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

Not Applicable

Completed

• Conditions: Breast Cancer; Chemotherapy-induced Nausea and Vomiting; Gastrointestinal Cancer; Disease (or Disorder); Gynecological; Prostate Cancer; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Behavioral: MR Therapy; Behavioral: Standard Symptom Management; Behavioral: Relaxing Music (RM) Therapy; Behavioral: Questionnaires

• Registration Number: NCT00086762
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2004-07-08
• Study First Submitted QC: 2004-07-09
• Study First Posted: 2004-07-12
• Status Verified: 2022-08
• Primary Completion: 2022-08-11
• Study Completion: 2022-08-11
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 474

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Symptom Management	Questionnaires	Arm III: Participants receive standard symptom management education.
MR Therapy	MR Therapy	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.
Standard Symptom Management	Standard Symptom Management	Arm III: Participants receive standard symptom management education.
Relaxing Music (RM) Therapy	Relaxing Music (RM) Therapy	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.
MR Therapy	Questionnaires	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	Questionnaires	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.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

CCOP - Kalamazoo; 🇺🇸 Kalamazoo, Michigan, United States

University of Texas M.D. Anderson CCOP Research Base; 🇺🇸 Houston, Texas, United States

CCOP - Marshfield Clinic Research Foundation; 🇺🇸 Marshfield, Wisconsin, United States

CCOP - Wichita; 🇺🇸 Wichita, Kansas, United States

CCOP - Michigan Cancer Research Consortium; 🇺🇸 Ann Arbor, Michigan, United States

CCOP - Greenville; 🇺🇸 Greenville, South Carolina, United States

CCOP - Grand Rapids; 🇺🇸 Grand Rapids, Michigan, United States

CCOP - Main Line Health; 🇺🇸 Wynnewood, Pennsylvania, United States

CCOP - Scott and White Hospital; 🇺🇸 Temple, Texas, United States