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

M.D. Anderson Cancer Center

Status: Completed

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

Treatments: Behavioral: Standard Symptom Management; Behavioral: Relaxing Music (RM) Therapy; Behavioral: Questionnaires; Behavioral: MR Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00086762

2004-0024

NCI-2009-00860 (Registry Identifier)

CDR0000357213 (Other Identifier)

MDA-CCC-0106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 474 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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474 participants in 3 patient groups

MR Therapy

Experimental group

Description:

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.

Treatment:

Behavioral: MR Therapy

Behavioral: Questionnaires

Relaxing Music (RM) Therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Relaxing Music (RM) Therapy

Behavioral: Questionnaires

Standard Symptom Management

Active Comparator group

Description:

Arm III: Participants receive standard symptom management education.

Treatment:

Behavioral: Standard Symptom Management

Behavioral: Questionnaires