Trial Information

Body-Based Complementary Therapies for Patients With Cancer

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.