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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000445117 | Registry Identifier | PDQ (Physician Data Query) | |
| R21CA098487 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE: This is a randomized, controlled, pilot study. Patients are randomized to 1 of 3 treatment arms.
All patients are then randomized (a second time) to 1 of 2 treatment arms.
PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| massage | Experimental | Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment |
|
| no-touch control | Active Comparator | Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment |
|
| Usual care | No Intervention | Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| management of therapy complications | Procedure |
| ||
| massage therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | 0=no pain to 10=most severe pain | From baseline to 1 week and from baseline to one month |
| Anxiety | 0=no anxiety to 10=most severe anxiety | From baseline to 1 week and from baseline to 1 month |
| Alertness | 0=not at all alert to 10=most alert | From baseline to 1 week and from baseline to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life: Physical Well-being | Physical well-being over past 2 days (0= physically terrible to 10= physically well) | From baseline to 1 week and from baseline to 1 month |
| Quality of Life: Psychological Well-being |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Russell S. Phillips, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23368724 | Result | 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. |
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Using oncology clinic electronic database, eligible patients were selected based on their clinical diagnosis (solid cancer with evidence of metastases) and whether they lived within 25 miles of the hospital. Patients were told that the authors were conducting a study of nonpharmacologic treatments intended to improve symptom management.
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| ID | Title | Description |
|---|---|---|
| FG000 | Touch Intervention (Massage Therapy) | Patients received three visits by the professional massage therapists over the first week after the enrollment. Massage treatments were scheduled based on patient preferences, and the duration was between 15 and 45 minutes; both the duration and the amount of pressure was modified depending on patient comfort. A limited scope of practice was provided to the massage therapists that specified the allowed and disallowed massage modalities and techniques. Allowed techniques were both Swedish and non-Swedish massage including gliding/effleurage, gentle kneading/petrissage, compression, gentle stretching, rocking, light myofascial release, active and/or passive range of motion, warm or cool applications, and use of acupressure points as well as craniosacral holds thought to have calming and centering effects. No forms of friction, deep-tissue massage, or bodywork forms that required movement by the patients were allowed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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The study was designed to assess the feasibility and effectiveness of massage for patients with cancer-related pain
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| Procedure |
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| pain therapy | Procedure |
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| psychosocial assessment and care | Procedure |
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| quality-of-life assessment | Procedure |
|
Psychological well-being over past 2 days (depressed, nervous/worried, sad, terrified of future) (0= always/extremely to 10= never/not at all; in other words: 0=negative/worst to 10= positive/best)
| From baseline to 1 week and from baseline to 1 month |
| Quality of Life: McGill Total | Quality of Life (McGill Total); Mean of five sub-measures (but not overall) (0 = negative to 10 = positive) | From baseline to 1 week and from baseline to 1 month |
| Sleep | Sleep (Richards-Campbell) 0 = best sleep to 50 = worst sleep | From baseline to 1 week and from baseline to 1 month |
| FG001 | No Touch Intervention (Control) | The authors wanted to separate out the effect of interacting with a massage therapist from massage itself, so the therapists performed no-touch control interventions, which had no healing intention. Although most of the therapists had experience with energy healing, the therapists were trained to avoid ''healing intention'' in the no-touch group by using distraction if necessary, created by counting backwards. For the no-touch control intervention, therapists were instructed to be with the patients between 15 and 45 minutes, depending on the patient's tolerance, and to hold their hands about 12 inches over the patient's body. In the usual-care control group, patients completed the same questionnaires but did not receive any visits from the massage therapists. |
| FG002 | Usual Care (Control) | Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Massage | Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment management of therapy complications massage therapy pain therapy psychosocial assessment and care quality-of-life assessment |
| BG001 | No-touch Control | Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment management of therapy complications massage therapy pain therapy psychosocial assessment and care quality-of-life assessment |
| BG002 | Usual Care | Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Marital status: Married, Other | Count of Participants | Participants |
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| Living alone | Count of Participants | Participants |
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| Not admitted to hospital in the last 12 months | Count of Participants | Participants |
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| Education: College grad or more | Count of Participants | Participants |
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| Employment: full-time or part-time | Count of Participants | Participants |
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| Household income: Not available/refused/don't know, <$50,000, >$50,000 | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain | 0=no pain to 10=most severe pain | Posted | Median | Inter-Quartile Range | units on a scale | From baseline to 1 week and from baseline to one month |
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| Primary | Anxiety | 0=no anxiety to 10=most severe anxiety | Posted | Median | Inter-Quartile Range | units on a scale | From baseline to 1 week and from baseline to 1 month |
| |||||||||||||||||||||||||||||||||||
| Primary | Alertness | 0=not at all alert to 10=most alert | Posted | Median | Inter-Quartile Range | units on a scale | From baseline to 1 week and from baseline to 1 month |
| |||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life: Physical Well-being | Physical well-being over past 2 days (0= physically terrible to 10= physically well) | Posted | Median | Inter-Quartile Range | units on a scale | From baseline to 1 week and from baseline to 1 month |
| |||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life: Psychological Well-being | Psychological well-being over past 2 days (depressed, nervous/worried, sad, terrified of future) (0= always/extremely to 10= never/not at all; in other words: 0=negative/worst to 10= positive/best) | Posted | Median | Inter-Quartile Range | units on a scale | From baseline to 1 week and from baseline to 1 month |
| |||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life: McGill Total | Quality of Life (McGill Total); Mean of five sub-measures (but not overall) (0 = negative to 10 = positive) | Posted | Median | Inter-Quartile Range | units on a scale | From baseline to 1 week and from baseline to 1 month |
| |||||||||||||||||||||||||||||||||||
| Secondary | Sleep | Sleep (Richards-Campbell) 0 = best sleep to 50 = worst sleep | Posted | Median | Inter-Quartile Range | units on a scale | From baseline to 1 week and from baseline to 1 month |
|
From baseline to 1 month
There were no study-related adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Massage | Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment management of therapy complications massage therapy pain therapy psychosocial assessment and care quality-of-life assessment | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | No-touch Control | Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment management of therapy complications massage therapy pain therapy psychosocial assessment and care quality-of-life assessment | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Usual Care | Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment | 1 | 9 | 0 | 9 | 0 | 9 |
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Small sample size limited statistical power. Pre-post intervention data collection was not blinded. Patient bias in massage group. Heterogeneity in type and stage of cancer may have resulted in variation of the effects of the interventions.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Russell S. Phillips, MD | Beth Israel Deaconess Medical Center | 6174322222 | Russell_phillips@hms.harvard.edu |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003863 | Depression |
| D009325 | Nausea |
| D014839 | Vomiting |
| D010146 | Pain |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| D003110 | Colonic Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D001749 | Urinary Bladder Neoplasms |
| D011471 | Prostatic Neoplasms |
| D001943 | Breast Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D008545 | Melanoma |
| D055752 | Small Cell Lung Carcinoma |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D011469 | Prostatic Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D008405 | Massage |
| D000698 | Analgesia |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000760 | Anesthesia and Analgesia |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Male |
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| White |
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| Other |
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| <$50,000 |
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| >$50,000 |
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Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
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