Massage Therapy in Treating the Symptoms of Patients With Locally Advanced or Metastatic Cancer
NCT ID: NCT00253708
Last Updated: 2017-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2004-12-01
2013-01-01
Brief Summary
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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.
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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massage
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
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment
no-touch control
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
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment
Usual care
Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
No interventions assigned to this group
Interventions
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management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* Receiving treatment at Beth Israel Deaconess Medical Center (BIDMC)
* Must reside ≤ 25 miles from BIDMC
Exclusion Criteria
* Absence of severe symptoms
* Participating in another trial
* Language barrier
* MD does not provide permission
* Expired prior to consent process
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Russell Phillips
Principal Investigator
Principal Investigators
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Russell S. Phillips, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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References
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Toth M, Marcantonio ER, Davis RB, Walton T, Kahn JR, Phillips RS. Massage therapy for patients with metastatic cancer: a pilot randomized controlled trial. J Altern Complement Med. 2013 Jul;19(7):650-6. doi: 10.1089/acm.2012.0466. Epub 2013 Jan 31.
Other Identifiers
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CDR0000445117
Identifier Type: REGISTRY
Identifier Source: secondary_id
2003P000299
Identifier Type: -
Identifier Source: org_study_id
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