This clinical trial studies a therapist-led art or music therapy program in improving quality of life in patients with stage 0-III breast cancer. A cancer diagnosis can be a stressful experience. Many patients report dealing with anxiety, fatigue, sleep disturbances, and memory or concentration problems. The art-based and/or music-based therapy program may help patients with breast cancer achieve an improved quality of life.
Additional locations may be listed on ClinicalTrials.gov for NCT04493034.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. 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:
I. To determine the effect of these programs on patient cognition in this population.
II. To determine the effect of these programs on symptoms of anxiety and depression in this population.
III. To assess whether the effect of these programs is sustained at a 3-month follow-up.
IV. 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.
V. To understand if there is a statistically significant association between scoring on validated surveys for psychological wellbeing (Functional Assessment of Cancer Therapy-Breast [FACT-B], Generalized Anxiety Disorder - 7 [GAD-7], Patient Health Questionnaire - 9 [PHQ-9], FACT-Cognitive Function [Cog]) and a 4-component wellness visual analog scale constructed and used previously at the Cleveland Clinic.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I (ART THERAPY PROGRAM): Patients attend two therapist-led art therapy sessions (1 individual session and 5 group sessions) over 60 minutes each, every month for up to 6 sessions. Each session involves a new therapeutic prompt or bridge from prior session, creative expression, opportunity for reflection, verbal sharing / processing, and a session summary, and discussion of action plan for the next consecutive, at-home session.
ARM II (MUSIC THERAPY PROGRAM): Patients attend two therapist-led music therapy sessions (1 individual session and 5 group sessions) over 60 minutes each, every month for up to 6 sessions. During these sessions, six psychological goals are promoted: self-care/self-love, support systems, practicing positivity gratitude, mindfulness/living in the moment, and goal setting.
ARM III (STANDARD OF CARE): Patients receive education on the availability of multiple complementary holistic therapies, including but not limited to art therapy, music therapy, acupuncture, book club, massage therapy, Reiki, nutrition counseling services, yoga, and survivorship brunch.
After the completion of study intervention, patients are followed up for 3 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorZeina Ahmad Nahleh