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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

From baseline to 1 week and from baseline to one month

Results posted on

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

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

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 month

0=no pain to 10=most severe pain

Outcome measures

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 month

0=no anxiety to 10=most severe anxiety

Outcome measures

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 month

0=not at all alert to 10=most alert

Outcome measures

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 month

Physical well-being over past 2 days (0= physically terrible to 10= physically well)

Outcome measures

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 month

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)

Outcome measures

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 month

Quality of Life (McGill Total); Mean of five sub-measures (but not overall) (0 = negative to 10 = positive)

Outcome measures

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 month

Sleep (Richards-Campbell) 0 = best sleep to 50 = worst sleep

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

No-touch Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Usual Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

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

Phone: 6174322222

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place