Clinical trial NCT00253708: Massage Therapy in Treating the Symptoms of Patients With Locally Advanced or Metastatic Cancer
Official title: Body-Based Complementary Therapies for Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: 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
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-11-15
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was designed to assess the feasibility and effectiveness of massage for patients with cancer-related pain
Primary purpose: SUPPORTIVE_CARE

Brief 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 criteria: Inclusion criteria:

* Solid cancer with evidence of metastases
* Receiving treatment at Beth Israel Deaconess Medical Center (BIDMC)
* Must reside ≤ 25 miles from BIDMC

Exclusion criteria:

* Patient to sick to be interviewed
* Absence of severe symptoms
* Participating in another trial
* Language barrier
* MD does not provide permission
* Expired prior to consent process

Primary outcomes:
measure: Pain
timeFrame: From baseline to 1 week and from baseline to one month
measure: Anxiety
timeFrame: From baseline to 1 week and from baseline to 1 month
measure: Alertness
timeFrame: From baseline to 1 week and from baseline to 1 month
Secondary outcomes:
measure: Quality of Life: Physical Well-being
timeFrame: From baseline to 1 week and from baseline to 1 month
measure: Quality of Life: Psychological Well-being
timeFrame: From baseline to 1 week and from baseline to 1 month
measure: Quality of Life: McGill Total
timeFrame: From baseline to 1 week and from baseline to 1 month
measure: Sleep
timeFrame: From baseline to 1 week and from baseline to 1 month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Russell S. Phillips, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Epub 2013 Jan 31.