NCT00253708

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

Body-Based Complementary Therapies for Patients With Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cancer

Interventions

Type	Name	Description
PROCEDURE	management of therapy complications
PROCEDURE	massage therapy
PROCEDURE	pain therapy
PROCEDURE	psychosocial assessment and care
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2004-12-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2005-11-15
• Last updated: 2017-08-07
• Results posted: 2017-08-07

Locations

1 site across 1 country: United States