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

Breast Cancer Clinical Trial

Official title:

A Randomized Controlled Trial to Assess the Benefit of Art & Music Therapy on Quality of Life in Patients With Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04493034
• Other study ID #: CASE5120
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: January 2024
• Source: Case Comprehensive Cancer Center
• Contact: Zeina Nahleh, MD
• Phone: +1 954-659-5840
• Email: NAHLEHZ[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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	Baseline
Secondary	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	At 30-days
Secondary	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	At 90-days
Secondary	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	At 180-days
Secondary	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".	Baseline
Secondary	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".	At 30-days
Secondary	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".	At 90-days
Secondary	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".	At 180-days
Secondary	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	Baseline
Secondary	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	At 30-days
Secondary	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	At 90-days
Secondary	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	At 180-days
Secondary	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.	Baseline
Secondary	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.	At 30-days
Secondary	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.	At 90-days
Secondary	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.	At 180-days