Assessing the Benefit of Art & Music Therapy on Quality of Life in Patients With Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Art TherapyBehavioral: Music Therapy
- Registration Number
- NCT04493034
- Lead Sponsor
- Case Comprehensive Cancer Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Art Therapy Art Therapy Weekly sessions, alternating: in-person sessions (6 over 3 months), home assignments (6 over 3 months) Music Therapy Music Therapy Weekly sessions, alternating: in-person sessions (6 over 3 months), home assignments (6 over 3 months)
- Primary Outcome Measures
Name Time Method Functional Assessment of Cancer Therapy: Breast Cancer (FACT-B) questionnaire scores Baseline Quality of life (QOL) as measured by Functional Assessment of Cancer Therapy: Breast Cancer (FACT-B) questionnaire. This is a validated survey, completed by the patient, consisting of 37 items, each scored on a 0-4, Likert scale (0 = "Not at all"; 4= "Very much"). Subscales include: Physical Well-Being (PWB) (score range: 0-28), Social/Family Well-Being (SWB) (score range: 0-28), Emotional Well-Being (EWB) (score range: 0-24), Functional Well-being (FWB) (score range: 0-28), and the additional breast cancer concerns (BCS) (score range: 0-40) all with higher scores indicating better outcomes. Total scale scores range from 0 to 148 with higher scores indicating better outcomes.
FACT-B questionnaire scores At 180-days QOL as measured by FACT-B questionnaire scores. This is a validated survey, completed by the patient, consisting of 37 questions, each scored on a 0-4, Likert scale (0 = "Not at all"; 4= "Very much"). Subscales include: PWB (score range: 0-28), SWB (score range: 0-28), EWB (score range: 0-24), FWB (score range: 0-28), and BCS (score range: 0-40) all with higher scores indicating better outcomes. Total scale scores range from 0 to 148 with higher scores indicating better outcomes.
- Secondary Outcome Measures
Name Time Method Generalized Anxiety Disorder-7 item (GAD-7) scores At 180-days Self-reported anxiety as measured by GAD-7 scores. Scoring is scaled, as follows: 0 indicates "not at all", 1 indicates "several days", 2 indicates "more than half of the days", and 3 indicates "nearly every day for anxiety frequency".
FACT-Cog questionnaire scores At 180-days Cognition as measured by FACT-Cog questionnaire scores. This questionnaire contains 37 items, divided into four subscales: 1) patients' perceived cognitive impairments (score range: 0-72), 2) perceived cognitive abilities (score range: 0-28), 3) Noticeability or comments from others (score range: 0-16), and 4) impact of cognitive changes on QOL (score range: 0-16).
Higher scores indicate worse perceived cognitive deficit. FACT-Cog sub-scores are studied on their own and not included in a "total score", as advised by the scoring guidelinesPatient Health Questionnaire-9 item (PHQ-9) scores At 180-days Self-reported depression as measured by PHQ-9 scores. A score of 0-4 indicates no depression, a score of 5-9 indicates mild depression, a score of 10-14 indicates moderate depression, and a score of 15 or more indicates severe depression
Functional Assessment of Cancer Therapy - Cognition (FACT-Cog) questionnaire scores Baseline Cognition as measured by FACT-Cog questionnaire scores. This questionnaire contains 37 items, divided into four subscales: 1) patients' perceived cognitive impairments (score range: 0-72), 2) perceived cognitive abilities (score range: 0-28), 3) Noticeability or comments from others (score range: 0-16), and 4) impact of cognitive changes on QOL (score range: 0-16).
Higher scores indicate worse perceived cognitive deficit. FACT-Cog sub-scores are studied on their own and not included in a "total score", as advised by the scoring guidelinesAttitudes towards art/music scores At 180-days Intervention efficacy as measured by attitudes towards art/music, assessed in 4, 10-point Likert questions with scores ranging from 0 to 40, and higher scores indicating better attitudes.
Trial Locations
- Locations (1)
Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center
🇺🇸Weston, Florida, United States