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NCT00253708 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2017-08-07

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Pain

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outcome · POSTED

Anxiety

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outcome · POSTED

Alertness

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outcome · POSTED

Quality of Life: Physical Well-being

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outcome · POSTED

Quality of Life: Psychological Well-being

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outcome · POSTED

Quality of Life: McGill Total

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outcome · POSTED

Sleep

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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
    intervention Names
    1. Procedure: management of therapy complications
    2. Procedure: massage therapy
    3. Procedure: pain therapy
    4. Procedure: psychosocial assessment and care
    5. Procedure: quality-of-life assessment
    label
    massage
    type
    EXPERIMENTAL
  2. description
    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
    intervention Names
    1. Procedure: management of therapy complications
    2. Procedure: massage therapy
    3. Procedure: pain therapy
    4. Procedure: psychosocial assessment and care
    5. Procedure: quality-of-life assessment
    label
    no-touch control
    type
    ACTIVE_COMPARATOR
  3. description
    Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
    label
    Usual care
    type
    NO_INTERVENTION
interventions
  1. arm Group Labels
    1. massage
    2. no-touch control
    name
    management of therapy complications
    type
    PROCEDURE
  2. arm Group Labels
    1. massage
    2. no-touch control
    name
    massage therapy
    type
    PROCEDURE
  3. arm Group Labels
    1. massage
    2. no-touch control
    name
    pain therapy
    type
    PROCEDURE
  4. arm Group Labels
    1. massage
    2. no-touch control
    name
    psychosocial assessment and care
    type
    PROCEDURE
  5. arm Group Labels
    1. massage
    2. no-touch control
    name
    quality-of-life assessment
    type
    PROCEDURE
Study design
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
masking Info
masking
DOUBLE
who Masked
  1. INVESTIGATOR
  2. OUTCOMES_ASSESSOR
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
39
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    0=no pain to 10=most severe pain
    measure
    Pain
    time Frame
    From baseline to 1 week and from baseline to one month
  2. description
    0=no anxiety to 10=most severe anxiety
    measure
    Anxiety
    time Frame
    From baseline to 1 week and from baseline to 1 month
  3. description
    0=not at all alert to 10=most alert
    measure
    Alertness
    time Frame
    From baseline to 1 week and from baseline to 1 month
secondary Outcomes
  1. description
    Physical well-being over past 2 days (0= physically terrible to 10= physically well)
    measure
    Quality of Life: Physical Well-being
    time Frame
    From baseline to 1 week and from baseline to 1 month
  2. description
    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)
    measure
    Quality of Life: Psychological Well-being
    time Frame
    From baseline to 1 week and from baseline to 1 month
  3. description
    Quality of Life (McGill Total); Mean of five sub-measures (but not overall) (0 = negative to 10 = positive)
    measure
    Quality of Life: McGill Total
    time Frame
    From baseline to 1 week and from baseline to 1 month
  4. description
    Sleep (Richards-Campbell) 0 = best sleep to 50 = worst sleep
    measure
    Sleep
    time Frame
    From baseline to 1 week and from baseline to 1 month
Full study description
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.
Source references
references
  1. 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.
    pmid
    23368724
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice