Breast CancerNCT04493034
Assessing the Benefit of Art & Music Therapy on Quality of Life in Patients With Breast Cancer
A study testing Art Therapy and Music Therapy in people with Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Art Therapy and Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2021to 22 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center
Weston, Florida, 33331
About this study
Official title: A Randomized Controlled Trial to Assess the Benefit of Art & Music Therapy on Quality of Life in Patients With Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Art Therapy, Music Therapy
- Keywords
- Cancer Survivors, Music Therapy, Art Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art TherapyBehavioural
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 TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Art Therapy | Experimental | Weekly sessions, alternating: in-person sessions (6 over 3 months), home assignments (6 over 3 months) Receives: Behavioral: Art Therapy |
| Music Therapy | Experimental | Weekly sessions, alternating: in-person sessions (6 over 3 months), home assignments (6 over 3 months) Receives: Behavioral: Music Therapy |
| Standard Of Care | No intervention | A list of support services is provided. No requirement to attend sessions and no home assignments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 180-days
Secondary outcomes (16)
Functional Assessment of Cancer Therapy - Cognition (FACT-Cog) questionnaire scores
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 guidelines
Measured: Baseline
FACT-Cog questionnaire scores
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 guidelines
Measured: At 30-days
FACT-Cog questionnaire scores
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 guidelines
Measured: At 90-days
FACT-Cog questionnaire scores
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 guidelines
Measured: At 180-days
Generalized Anxiety Disorder-7 item (GAD-7) scores
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".
Measured: Baseline
Generalized Anxiety Disorder-7 item (GAD-7) scores
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".
Measured: At 30-days
Generalized Anxiety Disorder-7 item (GAD-7) scores
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".
Measured: At 90-days
Generalized Anxiety Disorder-7 item (GAD-7) scores
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".
Measured: At 180-days
Patient Health Questionnaire-9 item (PHQ-9) scores
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
Measured: Baseline
Patient Health Questionnaire-9 item (PHQ-9) scores
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
Measured: At 30-days
Patient Health Questionnaire-9 item (PHQ-9) scores
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
Measured: At 90-days
Patient Health Questionnaire-9 item (PHQ-9) scores
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
Measured: At 180-days
Attitudes towards art/music scores
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.
Age, race/ethnicity, marital status, no. of children (if any), occupation, time since diagnosis, current chemotherapy regimen, time since therapy initiated / completed, and attitudes towards art and music will be collected as variables, to assess whether these factors are significant predictors of intervention efficacy.
Measured: Baseline
Attitudes towards art/music scores
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.
Measured: At 30-days
Attitudes towards art/music scores
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.
Measured: At 90-days
Attitudes towards art/music scores
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.
Measured: At 180-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start21 Apr 2021
- Primary completion22 Jan 2024
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeina Nahleh, MD, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493034
- Sponsor's protocol ID
- CASE5120
- Status last verified
- Dec 2024
- First submitted
- 27 Jul 2020
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share manuscripts, presentations, and abstracts
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Assess the Benefit of Art & Music Therapy on Quality of Life in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT04493034
- Acronym / sponsor ID
- CASE5120
- Conditions
- Breast Cancer
- Keywords
- Cancer Survivors, Music Therapy, Art Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Art Therapy | Experimental | Behavioral: Art TherapyWeekly sessions, alternating: in-person sessions (6 over 3 months), home assignments (6 over 3 months) |
| Music Therapy | Experimental | Behavioral: Music TherapyWeekly sessions, alternating: in-person sessions (6 over 3 months), home assignments (6 over 3 months) |
| Standard Of Care | No intervention | –A list of support services is provided. No requirement to attend sessions and no home assignments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art TherapyThe 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. | Behavioural | Art Therapy |
| Music TherapyParticipants 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. | Behavioural | Music Therapy |
Primary outcome
Functional Assessment of Cancer Therapy: Breast Cancer (FACT-B) questionnaire scores
Time frame: 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
Time frame: At 30-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.
FACT-B questionnaire scores
Time frame: At 90-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.
FACT-B questionnaire scores
Time frame: 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.
16 secondary outcomes
Functional Assessment of Cancer Therapy - Cognition (FACT-Cog) questionnaire scores
Time frame: Baseline
FACT-Cog questionnaire scores
Time frame: At 30-days
FACT-Cog questionnaire scores
Time frame: At 90-days
FACT-Cog questionnaire scores
Time frame: At 180-days
Generalized Anxiety Disorder-7 item (GAD-7) scores
Time frame: Baseline
Generalized Anxiety Disorder-7 item (GAD-7) scores
Time frame: At 30-days
Generalized Anxiety Disorder-7 item (GAD-7) scores
Time frame: At 90-days
Generalized Anxiety Disorder-7 item (GAD-7) scores
Time frame: At 180-days
Patient Health Questionnaire-9 item (PHQ-9) scores
Time frame: Baseline
Patient Health Questionnaire-9 item (PHQ-9) scores
Time frame: At 30-days
Patient Health Questionnaire-9 item (PHQ-9) scores
Time frame: At 90-days
Patient Health Questionnaire-9 item (PHQ-9) scores
Time frame: At 180-days
Attitudes towards art/music scores
Time frame: Baseline
Attitudes towards art/music scores
Time frame: At 30-days
Attitudes towards art/music scores
Time frame: At 90-days
Attitudes towards art/music scores
Time frame: At 180-days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: Yes. Will share manuscripts, presentations, and abstracts
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeina Nahleh, MD principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art Therapy and Music Therapy in people with Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy: Breast Cancer (FACT-B) questionnaire scores (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.