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| ID | Type | Description | Link |
|---|---|---|---|
| MDA-CCC-0106 | |||
| CDR0000357213 | Other Identifier | NCI | |
| NCI-2009-00860 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
Patients are followed annually for up to 5 years for survival.
PROJECTED ACCRUAL: A total of 474 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MR Therapy | Experimental | 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. |
|
| Relaxing Music (RM) Therapy | Experimental | 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. |
|
| Standard Symptom Management | Active Comparator | Arm III: Participants receive standard symptom management education. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR Therapy | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Hunter, MD, FRCP | Mount Sinai Hospital, Canada | Principal Investigator |
| Lorenzo Cohen, PHD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States | ||
| CCOP - Michigan Cancer Research Consortium |
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| Relaxing Music (RM) Therapy | Behavioral | 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 | Behavioral | Participants receive standard symptom management education. General information received about how to manage symptoms that develop due to the chemotherapy. |
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| Questionnaires | Behavioral | Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion. |
|
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| 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 |
| Ann Arbor |
| Michigan |
| 48106 |
| United States |
| CCOP - Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-3731 | United States |
| CCOP - Main Line Health | Wynnewood | Pennsylvania | 19096 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| University of Texas M.D. Anderson CCOP Research Base | Houston | Texas | 77030-4009 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin | 54449 | United States |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| D001943 | Breast Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004194 | Disease |
| D011471 | Prostatic Neoplasms |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D010335 | Pathologic Processes |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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