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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: MR Therapy
* Behavioral: Relaxing Music (RM) Therapy
* Behavioral: Standard Symptom Management
* Behavioral: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are >/= 18 years of age are anticipated to undergo at least four cycles of chemotherapy treatment have had no previous treatment with chemotherapy have no evidence of distant metastatic disease can read/speak in English or Spanish have no known psychotic diagnosis have an expected survival of at least 6 months Exclusion Criteria: have a known psychotic diagnosis will undergo an undefined number of chemotherapy regimens

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MR Therapy<br>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<br>* 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.<br>Behavioral: Questionnaires<br>* Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.<br>* Other names: surveys;|
| Experimental: Relaxing Music (RM) Therapy<br>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<br>* 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<br>Behavioral: Questionnaires<br>* Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.<br>* Other names: surveys;|
| Active Comparator: Standard Symptom Management<br>Arm III: Participants receive standard symptom management education. | Behavioral: Standard Symptom Management<br>* Participants receive standard symptom management education. General information received about how to manage symptoms that develop due to the chemotherapy.<br>Behavioral: Questionnaires<br>* Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.<br>* Other names: surveys;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nausea and vomiting, unspecified adult solid tumor, protocol specific, mindfulness relaxation