Clinical trial NCT00086762: Mindfulness Relaxation Compared With Relaxing Music and Standard Symptom Management Education in Treating Patients Who Are Undergoing Chemotherapy For Newly Diagnosed Solid Tumors
Official title: Chemotherapy and Mindfulness Relaxation: A Randomized Trial at M.D. Anderson Cancer Center and M.D. Anderson Community Clinical Oncology Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-induced Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific
Breast Cancer
Gastrointestinal Cancer
Disease (or Disorder); Gynecological
Prostate Cancer
Keywords: nausea and vomiting
unspecified adult solid tumor, protocol specific
mindfulness relaxation
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-07-12
Enrollment: 474
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Conditioned nausea and vomiting as measured by Morrow assessment of nausea and emesis (MANE)
timeFrame: Up to 12 months post treatment
measure: Distress as measured by Impact of Event Scale (IES)
timeFrame: Up to 12 months post treatment
measure: Fatigue as measured by brief fatigue inventory (BFI)
timeFrame: Up to 12 months post treatment
measure: Anxiety as measured by Spielberger State/Trait Anxiety Scale (STAI)
timeFrame: Up to 12 months post treatment
measure: Depression as measured by Center for Epidemiology-Depression (CES-D)
timeFrame: Up to 12 months post treatment
measure: Sleep as measured by Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Up to 12 months post treatment
measure: Pain as measured by brief pain inventory (BPI)
timeFrame: Up to 12 months post treatment
measure: Quality of life as measured by Functional Assessment of Cancer Therapy
timeFrame: Up to 12 months post treatment
Secondary outcomes:
measure: Immune suppression as measured by cytotoxicity, stimulated release of IL-12, -4, -10, intracellular cytokines and lymphocyte phenotype
timeFrame: Up to 12 months post treatment
Other outcomes:
Locations:
city: Wichita
country: United States
facility: CCOP - Wichita
state: Kansas
city: Ann Arbor
country: United States
facility: CCOP - Michigan Cancer Research Consortium
state: Michigan
city: Grand Rapids
country: United States
facility: CCOP - Grand Rapids
state: Michigan
city: Kalamazoo
country: United States
facility: CCOP - Kalamazoo
state: Michigan
city: Wynnewood
country: United States
facility: CCOP - Main Line Health
state: Pennsylvania
city: Greenville
country: United States
facility: CCOP - Greenville
state: South Carolina
city: Houston
country: United States
facility: University of Texas M.D. Anderson CCOP Research Base
state: Texas
city: Temple
country: United States
facility: CCOP - Scott and White Hospital
state: Texas
city: Marshfield
country: United States
facility: CCOP - Marshfield Clinic Research Foundation
state: Wisconsin
Study officials:
affiliation: Mount Sinai Hospital, Canada
name: Jon Hunter, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: M.D. Anderson Cancer Center
name: Lorenzo Cohen, PHD
role: STUDY_CHAIR
References: