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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Chemotherapy-induced Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific, Breast Cancer, Gastrointestinal Cancer, Disease (or Disorder); Gynecological, Prostate Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Conditioned nausea and vomiting as measured by Morrow assessment of nausea and emesis (MANE)

Outcome Description:

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

Outcome Time Frame:

Up to 12 months post treatment

Safety Issue:

No

Principal Investigator

Jon Hunter, MD, FRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai Hospital, Toronto

Authority:

United States: Institutional Review Board

Study ID:

2004-0024

NCT ID:

NCT00086762

Start Date:

June 2004

Completion Date:

Related Keywords:

  • Chemotherapy-Induced Nausea and Vomiting
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Breast Cancer
  • Gastrointestinal Cancer
  • Disease (or Disorder); Gynecological
  • Prostate Cancer
  • nausea and vomiting
  • unspecified adult solid tumor, protocol specific
  • mindfulness relaxation
  • Breast Neoplasms
  • Disease
  • Nausea
  • Prostatic Neoplasms
  • Vomiting
  • Gastrointestinal Neoplasms

Name

Location

CCOP - WichitaWichita, Kansas  67214-3882
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
CCOP - GreenvilleGreenville, South Carolina  29615
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Scott and White HospitalTemple, Texas  76508
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
CCOP - Main Line HealthWynnewood, Pennsylvania  19096
University of Texas M.D. Anderson CCOP Research BaseHouston, Texas  77030-4009