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

Beth Israel Lahey Health

Status: Completed

Conditions: Cancer

Treatments: Procedure: psychosocial assessment and care; Procedure: massage therapy; Procedure: quality-of-life assessment; Procedure: pain therapy; Procedure: management of therapy complications

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00253708

2003P000299

CDR0000445117 (Registry Identifier)

R21CA098487 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 3 patient groups

massage

Experimental group

Description:

Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment

Treatment:

Procedure: quality-of-life assessment

Procedure: psychosocial assessment and care

Procedure: pain therapy

Procedure: management of therapy complications

Procedure: massage therapy

no-touch control

Active Comparator group

Description:

Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment

Treatment:

Procedure: quality-of-life assessment

Procedure: psychosocial assessment and care

Procedure: pain therapy

Procedure: management of therapy complications

Procedure: massage therapy

Usual care

No Intervention group

Description:

Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment