Clinical trial NCT04493034: Assessing the Benefit of Art & Music Therapy on Quality of Life in Patients With Breast Cancer
Official title: A Randomized Controlled Trial to Assess the Benefit of Art & Music Therapy on Quality of Life in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Cancer Survivors
Music Therapy
Art Therapy
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a study of art-based and music-based therapy programs lasting three months (with additional follow-up 3 months after the end of the trial) in breast cancer patients currently receiving therapy as well as in cancer survivors.

Detailed description: A cancer diagnosis is often associated with adverse psychosocial effects, including: increased stress and anxiety, fatigue and sleep disturbance, impaired memory and cognition, and poor quality of life. Chemotherapy can cause a cognitive decline in up to 75% of patients; an impairment that oftentimes persists beyond completion of the regimen. This is known as "chemobrain". Integrative therapies are actively being investigated to help improve psychological wellbeing among cancer patients and survivors.

The current standard at this institution is to inform patients of different complementary services that are available, including art therapy, music therapy or acupuncture, but not require patients to use them.

Participants in this study will be randomized to one of three arms 1) Art therapy program, 2) Music therapy program, or 3) Standard of care (SOC). In-person and at-home therapy sessions will be scheduled in alternating, weekly sessions, to allow one week of self-reflection and remote therapy between in-person sessions. Each participant will be asked to attend two in-person therapy sessions per month (total of 6).

The primary objective of this study is 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.

Secondary objectives of this study are:

To determine the effect of these programs on patient cognition in this population.

To determine the effect of these programs symptoms of anxiety and depression in this population.

To assess whether the effect of these programs is sustained at a 3-month follow-up.

Eligibility criteria: Inclusion Criteria:

* Breast cancer diagnosis (stage 0-III)
* 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.
* Able and willing to participate in art or music therapy programs at Maroone Cancer Center
* Subjects must have the ability to understand and the willingness to sign a written informed consent document
* Ability to read and write in English
* Performance status 0 or 1 as per ECOG scale

Exclusion Criteria:

* No prior history of breast cancer
* History of metastatic disease (Stage IV)
* Not being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Cleveland Clinic
* Unable or unwilling to participate in art or music therapy program at Maroone Cancer Center

Primary outcomes:
measure: Functional Assessment of Cancer Therapy: Breast Cancer (FACT-B) questionnaire scores
timeFrame: Baseline
measure: FACT-B questionnaire scores
timeFrame: At 30-days
measure: FACT-B questionnaire scores
timeFrame: At 90-days
measure: FACT-B questionnaire scores
timeFrame: At 180-days
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy - Cognition (FACT-Cog) questionnaire scores
timeFrame: Baseline
measure: FACT-Cog questionnaire scores
timeFrame: At 30-days
measure: FACT-Cog questionnaire scores
timeFrame: At 90-days
measure: FACT-Cog questionnaire scores
timeFrame: At 180-days
measure: Generalized Anxiety Disorder-7 item (GAD-7) scores
timeFrame: Baseline
measure: Generalized Anxiety Disorder-7 item (GAD-7) scores
timeFrame: At 30-days
measure: Generalized Anxiety Disorder-7 item (GAD-7) scores
timeFrame: At 90-days
measure: Generalized Anxiety Disorder-7 item (GAD-7) scores
timeFrame: At 180-days
measure: Patient Health Questionnaire-9 item (PHQ-9) scores
timeFrame: Baseline
measure: Patient Health Questionnaire-9 item (PHQ-9) scores
timeFrame: At 30-days
measure: Patient Health Questionnaire-9 item (PHQ-9) scores
timeFrame: At 90-days
measure: Patient Health Questionnaire-9 item (PHQ-9) scores
timeFrame: At 180-days
measure: Attitudes towards art/music scores
timeFrame: Baseline
measure: Attitudes towards art/music scores
timeFrame: At 30-days
measure: Attitudes towards art/music scores
timeFrame: At 90-days
measure: Attitudes towards art/music scores
timeFrame: At 180-days
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center
state: Florida
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: Zeina Nahleh, MD
role: PRINCIPAL_INVESTIGATOR
References: