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



Status:Completed
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:2/1/2017
Start Date:December 1, 2004
End Date:January 1, 2013

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Body-Based Complementary Therapies for Patients With 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.

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.

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)
We found this trial at
1
site
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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mi
from
Boston, MA
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