Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-01-04 @ 8:00 PM
Study NCT ID:
NCT04493034
Status:
COMPLETED
Last Update Posted:
2024-12-18
First Post:
2020-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Benefit of Art & Music Therapy on Quality of Life in Patients With Breast Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial to Assess the Benefit of Art & Music Therapy on Quality of Life in Patients With Breast Cancer
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: