Breast Cancer, Chemotherapy-induced Nausea and Vomiting, Disease (or Disorder); Gynecological, Gastrointestinal Cancer, Prostate Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
nausea and vomiting, unspecified adult solid tumor, protocol specific, mindfulness relaxation
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.
Interventions
BEHAVIORALMR 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.
BEHAVIORALRelaxing 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
BEHAVIORALStandard Symptom Management
Participants receive standard symptom management education. General information received about how to manage symptoms that develop due to the chemotherapy.
BEHAVIORALQuestionnaires
Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life as measured by Functional Assessment of Cancer Therapy | Up to 12 months post treatment | 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 |
| Conditioned nausea and vomiting as measured by Morrow assessment of nausea and emesis (MANE) | Up to 12 months post treatment | 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) | Up to 12 months post treatment | 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) | Up to 12 months post treatment | 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) | Up to 12 months post treatment | 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) | Up to 12 months post treatment | 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) | Up to 12 months post treatment | 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) | Up to 12 months post treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune suppression as measured by cytotoxicity, stimulated release of IL-12, -4, -10, intracellular cytokines and lymphocyte phenotype | Up to 12 months post treatment | 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 |
Countries
United States
Outcome results
None listed