Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

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

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.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of 1 of the following:
  -  Locally advanced, unresectable disease of 1 of the following types:
  -  Non-small cell lung cancer
  -  Stage III or IV disease
  -  Gastric cancer
  -  Esophageal cancer
  -  Hepatobiliary cancer
  -  Colon cancer
  -  Metastatic disease of 1 of the following types:
  -  Small cell lung cancer
  -  Renal cancer
  -  Bladder cancer
  -  Melanoma
  -  Prostate cancer
  -  Breast cancer
  -  Ovarian cancer
  -  Not amenable to curative treatment
  -  Receiving treatment at Beth Israel Deaconess Medical Center (BIDMC)
  -  Anticipated hospital stay > 3 days OR registered patient at the outpatient oncology clinic
  -  Must reside ≤ 50 miles from BIDMC
  -  Current symptoms (i.e., pain, nausea, shortness of breath, anxiety, and depression) rating ≥ 3/10 by patient report (2/10 for patients who have received an opioid analgesic within the past 24 hours)
  PATIENT CHARACTERISTICS:
  Performance status
  -  Not specified
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  Other
  -  No cognitive impairment or other reason that would preclude giving informed consent
  PRIOR CONCURRENT THERAPY:
  Other
  -  No prior randomization on this study
  -  No other concurrent massage or energy therapies (e.g., Reiki)

Relevance to patient case: not relevant