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Body-Based Complementary Therapies for Patients With Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Cancer

Thank you

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.

Inclusion Criteria


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Single Blind, Primary Purpose: Supportive Care

Outcome Measure:

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

Principal Investigator

Russell S. Phillips, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000445117

NCT ID:

NCT00253708

Start Date:

December 2003

Completion Date:

Related Keywords:

  • Cancer
  • 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

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215