Trial record 1 of 1 for:    CHEMOTHERAPY AND MINDFULNESS RELAXATION: A RANDOMIZED TRIAL AT M. D. ANDERSON CANCER CENTER AND M. D. ANDERSON COMMUNITY CLINICAL ONCOLOGY PROGRAM
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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

July 8, 2004
September 23, 2013
June 2004
June 2015   (final data collection date for primary outcome measure)
  • 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
Not Provided
Complete list of historical versions of study NCT00086762 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
Mindfulness Relaxation Compared With Relaxing Music and Standard Symptom Management Education in Treating Patients Who Are Undergoing Chemotherapy For Newly Diagnosed Solid Tumors
Chemotherapy and Mindfulness Relaxation: A Randomized Trial at M.D. Anderson Cancer Center and M.D. Anderson Community Clinical Oncology Program

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Chemotherapy-induced Nausea and Vomiting
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Breast Cancer
  • Gastrointestinal Cancer
  • Disease (or Disorder); Gynecological
  • Prostate Cancer
  • 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: 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: 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
  • 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.
    Interventions:
    • Behavioral: MR Therapy
    • Behavioral: Questionnaires
  • 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.
    Interventions:
    • Behavioral: Relaxing Music (RM) Therapy
    • Behavioral: Questionnaires
  • Active Comparator: Standard Symptom Management
    Arm III: Participants receive standard symptom management education.
    Interventions:
    • Behavioral: Standard Symptom Management
    • Behavioral: Questionnaires
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
474
Not Provided
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00086762
2004-0024, MDA-CCC-0106, CDR0000357213
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Jon Hunter, MD, FRCP Mount Sinai Hospital, Toronto
M.D. Anderson Cancer Center
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP