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NCT Number: NCT00253708

Massage Therapy in Treating the Symptoms of Patients With Locally Advanced or Metastatic Cancer

RATIONALE: Massage therapy may help relieve symptoms associated with cancer. It is not yet known which type of massage therapy is more effective in treating the symptoms of patients with cancer.

PURPOSE: This randomized clinical trial is studying different types of massage therapy to compare how well they work in treating the symptoms of patients with locally advanced or metastatic cancer.

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Key information

Conditions

Cancer Adenocarcinoma Adnexal Diseases Behavior Behavioral Symptoms Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Carcinoma, Ovarian Epithelial Carcinoma, Renal Cell Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Depression Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Nausea Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Neurologic Manifestations Nevi and Melanomas Ovarian Diseases Ovarian Neoplasms Pain Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Small Cell Lung Carcinoma Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Vomiting

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

OBJECTIVES:

  • Compare the safety and tolerated dose (i.e., duration, techniques, and degree of pressure) of professional massage therapy vs professional simple presence (no touch) massage therapy vs usual care followed by caregiver massage therapy vs usual care in patients with locally advanced or metastatic cancer.
  • Correlate these therapies with pain, anxiety, depression, nausea, and shortness of breath in these patients.
  • Correlate these therapies with patient quality of life and caregiver anxiety and depression.
  • Determine the feasibility of teaching family caregivers how to provide massage therapy and the subsequent use of massage by the caregivers.
  • Determine the effects of caregiver massage therapy on patients and caregivers.
  • Determine the feasibility and acceptability among patients and massage therapists of a simple presence (no touch) massage therapy control group.

OUTLINE: This is a randomized, controlled, pilot study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I (professional massage therapy): Hospitalized patients are offered massage therapy by a licensed massage therapist for 15-45 minutes once daily for the duration of their hospital stay. Outpatient oncology clinic patients are offered home-based massage therapy by a licensed massage therapist for 15-45 minutes once daily for 3 days.
  • Arm II (usual care): Patients receive usual care for symptom management.
  • Arm III (professional simple presence [no touch] massage therapy): Hospitalized patients are offered simple presence (no touch) massage therapy comprising a room visit by a licensed massage therapist who places his/her hands 12 inches over the patient without direct touch for 15-45 minutes. Treatment is offered once daily for the duration of the hospital stay. Outpatient oncology clinic patients are offered home-based simple presence (no touch) massage therapy by a licensed massage therapist for 15-45 minutes once daily for 3 days.

All patients are then randomized (a second time) to 1 of 2 treatment arms.

  • Arm I (caregiver massage therapy): Previously hospitalized patients are offered home-based caregiver massage therapy for 1 month. Outpatient oncology clinic patients are offered home-based caregiver massage therapy for 3 weeks.
  • Arm II (usual care): Patients receive usual care for symptom management. Hospitalized patients complete a questionnaire addressing symptoms, quality of life, satisfaction with symptom control, and time spent up or out of bed once daily on days 1-5, every 3 days while in the hospital, and then at 1 week, 2 weeks, and 1 month after discharge from the hospital. Outpatient oncology clinic patients complete a similar telephone questionnaire at baseline, 1 week, and then at 1 month.

PROJECTED ACCRUAL: Approximately 100 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

  • Solid cancer with evidence of metastases
  • Receiving treatment at Beth Israel Deaconess Medical Center (BIDMC)
  • Must reside ≤ 25 miles from BIDMC

Exclusion criteria

  • Patient to sick to be interviewed
  • Absence of severe symptoms
  • Participating in another trial
  • Language barrier
  • MD does not provide permission
  • Expired prior to consent process

Treatment and study plan

management of therapy complications

Procedure

Massage therapy

Procedure

pain therapy

Procedure

psychosocial assessment and care

Procedure

quality-of-life assessment

Procedure

Primary outcomes

  1. Pain

    Time frame: From baseline to 1 week and from baseline to one month

    0=no pain to 10=most severe pain

  2. Anxiety

    Time frame: From baseline to 1 week and from baseline to 1 month

    0=no anxiety to 10=most severe anxiety

  3. Alertness

    Time frame: From baseline to 1 week and from baseline to 1 month

    0=not at all alert to 10=most alert

Secondary outcomes

  1. Quality of Life: Physical Well-being

    Time frame: From baseline to 1 week and from baseline to 1 month

    Physical well-being over past 2 days (0= physically terrible to 10= physically well)

  2. Quality of Life: Psychological Well-being

    Time frame: From baseline to 1 week and from baseline to 1 month

    Psychological well-being over past 2 days (depressed, nervous/worried, sad, terrified of future) (0= always/extremely to 10= never/not at all; in other words: 0=negative/worst to 10= positive/best)

  3. Quality of Life: McGill Total

    Time frame: From baseline to 1 week and from baseline to 1 month

    Quality of Life (McGill Total); Mean of five sub-measures (but not overall) (0 = negative to 10 = positive)

  4. Sleep

    Time frame: From baseline to 1 week and from baseline to 1 month

    Sleep (Richards-Campbell) 0 = best sleep to 50 = worst sleep

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Body-Based Complementary Therapies for Patients With Cancer

Important dates

Study start
2004
Primary completion
2013
Study completion
2013
First posted
Nov 15, 2005
Registry last updated
Aug 7, 2017

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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