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

Cancer Clinical Trial

Official title:

Body-Based Complementary Therapies for Patients With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253708
• Other study ID #: BIDMC-2003P-000299
• Secondary ID: CDR0000445117R21
• Status: Completed
• Phase: N/A
• First received: November 11, 2005
• Last updated: January 30, 2017
• Start date: December 1, 2004
• Est. completion date: January 1, 2013

Study information

• Verified date: January 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 1, 2013
• Est. primary completion date: January 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

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)

Related Conditions & MeSH terms

• Cancer

Intervention

Procedure:
• management of therapy complications

• massage therapy

• pain therapy

• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Toth M, Marcantonio ER, Davis RB, Walton T, Kahn JR, Phillips RS. Massage therapy for patients with metastatic cancer: a pilot randomized controlled trial. J Altern Complement Med. 2013 Jul;19(7):650-6. doi: 10.1089/acm.2012.0466. — View Citation

Outcome

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