Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086762
Status:
COMPLETED
Last Update Posted:
2022-09-01
First Post:
2004-07-08
Brief Title:
Mindfulness Relaxation Compared With Relaxing Music and Standard Symptom Management Education in Treating Patients Who Are Undergoing Chemotherapy For Newly Diagnosed Solid Tumors
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Chemotherapy and Mindfulness Relaxation A Randomized Trial at MD Anderson Cancer Center and MD Anderson Community Clinical Oncology Program
Status:
COMPLETED
Status Verified Date:
2022-08
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:
RATIONALE Mindfulness relaxation a technique to help patients quiet their thoughts and relax their bodies before and during chemotherapy may reduce or prevent nausea and vomiting It may also help improve mental health quality of life and immune function in patients receiving chemotherapy
PURPOSE This randomized clinical trial is studying mindfulness relaxation to see how well it works compared to relaxing music or standard symptom management education in treating patients who are receiving chemotherapy for newly diagnosed solid tumors
PURPOSE This randomized clinical trial is studying mindfulness relaxation to see how well it works compared to relaxing music or standard symptom management education in treating patients who are receiving chemotherapy for newly diagnosed solid tumors
Detailed Description:
OBJECTIVES
Primary
Compare the effect of mindfulness relaxation vs relaxing music vs standard symptom management education on conditioned and nonconditioned nausea and vomiting in patients with newly diagnosed solid tumors undergoing chemotherapy
Secondary
Compare mental health anxiety depression and distress quality of life cancer-related symptoms fatigue sleep and pain and immune function in patients receiving these interventions
OUTLINE This is a multicenter study comprising a pilot phase followed by a randomized phase Pilot phase completed as of 3102012
Pilot phase Patients undergo mindfulness relaxation MR therapy comprising listening to instructions on breathing techniques and other mind and body relaxation practices on compact disc for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment Pilot phase completed as of 3102012
Randomized phase Patients are randomized to 1 of 3 treatment arms
Arm I Patients undergo MR therapy as in the pilot phase
Arm II Patients listen to relaxing music with no instructions on relaxation techniques for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment
Arm III Patients receive standard symptom management education In both phases nausea and vomiting mental health anxiety depression and distress and quality of life cancer-related symptoms fatigue sleep and pain are assessed at baseline periodically during treatment and then at 3 months
Patients are followed annually for up to 5 years for survival
PROJECTED ACCRUAL A total of 474 patients will be accrued for this study
Primary
Compare the effect of mindfulness relaxation vs relaxing music vs standard symptom management education on conditioned and nonconditioned nausea and vomiting in patients with newly diagnosed solid tumors undergoing chemotherapy
Secondary
Compare mental health anxiety depression and distress quality of life cancer-related symptoms fatigue sleep and pain and immune function in patients receiving these interventions
OUTLINE This is a multicenter study comprising a pilot phase followed by a randomized phase Pilot phase completed as of 3102012
Pilot phase Patients undergo mindfulness relaxation MR therapy comprising listening to instructions on breathing techniques and other mind and body relaxation practices on compact disc for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment Pilot phase completed as of 3102012
Randomized phase Patients are randomized to 1 of 3 treatment arms
Arm I Patients undergo MR therapy as in the pilot phase
Arm II Patients listen to relaxing music with no instructions on relaxation techniques for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment
Arm III Patients receive standard symptom management education In both phases nausea and vomiting mental health anxiety depression and distress and quality of life cancer-related symptoms fatigue sleep and pain are assessed at baseline periodically during treatment and then at 3 months
Patients are followed annually for up to 5 years for survival
PROJECTED ACCRUAL A total of 474 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MDA-CCC-0106 | None | None | None |
| CDR0000357213 | OTHER | None | None |
| NCI-2009-00860 | REGISTRY | NCI CTRP | None |