria
1 Under 18 years of age
2 No prior history of breast cancer
3 History of metastatic disease (Stage IV)
4 Not being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Cleveland Clinic
5 Unable or unwilling to participate in art or music therapy program at Maroone Cancer Center
6 Patients enrolled onto other trials at the Maroone Cancer Center also investigating wellness programs and patient quality of life.
