Cancer
Conditions
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
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.
Interventions
PROCEDUREmanagement of therapy complications
PROCEDUREmassage therapy
PROCEDUREpain therapy
PROCEDUREpsychosocial assessment and care
PROCEDUREquality-of-life assessment
Sponsors
National Cancer Institute (NCI)
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
The study was designed to assess the feasibility and effectiveness of massage for patients with cancer-related pain
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | From baseline to 1 week and from baseline to one month | 0=no pain to 10=most severe pain |
| Anxiety | From baseline to 1 week and from baseline to 1 month | 0=no anxiety to 10=most severe anxiety |
| Alertness | From baseline to 1 week and from baseline to 1 month | 0=not at all alert to 10=most alert |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep | From baseline to 1 week and from baseline to 1 month | Sleep (Richards-Campbell) 0 = best sleep to 50 = worst sleep |
| Quality of Life: Psychological Well-being | 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) |
| Quality of Life: McGill Total | 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) |
| Quality of Life: Physical Well-being | 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) |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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 | 10 |
| 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 | 9 |
| Total | 39 |
Baseline characteristics
| Characteristic | No-touch Control | Massage | Usual Care | Total |
|---|---|---|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 10 | 54.9 years STANDARD_DEVIATION 12 | 55.6 years STANDARD_DEVIATION 9 | 55.1 years STANDARD_DEVIATION 11 |
| Education: College grad or more | 6 Participants | 10 Participants | 5 Participants | 21 Participants |
| Employment: full-time or part-time | 5 Participants | 5 Participants | 4 Participants | 14 Participants |
| Household income: Not available/refused/don't know, <$50,000, >$50,000 <$50,000 | 2 Participants | 4 Participants | 1 Participants | 7 Participants |
| Household income: Not available/refused/don't know, <$50,000, >$50,000 >$50,000 | 5 Participants | 13 Participants | 7 Participants | 25 Participants |
| Household income: Not available/refused/don't know, <$50,000, >$50,000 Not available/refused/Don't know | 3 Participants | 3 Participants | 1 Participants | 7 Participants |
| Living alone | 2 Participants | 3 Participants | 0 Participants | 5 Participants |
| Marital status: Married, Other Married | 6 Participants | 13 Participants | 8 Participants | 27 Participants |
| Marital status: Married, Other Other | 4 Participants | 7 Participants | 1 Participants | 12 Participants |
| Not admitted to hospital in the last 12 months | 6 Participants | 8 Participants | 4 Participants | 18 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 9 Participants | 19 Participants | 8 Participants | 36 Participants |
| Sex: Female, Male Female | 9 Participants | 17 Participants | 6 Participants | 32 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 10 | 1 / 9 |
| other Total, other adverse events | 0 / 20 | 0 / 10 | 0 / 9 |
| serious Total, serious adverse events | 0 / 20 | 0 / 10 | 0 / 9 |
Outcome results
Primary
Alertness
0=not at all alert to 10=most alert
Time frame: From baseline to 1 week and from baseline to 1 month
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Massage | Alertness | 1 week | 0 units on a scale |
| Massage | Alertness | 1 month | 0 units on a scale |
| No-touch Control | Alertness | 1 week | 0 units on a scale |
| No-touch Control | Alertness | 1 month | 0 units on a scale |
| Usual Care | Alertness | 1 week | 1 units on a scale |
| Usual Care | Alertness | 1 month | 0 units on a scale |
Primary
Anxiety
0=no anxiety to 10=most severe anxiety
Time frame: From baseline to 1 week and from baseline to 1 month
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Massage | Anxiety | 1 week | 0 units on a scale |
| Massage | Anxiety | 1 month | 0 units on a scale |
| No-touch Control | Anxiety | 1 week | 0 units on a scale |
| No-touch Control | Anxiety | 1 month | 0 units on a scale |
| Usual Care | Anxiety | 1 week | 0 units on a scale |
| Usual Care | Anxiety | 1 month | 0 units on a scale |
Primary
Pain
0=no pain to 10=most severe pain
Time frame: From baseline to 1 week and from baseline to one month
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Massage | Pain | 1 week | 0 units on a scale |
| Massage | Pain | 1 month | 0 units on a scale |
| No-touch Control | Pain | 1 week | 0 units on a scale |
| No-touch Control | Pain | 1 month | 0 units on a scale |
| Usual Care | Pain | 1 week | 0 units on a scale |
| Usual Care | Pain | 1 month | -2 units on a scale |
Secondary
Quality of Life: McGill Total
Quality of Life (McGill Total); Mean of five sub-measures (but not overall) (0 = negative to 10 = positive)
Time frame: From baseline to 1 week and from baseline to 1 month
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Massage | Quality of Life: McGill Total | 1 week | 0.45 units on a scale |
| Massage | Quality of Life: McGill Total | 1 month | 0 units on a scale |
| No-touch Control | Quality of Life: McGill Total | 1 week | 0 units on a scale |
| No-touch Control | Quality of Life: McGill Total | 1 month | -0.18 units on a scale |
| Usual Care | Quality of Life: McGill Total | 1 week | 0 units on a scale |
| Usual Care | Quality of Life: McGill Total | 1 month | 0 units on a scale |
Secondary
Quality of Life: Physical Well-being
Physical well-being over past 2 days (0= physically terrible to 10= physically well)
Time frame: From baseline to 1 week and from baseline to 1 month
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Massage | Quality of Life: Physical Well-being | 1 week | 1 units on a scale |
| Massage | Quality of Life: Physical Well-being | 1 month | 0 units on a scale |
| No-touch Control | Quality of Life: Physical Well-being | 1 week | -0.5 units on a scale |
| No-touch Control | Quality of Life: Physical Well-being | 1 month | 0 units on a scale |
| Usual Care | Quality of Life: Physical Well-being | 1 week | 0 units on a scale |
| Usual Care | Quality of Life: Physical Well-being | 1 month | 0 units on a scale |
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)
Time frame: From baseline to 1 week and from baseline to 1 month
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Massage | Quality of Life: Psychological Well-being | 1 week | 1.125 units on a scale |
| Massage | Quality of Life: Psychological Well-being | 1 month | -0.125 units on a scale |
| No-touch Control | Quality of Life: Psychological Well-being | 1 week | 0.25 units on a scale |
| No-touch Control | Quality of Life: Psychological Well-being | 1 month | 0.25 units on a scale |
| Usual Care | Quality of Life: Psychological Well-being | 1 week | 0 units on a scale |
| Usual Care | Quality of Life: Psychological Well-being | 1 month | 0.75 units on a scale |
Secondary
Sleep
Sleep (Richards-Campbell) 0 = best sleep to 50 = worst sleep
Time frame: From baseline to 1 week and from baseline to 1 month
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Massage | Sleep | 1 week | -3.5 units on a scale |
| Massage | Sleep | 1 month | -4 units on a scale |
| No-touch Control | Sleep | 1 week | 0 units on a scale |
| No-touch Control | Sleep | 1 month | 0 units on a scale |
| Usual Care | Sleep | 1 week | -0.5 units on a scale |
| Usual Care | Sleep | 1 month | 0 units on a scale |