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Completed

NCT Number: NCT00086762

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

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.

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Key information

Conditions

Chemotherapy-induced Nausea and Vomiting Breast Cancer Breast Diseases Breast Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Disease (or Disorder); Gynecological Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Nausea Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin and Connective Tissue Diseases Unspecified Adult Solid Tumor, Protocol Specific Urogenital Diseases Urogenital Neoplasms Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CCOP - Wichita, Wichita, Kansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • are >/= 18 years of age
  • are anticipated to undergo at least four cycles of chemotherapy treatment
  • have had no previous treatment with chemotherapy
  • have no evidence of distant metastatic disease
  • can read/speak in English or Spanish
  • have no known psychotic diagnosis
  • have an expected survival of at least 6 months

Exclusion criteria

  • have a known psychotic diagnosis
  • will undergo an undefined number of chemotherapy regimens

Treatment and study plan

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.

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.

Questionnaires

Behavioral

Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.

Other names: surveys

Primary outcomes

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

    Time frame: 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

  2. Distress as measured by Impact of Event Scale (IES)

    Time frame: 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

  3. Fatigue as measured by brief fatigue inventory (BFI)

    Time frame: 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

  4. Anxiety as measured by Spielberger State/Trait Anxiety Scale (STAI)

    Time frame: 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

  5. Depression as measured by Center for Epidemiology-Depression (CES-D)

    Time frame: 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.

  6. Sleep as measured by Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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

  7. Pain as measured by brief pain inventory (BPI)

    Time frame: 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

  8. Quality of life as measured by Functional Assessment of Cancer Therapy

    Time frame: 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 outcomes

  1. Immune suppression as measured by cytotoxicity, stimulated release of IL-12, -4, -10, intracellular cytokines and lymphocyte phenotype

    Time frame: 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

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2004
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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