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

Not Applicable

Completed

Conditions: Cancer

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

Registration Number: NCT00253708

Lead Sponsor: Beth Israel Deaconess Medical Center

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.

* 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
massage	pain therapy	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
massage	psychosocial assessment and care	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
massage	management of therapy complications	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
massage	massage therapy	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
no-touch control	pain therapy	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
no-touch control	massage therapy	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
massage	quality-of-life assessment	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
no-touch control	management of therapy complications	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
no-touch control	psychosocial assessment and care	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
no-touch control	quality-of-life assessment	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

Primary Outcome Measures

Name	Time	Method
Anxiety	From baseline to 1 week and from baseline to 1 month	0=no anxiety to 10=most severe anxiety
Alertness	From baseline to 1 week and from baseline to 1 month	0=not at all alert to 10=most alert
Pain	From baseline to 1 week and from baseline to one month	0=no pain to 10=most severe pain

Secondary Outcome Measures

Name	Time	Method
Quality of Life: Physical Well-being	From baseline to 1 week and from baseline to 1 month	Physical well-being over past 2 days (0= physically terrible to 10= physically well)
Quality of Life: Psychological Well-being	From baseline to 1 week and from baseline to 1 month	Psychological well-being over past 2 days (depressed, nervous/worried, sad, terrified of future) (0= always/extremely to 10= never/not at all; in other words: 0=negative/worst to 10= positive/best)
Quality of Life: McGill Total	From baseline to 1 week and from baseline to 1 month	Quality of Life (McGill Total); Mean of five sub-measures (but not overall) (0 = negative to 10 = positive)
Sleep	From baseline to 1 week and from baseline to 1 month	Sleep (Richards-Campbell) 0 = best sleep to 50 = worst sleep