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

• Safety and adverse effects as reported by patient after days 1 and 3 in first randomization, by caregiver at weeks 2 and 4 in second randomization, by therapist after days 1, 2, and 3 in first randomization
  
• Safety and adverse effects as measured by medical records after completion of study treatment, by mortality rates, and blinded oncologist review of serious adverse events
  
• Percentage of eligible patients willing to participate
  
• Tolerated dose of massage in terms of average duration, frequent techniques used, and average pressure used correlated with adverse effects on days 1-3
  
• Massage effect on pain as measured by Brief Pain Inventory at baseline vs day 71 in first randomization, and day 7 vs day 40 in second randomization
  
• Feasibility of teaching caregivers how to provide massage therapy as measured by percent of randomized dyads completing caregiver training, and the number of times per week massage is performed in weeks 2 and 4
  
• Efficacy of massage to facilitate a phase III design at baseline vs day 71 in first randomization and day 7 vs day 40 in second randomization
  

• Massage effect on intensity of anxiety, depression, shortness of breath, nausea and quality of sleep by patient report at baseline vs day 71 in first randomization and day 7 vs day 40 in second randomization
  
• Massage effect on intensity of anxiety, depression, shortness of breath, nausea and quality of sleep by Profile of Mood States subscales of anxiety and depression at baseline vs day 71 in 1st randomiz. & day 7 vs day 40 in 2nd randomiz.
  
• Massage effect on intensity of anxiety, depression, shortness of breath, nausea and quality of sleep by McGill Quality of Life at baseline vs day 71 in first randomization and day 7 vs day 40 in second randomization
  
• Massage effect on intensity of anxiety, depression, shortness of breath, nausea and quality of sleep by Pos. and Neg. Affect Schedule (PANAS) pos. affect subscale at baseline vs day 71 in 1st randomiz. and day 7 vs day 40 in 2nd randomiz.
  
• Massage effect on intensity of anxiety, depression, shortness of breath, nausea and quality of sleep by positive states of mind at baseline vs day 71 in 1st randomization and day 7 vs day 40 in 2nd randomiz.
  
• Massage effect on quality of sleep by Richards-Campbell Sleep Questionnaire
  
• Simple presence (no touch) massage therapy contr. group acceptability to patients by avg. duration of treatment at days 1-3
  
• Comparison of average pre- and post-treatment session pulse, respiratory rates, and symptom rating between massage and no touch groups at days 1-3
  
• Effects of massage on the caregiver by Caregiver Reaction Assessment, Caregiver POMS Anxiety and Depression subscales, PANAS positive affect subscale, positive states of mind at week 1 vs day 40
  
• Effects of massage on the caregiver by qualitative interview of patients and caregivers for positive or negative effects on patient, caregiver, and their relationship at completion of study treatment
  

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.