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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Body-Based Complementary Therapies for Patients With Cancer

Conditions
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Cancer

Intervention / Treatment
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* Procedure: management of therapy complications
* Procedure: massage therapy
* Procedure: pain therapy
* Procedure: psychosocial assessment and care
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study was designed to assess the feasibility and effectiveness of massage for patients with cancer-related pain
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: massage<br>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 | Procedure: management of therapy complications<br> <br> Procedure: massage therapy<br> <br> Procedure: pain therapy<br> <br> Procedure: psychosocial assessment and care<br> <br> Procedure: quality-of-life assessment<br> <br> |
| Active Comparator: no-touch control<br>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 | Procedure: management of therapy complications<br> <br> Procedure: massage therapy<br> <br> Procedure: pain therapy<br> <br> Procedure: psychosocial assessment and care<br> <br> Procedure: quality-of-life assessment<br> <br> |
| No Intervention: Usual care<br>Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | 0=no pain to 10=most severe pain | From baseline to 1 week and from baseline to one month | 
| Anxiety | 0=no anxiety to 10=most severe anxiety | From baseline to 1 week and from baseline to 1 month | 
| Alertness | 0=not at all alert to 10=most alert | From baseline to 1 week and from baseline to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life: Physical Well-being | Physical well-being over past 2 days (0= physically terrible to 10= physically well) | From baseline to 1 week and from baseline to 1 month | 
| Quality of Life: Psychological Well-being | 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) | From baseline to 1 week and from baseline to 1 month | 
| Quality of Life: McGill Total | Quality of Life (McGill Total); Mean of five sub-measures (but not overall) (0 = negative to 10 = positive) | From baseline to 1 week and from baseline to 1 month | 
| Sleep | Sleep (Richards-Campbell) 0 = best sleep to 50 = worst sleep | From baseline to 1 week and from baseline to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, nausea and vomiting, pain, psychosocial effects of cancer and its treatment, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, extensive stage small cell lung cancer, stage III gastric cancer, stage III esophageal cancer, localized unresectable adult primary liver cancer, stage III colon cancer, stage IV renal cell cancer, stage IV bladder cancer, stage IV prostate cancer, stage IV breast cancer, stage IV ovarian epithelial cancer, advanced adult primary liver cancer, stage IV melanoma, stage IV ovarian germ cell tumor, ovarian sarcoma, ovarian stromal cancer, recurrent small cell lung cancer, recurrent adult primary liver cancer, recurrent colon cancer, recurrent esophageal cancer, recurrent gastric cancer, recurrent non-small cell lung cancer, recurrent bladder cancer, recurrent breast cancer, recurrent ovarian epithelial cancer, recurrent ovarian germ cell tumor, recurrent prostate cancer, recurrent renal cell cancer, recurrent melanoma