Assessing the Benefit of Art & Music Therapy on Quality of Life in Patients With Breast Cancer

NCT04493034 | Completed

• 1 other identifier: CASE5120
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Cancer Survivors; Music Therapy; Art Therapy

Outcome Measures

Primary Outcomes (4)

• Functional Assessment of Cancer Therapy: Breast Cancer (FACT-B) questionnaire scores

  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.

  Baseline

• FACT-B questionnaire scores

  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.

  At 30-days

• FACT-B questionnaire scores

  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.

  At 90-days

• FACT-B questionnaire scores

  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.

  At 180-days

Secondary Outcomes (16)

• Functional Assessment of Cancer Therapy - Cognition (FACT-Cog) questionnaire scores

  Baseline

• FACT-Cog questionnaire scores

  At 30-days

• FACT-Cog questionnaire scores

  At 90-days

• FACT-Cog questionnaire scores

  At 180-days

• Generalized Anxiety Disorder-7 item (GAD-7) scores

  Baseline

Study Arms (3)

Art Therapy

EXPERIMENTAL

Weekly sessions, alternating: in-person sessions (6 over 3 months), home assignments (6 over 3 months)

Behavioral: Art Therapy

Music Therapy

EXPERIMENTAL

Weekly sessions, alternating: in-person sessions (6 over 3 months), home assignments (6 over 3 months)

Behavioral: Music Therapy

Standard Of Care

NO INTERVENTION

A list of support services is provided. No requirement to attend sessions and no home assignments

Interventions

Art Therapy BEHAVIORAL

The art therapist will assist each participant in producing a bound collection of participant art works/writings for personal, group and/or caregiver inspiration, at the participant's request. For in-person sessions, a variety of studio-based art and writing materials will be available for participant selection and creation. Each session will be directed in the following manner: * New therapeutic prompt or bridge from prior session * Creative expression, opportunity for reflection, verbal sharing / processing, and a session summary * Discussion of action plan for the next consecutive, at-home session (weekly assignment). Possible wellness themes for each session (in-person or at-home) may include: mental health, physical health, emotional health, spiritual health, relational health (family and social), or occupational health/financial health.

Art Therapy

Music Therapy BEHAVIORAL

Participants have the opportunity to engage in: learning an instrument, active music-making, receptive music-listening, singing, improvisation, song-writing, education on music technology, or music discussion. During in-person musical sessions the six psychosocial goals promoted by the music therapist include: 1) self-care/self-love, 2) support systems, 3) practicing positivity 4) gratitude 5) mindfulness/living in the moment, and 6) goal-setting. For at-home assignments, participants will be asked to pick a song of the week that coincides with the theme/goal discussed in previous session(s). They will be asked to write a journal entry about the topic discussed. Journal entries can be freely written or a prompt/question can be provided. If participants do not have access to search for songs or listen to music as at home, they may select a piece from the session and be given lyrics and/or a recording on an .mp3 player returned at conclusion of study.

Music Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Art Therapy; Music Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Zeina Nahleh, MD

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 30, 2020
• Study Start: April 21, 2021
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)