Trial Outcomes & Findings for Massage Therapy in Treating the Symptoms of Patients With Locally Advanced or Metastatic Cancer (NCT NCT00253708)
NCT ID: NCT00253708
Last Updated: 2017-08-07
Results Overview
0=no pain to 10=most severe pain
COMPLETED
NA
39 participants
From baseline to 1 week and from baseline to one month
2017-08-07
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
10
|
9
|
|
Overall Study
COMPLETED
|
20
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Massage Therapy in Treating the Symptoms of Patients With Locally Advanced or Metastatic Cancer
Baseline characteristics by cohort
| Measure |
Massage
n=20 Participants
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
|
No-touch Control
n=10 Participants
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
|
Usual Care
n=9 Participants
Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.9 years
STANDARD_DEVIATION 12 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 10 • n=7 Participants
|
55.6 years
STANDARD_DEVIATION 9 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 11 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Marital status: Married, Other
Married
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Marital status: Married, Other
Other
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Living alone
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Not admitted to hospital in the last 12 months
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Education: College grad or more
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Employment: full-time or part-time
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Household income: Not available/refused/don't know, <$50,000, >$50,000
Not available/refused/Don't know
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Household income: Not available/refused/don't know, <$50,000, >$50,000
<$50,000
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Household income: Not available/refused/don't know, <$50,000, >$50,000
>$50,000
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline to 1 week and from baseline to one month0=no pain to 10=most severe pain
Outcome measures
| Measure |
Massage
n=20 Participants
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
|
No-touch Control
n=10 Participants
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
|
Usual Care
n=9 Participants
Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
|
|---|---|---|---|
|
Pain
1 month
|
0 units on a scale
Interval -1.0 to 0.0
|
0 units on a scale
Interval -1.5 to 0.0
|
-2 units on a scale
Interval -2.0 to -1.0
|
|
Pain
1 week
|
0 units on a scale
Interval -2.0 to 1.0
|
0 units on a scale
Interval -1.0 to 2.0
|
0 units on a scale
Interval -3.0 to 2.0
|
PRIMARY outcome
Timeframe: From baseline to 1 week and from baseline to 1 month0=no anxiety to 10=most severe anxiety
Outcome measures
| Measure |
Massage
n=20 Participants
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
|
No-touch Control
n=10 Participants
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
|
Usual Care
n=9 Participants
Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
|
|---|---|---|---|
|
Anxiety
1 week
|
0 units on a scale
Interval -3.0 to 0.0
|
0 units on a scale
Interval -3.0 to 0.0
|
0 units on a scale
Interval -2.0 to 0.0
|
|
Anxiety
1 month
|
0 units on a scale
Interval -2.0 to 0.0
|
0 units on a scale
Interval -1.5 to 1.0
|
0 units on a scale
Interval -3.0 to 0.0
|
PRIMARY outcome
Timeframe: From baseline to 1 week and from baseline to 1 month0=not at all alert to 10=most alert
Outcome measures
| Measure |
Massage
n=20 Participants
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
|
No-touch Control
n=10 Participants
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
|
Usual Care
n=9 Participants
Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
|
|---|---|---|---|
|
Alertness
1 week
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval -0.5 to 0.0
|
1 units on a scale
Interval 0.0 to 2.0
|
|
Alertness
1 month
|
0 units on a scale
Interval -1.0 to 0.0
|
0 units on a scale
Interval -1.5 to 0.0
|
0 units on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: From baseline to 1 week and from baseline to 1 monthPhysical well-being over past 2 days (0= physically terrible to 10= physically well)
Outcome measures
| Measure |
Massage
n=20 Participants
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
|
No-touch Control
n=10 Participants
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
|
Usual Care
n=9 Participants
Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
|
|---|---|---|---|
|
Quality of Life: Physical Well-being
1 month
|
0 units on a scale
Interval -1.0 to 1.0
|
0 units on a scale
Interval -3.5 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Quality of Life: Physical Well-being
1 week
|
1 units on a scale
Interval 0.0 to 2.0
|
-0.5 units on a scale
Interval -2.0 to 0.5
|
0 units on a scale
Interval -2.0 to 0.0
|
SECONDARY outcome
Timeframe: From baseline to 1 week and from baseline to 1 monthPsychological 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)
Outcome measures
| Measure |
Massage
n=20 Participants
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
|
No-touch Control
n=10 Participants
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
|
Usual Care
n=9 Participants
Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
|
|---|---|---|---|
|
Quality of Life: Psychological Well-being
1 week
|
1.125 units on a scale
Interval 0.0 to 2.0
|
0.25 units on a scale
Interval -0.5 to 2.0
|
0 units on a scale
Interval 0.0 to 0.75
|
|
Quality of Life: Psychological Well-being
1 month
|
-0.125 units on a scale
Interval -0.5 to 0.5
|
0.25 units on a scale
Interval -1.25 to 1.5
|
0.75 units on a scale
Interval 0.0 to 1.5
|
SECONDARY outcome
Timeframe: From baseline to 1 week and from baseline to 1 monthQuality of Life (McGill Total); Mean of five sub-measures (but not overall) (0 = negative to 10 = positive)
Outcome measures
| Measure |
Massage
n=20 Participants
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
|
No-touch Control
n=10 Participants
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
|
Usual Care
n=9 Participants
Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
|
|---|---|---|---|
|
Quality of Life: McGill Total
1 week
|
0.45 units on a scale
Interval 0.0 to 1.23
|
0 units on a scale
Interval -0.66 to 0.28
|
0 units on a scale
Interval -0.57 to 0.0
|
|
Quality of Life: McGill Total
1 month
|
0 units on a scale
Interval -0.42 to 0.3
|
-0.18 units on a scale
Interval -1.29 to 0.13
|
0 units on a scale
Interval 0.0 to 0.58
|
SECONDARY outcome
Timeframe: From baseline to 1 week and from baseline to 1 monthSleep (Richards-Campbell) 0 = best sleep to 50 = worst sleep
Outcome measures
| Measure |
Massage
n=20 Participants
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
|
No-touch Control
n=10 Participants
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
|
Usual Care
n=9 Participants
Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
|
|---|---|---|---|
|
Sleep
1 month
|
-4 units on a scale
Interval -12.0 to 0.0
|
0 units on a scale
Interval -12.0 to 10.0
|
0 units on a scale
Interval -15.0 to 12.0
|
|
Sleep
1 week
|
-3.5 units on a scale
Interval -9.0 to 0.0
|
0 units on a scale
Interval -7.0 to 9.0
|
-0.5 units on a scale
Interval -4.0 to 1.0
|
Adverse Events
Massage
No-touch Control
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Russell S. Phillips, MD
Beth Israel Deaconess Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place