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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00086762
First received: July 8, 2004
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Chemotherapy-induced Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific
Breast Cancer
Gastrointestinal Cancer
Disease (or Disorder); Gynecological
Prostate Cancer
Behavioral: MR Therapy
Behavioral: Relaxing Music (RM) Therapy
Behavioral: Standard Symptom Management
Behavioral: Questionnaires

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Chemotherapy and Mindfulness Relaxation: A Randomized Trial at M.D. Anderson Cancer Center and M.D. Anderson Community Clinical Oncology Program

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Conditioned nausea and vomiting as measured by Morrow assessment of nausea and emesis (MANE) [ Time Frame: Up to 12 months post treatment ] [ Designated as safety issue: No ]
    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

  • Distress as measured by Impact of Event Scale (IES) [ Time Frame: Up to 12 months post treatment ] [ Designated as safety issue: No ]
    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

  • Fatigue as measured by brief fatigue inventory (BFI) [ Time Frame: Up to 12 months post treatment ] [ Designated as safety issue: No ]
    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

  • Anxiety as measured by Spielberger State/Trait Anxiety Scale (STAI) [ Time Frame: Up to 12 months post treatment ] [ Designated as safety issue: No ]
    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

  • Depression as measured by Center for Epidemiology-Depression (CES-D) [ Time Frame: Up to 12 months post treatment ] [ Designated as safety issue: No ]
    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.

  • Sleep as measured by Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Up to 12 months post treatment ] [ Designated as safety issue: No ]
    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

  • Pain as measured by brief pain inventory (BPI) [ Time Frame: Up to 12 months post treatment ] [ Designated as safety issue: No ]
    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

  • Quality of life as measured by Functional Assessment of Cancer Therapy [ Time Frame: Up to 12 months post treatment ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Immune suppression as measured by cytotoxicity, stimulated release of IL-12, -4, -10, intracellular cytokines and lymphocyte phenotype [ Time Frame: Up to 12 months post treatment ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 474
Study Start Date: June 2004
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MR Therapy
Participants receive Mindfulness Relaxation (MR) therapy as in the pilot phase. A CD with the mindfulness relaxation technique recorded on it will be given to participant. Participant to listen to the recording for about 30 minutes before receiving chemotherapy and during the time they are receiving chemotherapy. In addition to the mindfulness relaxation technique, they will also receive general information about how to manage symptoms that develop due to the chemotherapy they are receiving.
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.
Behavioral: Questionnaires
Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.
Other Name: surveys
Experimental: Relaxing Music (RM) Therapy
Arm II: 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.
Behavioral: 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
Behavioral: Questionnaires
Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.
Other Name: surveys
Active Comparator: Standard Symptom Management
Arm III: Participants receive standard symptom management education.
Behavioral: Standard Symptom Management
Participants receive standard symptom management education. General information received about how to manage symptoms that develop due to the chemotherapy.
Behavioral: Questionnaires
Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.
Other Name: surveys

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed malignant solid tumor
  • Undergoing at least 4 courses of chemotherapy
  • No evidence of distant metastatic disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • At least 6 months

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Able to read and speak English or Spanish
  • No known psychotic diagnosis

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • No prior chemotherapy
  • Not planning to undergo an undefined number of chemotherapy regimens

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086762

Locations
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Pennsylvania
CCOP - Main Line Health
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, Texas
University of Texas M.D. Anderson CCOP Research Base
Houston, Texas, United States, 77030-4009
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Jon Hunter, MD, FRCP Mount Sinai Hospital, Toronto
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00086762     History of Changes
Other Study ID Numbers: 2004-0024, MDA-CCC-0106, CDR0000357213
Study First Received: July 8, 2004
Last Updated: September 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
nausea and vomiting
unspecified adult solid tumor, protocol specific
mindfulness relaxation

Additional relevant MeSH terms:
Breast Neoplasms
Disease
Nausea
Prostatic Neoplasms
Vomiting
Gastrointestinal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on April 15, 2014