Massage Therapy in Treating the Symptoms of Patients With Locally Advanced or Metastatic Cancer
Summary
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.
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.
Study Design
Allocation: Randomized, Control: Active Control, Masking: Single Blind, Primary Purpose: Supportive Care
Conditions
Cancer
Intervention
management of therapy complications, massage therapy, pain therapy, psychosocial assessment and care, quality-of-life assessment
Location
Beth Israel Deaconess Medical Center
Boston
Massachusetts
United States
02215
Status
Active, not recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00253708
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Neoadjuvant Therapy
Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.
Salvage Therapy
A therapeutic approach, involving chemotherapy, radiation therapy, or surgery, after initial regimens have failed to lead to improvement in a patient's condition. Salvage therapy is most often used for neoplastic diseases.
Laser Therapy, Low-level
Treatment using irradiation with LASER light of low power intensity so that the effects are not due to heat, as in LASER THERAPY. These non-thermal effects are thought to be mediated by a photochemical reaction that alters CELL MEMBRANE PERMEABILITY, leading to increased mRNA synthesis and CELL PROLIFERATION. Low-level laser therapy has been used for a wide variety of conditions, but most frequently for wound healing and pain control.
Chemotherapy, Adjuvant
Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.
Medication Therapy Management
Assistance in managing and monitoring drug therapy for patients receiving treatment for cancer or chronic conditions such as asthma and diabetes, consulting with patients and their families on the proper use of medication; conducting wellness and disease prevention programs to improve public health; overseeing medication use in a variety of settings.
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