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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00253708
First received: November 11, 2005
Last updated: August 19, 2009
Last verified: December 2005
  Purpose

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.


Condition Intervention
Cancer
Procedure: management of therapy complications
Procedure: massage therapy
Procedure: pain therapy
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Single Blind
Primary Purpose: Supportive Care
Official Title: Body-Based Complementary Therapies for Patients With Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety and adverse effects as reported by patient after days 1 and 3 in first randomization, by caregiver at weeks 2 and 4 in second randomization, by therapist after days 1, 2, and 3 in first randomization
  • Safety and adverse effects as measured by medical records after completion of study treatment, by mortality rates, and blinded oncologist review of serious adverse events
  • Percentage of eligible patients willing to participate
  • Tolerated dose of massage in terms of average duration, frequent techniques used, and average pressure used correlated with adverse effects on days 1-3
  • Massage effect on pain as measured by Brief Pain Inventory at baseline vs day 71 in first randomization, and day 7 vs day 40 in second randomization
  • Feasibility of teaching caregivers how to provide massage therapy as measured by percent of randomized dyads completing caregiver training, and the number of times per week massage is performed in weeks 2 and 4
  • Efficacy of massage to facilitate a phase III design at baseline vs day 71 in first randomization and day 7 vs day 40 in second randomization

Secondary Outcome Measures:
  • Massage effect on intensity of anxiety, depression, shortness of breath, nausea and quality of sleep by patient report at baseline vs day 71 in first randomization and day 7 vs day 40 in second randomization
  • Massage effect on intensity of anxiety, depression, shortness of breath, nausea and quality of sleep by Profile of Mood States subscales of anxiety and depression at baseline vs day 71 in 1st randomiz. & day 7 vs day 40 in 2nd randomiz.
  • Massage effect on intensity of anxiety, depression, shortness of breath, nausea and quality of sleep by McGill Quality of Life at baseline vs day 71 in first randomization and day 7 vs day 40 in second randomization
  • Massage effect on intensity of anxiety, depression, shortness of breath, nausea and quality of sleep by Pos. and Neg. Affect Schedule (PANAS) pos. affect subscale at baseline vs day 71 in 1st randomiz. and day 7 vs day 40 in 2nd randomiz.
  • Massage effect on intensity of anxiety, depression, shortness of breath, nausea and quality of sleep by positive states of mind at baseline vs day 71 in 1st randomization and day 7 vs day 40 in 2nd randomiz.
  • Massage effect on quality of sleep by Richards-Campbell Sleep Questionnaire
  • Simple presence (no touch) massage therapy contr. group acceptability to patients by avg. duration of treatment at days 1-3
  • Comparison of average pre- and post-treatment session pulse, respiratory rates, and symptom rating between massage and no touch groups at days 1-3
  • Effects of massage on the caregiver by Caregiver Reaction Assessment, Caregiver POMS Anxiety and Depression subscales, PANAS positive affect subscale, positive states of mind at week 1 vs day 40
  • Effects of massage on the caregiver by qualitative interview of patients and caregivers for positive or negative effects on patient, caregiver, and their relationship at completion of study treatment

Study Start Date: December 2003
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • Locally advanced, unresectable disease of 1 of the following types:

      • Non-small cell lung cancer

        • Stage III or IV disease
      • Gastric cancer
      • Esophageal cancer
      • Hepatobiliary cancer
      • Colon cancer
    • Metastatic disease of 1 of the following types:

      • Small cell lung cancer
      • Renal cancer
      • Bladder cancer
      • Melanoma
      • Prostate cancer
      • Breast cancer
      • Ovarian cancer
  • Not amenable to curative treatment
  • Receiving treatment at Beth Israel Deaconess Medical Center (BIDMC)

    • Anticipated hospital stay > 3 days OR registered patient at the outpatient oncology clinic
    • Must reside ≤ 50 miles from BIDMC
  • Current symptoms (i.e., pain, nausea, shortness of breath, anxiety, and depression) rating ≥ 3/10 by patient report (2/10 for patients who have received an opioid analgesic within the past 24 hours)

PATIENT CHARACTERISTICS:

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • No cognitive impairment or other reason that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

Other

  • No prior randomization on this study
  • No other concurrent massage or energy therapies (e.g., Reiki)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00253708

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Russell S. Phillips, MD Beth Israel Deaconess Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00253708     History of Changes
Other Study ID Numbers: CDR0000445117, BIDMC-2003P-000299
Study First Received: November 11, 2005
Last Updated: August 19, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
depression
nausea and vomiting
pain
psychosocial effects of cancer and its treatment
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
extensive stage small cell lung cancer
stage III gastric cancer
stage III esophageal cancer
localized unresectable adult primary liver cancer
stage III colon cancer
stage IV renal cell cancer
stage IV bladder cancer
stage IV prostate cancer
stage IV breast cancer
stage IV ovarian epithelial cancer
advanced adult primary liver cancer
stage IV melanoma
stage IV ovarian germ cell tumor
ovarian sarcoma
ovarian stromal cancer
recurrent small cell lung cancer
recurrent adult primary liver cancer
recurrent colon cancer
recurrent esophageal cancer
recurrent gastric cancer
recurrent non-small cell lung cancer
recurrent bladder cancer
recurrent breast cancer

ClinicalTrials.gov processed this record on September 14, 2014