Body-Based Complementary Therapies for Patients With Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Anxiety
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: psychosocial assessment and care (Procedure)
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
Intervention: quality-of-life assessment (Procedure)
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
Intervention: management of therapy complications (Procedure)
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
Intervention: massage therapy (Procedure)
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
Intervention: pain therapy (Procedure)
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
Intervention: management of therapy complications (Procedure)
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
Intervention: massage therapy (Procedure)
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
Intervention: pain therapy (Procedure)
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
Intervention: psychosocial assessment and care (Procedure)
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
Intervention: quality-of-life assessment (Procedure)
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
Outcomes
Primary Outcomes
Anxiety
Time Frame: From baseline to 1 week and from baseline to 1 month
0=no anxiety to 10=most severe anxiety
Alertness
Time Frame: From baseline to 1 week and from baseline to 1 month
0=not at all alert to 10=most alert
Pain
Time Frame: From baseline to 1 week and from baseline to one month
0=no pain to 10=most severe pain
Secondary Outcomes
- Quality of Life: Physical Well-being(From baseline to 1 week and from baseline to 1 month)
- Quality of Life: Psychological Well-being(From baseline to 1 week and from baseline to 1 month)
- Quality of Life: McGill Total(From baseline to 1 week and from baseline to 1 month)
- Sleep(From baseline to 1 week and from baseline to 1 month)
Investigators
Russell Phillips
Principal Investigator
Beth Israel Deaconess Medical Center