Mindfulness Relaxation Compared With Relaxing Music and Standard Symptom Management Education in Treating Patients Who Are Undergoing Chemotherapy For Newly Diagnosed Solid Tumors

Breast Cancer Clinical Trial

Official title:

Chemotherapy and Mindfulness Relaxation: A Randomized Trial at M.D. Anderson Cancer Center and M.D. Anderson Community Clinical Oncology Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00086762
• Other study ID #: 2004-0024
• Secondary ID: MDA-CCC-0106CDR0
• Status: Completed
• Phase: N/A
• Start date: June 2004
• Est. completion date: August 11, 2022

Study information

• Verified date: August 2022
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 3/10/2012.)

• 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 3/10/2012.)

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 474
• Est. completion date: August 11, 2022
• Est. primary completion date: August 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. are >/= 18 years of age

2. are anticipated to undergo at least four cycles of chemotherapy treatment

3. have had no previous treatment with chemotherapy

4. have no evidence of distant metastatic disease

5. can read/speak in English or Spanish

6. have no known psychotic diagnosis

7. have an expected survival of at least 6 months

Exclusion Criteria:

1. have a known psychotic diagnosis

2. will undergo an undefined number of chemotherapy regimens

Related Conditions & MeSH terms

• Breast Cancer
• Chemotherapy-induced Nausea and Vomiting
• Disease
• Disease (or Disorder); Gynecological
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Nausea
• Prostate Cancer
• Unspecified Adult Solid Tumor, Protocol Specific
• Vomiting

Intervention

Behavioral:
• MR Therapy
Arm I: Participants receive Mindfulness Relaxation (MR) therapy as in the pilot phase. Instructions given on breathing techniques and other practices to help relax mind and body.
• Relaxing Music (RM) Therapy
Participants 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
• Standard Symptom Management
Participants receive standard symptom management education. General information received about how to manage symptoms that develop due to the chemotherapy.
• Questionnaires
Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.

Locations

Country	Name	City	State
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	CCOP - Greenville	Greenville	South Carolina
United States	University of Texas M.D. Anderson CCOP Research Base	Houston	Texas
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	CCOP - Wichita	Wichita	Kansas
United States	CCOP - Main Line Health	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conditioned nausea and vomiting as measured by Morrow assessment of nausea and emesis (MANE)	Number of incidents conditioned nausea and vomiting as measured by MANE at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment	Up to 12 months post treatment
Primary	Distress as measured by Impact of Event Scale (IES)	Distress as measured by Impact of Event Scale (IES) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment	Up to 12 months post treatment
Primary	Fatigue as measured by brief fatigue inventory (BFI)	Fatigue as measured by brief fatigue inventory (BFI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment	Up to 12 months post treatment
Primary	Anxiety as measured by Spielberger State/Trait Anxiety Scale (STAI)	Anxiety as measured by Spielberger State/Trait Anxiety Scale (STAI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment	Up to 12 months post treatment
Primary	Depression as measured by Center for Epidemiology-Depression (CES-D)	Depression as measured by Center for Epidemiology-Depression (CES-D) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment.	Up to 12 months post treatment
Primary	Sleep as measured by Pittsburgh Sleep Quality Index (PSQI)	Sleep as measured by Pittsburgh Sleep Quality Index (PSQI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment	Up to 12 months post treatment
Primary	Pain as measured by brief pain inventory (BPI)	Pain as measured by brief pain inventory (BPI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment	Up to 12 months post treatment
Primary	Quality of life as measured by Functional Assessment of Cancer Therapy	Quality of life as measured by Functional Assessment of Cancer Therapy at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment	Up to 12 months post treatment
Secondary	Immune suppression as measured by cytotoxicity, stimulated release of IL-12, -4, -10, intracellular cytokines and lymphocyte phenotype	Immune suppression as measured by cytotoxicity, stimulated release of IL-12, -4, -10, intracellular cytokines and lymphocyte phenotype at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment	Up to 12 months post treatment