Massage Therapy in Treating the Symptoms of Patients With Locally Advanced or Metastatic Cancer
Condition: Cancer
Study type: Interventional

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.
    

Intervention name(s): management of therapy complications; massage therapy; pain therapy; psychosocial assessment and care; quality-of-life assessment
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was designed to assess the feasibility and effectiveness of massage for patients with cancer-related pain
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: 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