Assessing the Benefit of Art & Music Therapy on Quality of Life in Patients With Breast Cancer
NCT ID: NCT04493034
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
73 participants
INTERVENTIONAL
2021-04-21
2024-01-22
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Art Therapy
Weekly sessions, alternating: in-person sessions (6 over 3 months), home assignments (6 over 3 months)
Art Therapy
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.
Music Therapy
Weekly sessions, alternating: in-person sessions (6 over 3 months), home assignments (6 over 3 months)
Music Therapy
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.
Standard Of Care
A list of support services is provided. No requirement to attend sessions and no home assignments
No interventions assigned to this group
Interventions
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Art Therapy
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.
Music Therapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Zeina Nahleh, MD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic, Case Comprehensive Cancer Center
Locations
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Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center
Weston, Florida, United States
Countries
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Other Identifiers
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CASE5120
Identifier Type: -
Identifier Source: org_study_id