Overview

This trial is active, not recruiting.

Condition cancer
Treatments management of therapy complications, massage therapy, pain therapy, psychosocial assessment and care, quality-of-life assessment
Sponsor Beth Israel Deaconess Medical Center
Collaborator National Cancer Institute (NCI)
Start date December 2003
Trial identifier NCT00253708, BIDMC-2003P-000299, CDR0000445117

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Masking single blind
Primary purpose supportive care

Primary Outcomes

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
time frame:
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
time frame:
Percentage of eligible patients willing to participate
time frame:
Tolerated dose of massage in terms of average duration, frequent techniques used, and average pressure used correlated with adverse effects on days 1-3
time frame:
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
time frame:
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
time frame:
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
time frame:

Secondary Outcomes

Measure
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
time frame:
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.
time frame:
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
time frame:
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.
time frame:
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.
time frame:
Massage effect on quality of sleep by Richards-Campbell Sleep Questionnaire
time frame:
Simple presence (no touch) massage therapy contr. group acceptability to patients by avg. duration of treatment at days 1-3
time frame:
Comparison of average pre- and post-treatment session pulse, respiratory rates, and symptom rating between massage and no touch groups at days 1-3
time frame:
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
time frame:
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
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Body-Based Complementary Therapies for Patients With Cancer
Principal investigator Russell S. Phillips, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).