CancerNCT00253708

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

A study testing management of therapy complications, massage therapy and pain therapy in people with Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 120 years
Conditions the study is for: Cancer
What is being tested?: management of therapy complications, massage therapy and pain therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2004to 1 Jan 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 120 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Solid cancer with evidence of metastases
Receiving treatment at Beth Israel Deaconess Medical Center (BIDMC)
Must reside ≤ 25 miles from BIDMC

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Body-Based Complementary Therapies for Patients With Cancer

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.

Read the 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.

Conditions: Cancer
Being tested: management of therapy complications, massage therapy, pain therapy, psychosocial assessment and care, quality-of-life assessment
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
Medical subject headings: Neoplasms, Depression, Nausea, Vomiting, Pain, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

management of therapy complicationsProcedure or surgery
massage therapyProcedure or surgery
pain therapyProcedure or surgery
psychosocial assessment and careProcedure or surgery
quality-of-life assessmentProcedure or surgery

Study groups in NCT00253708
Study group	Role	What they receive
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 Receives: Procedure: management of therapy complications; Procedure: massage therapy; Procedure: pain therapy; Procedure: psychosocial assessment and care; Procedure: 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 Receives: Procedure: management of therapy complications; Procedure: massage therapy; Procedure: pain therapy; Procedure: psychosocial assessment and care; Procedure: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain
0=no pain to 10=most severe pain
Measured: From baseline to 1 week and from baseline to one month
Anxiety
0=no anxiety to 10=most severe anxiety
Measured: From baseline to 1 week and from baseline to 1 month
Alertness
0=not at all alert to 10=most alert
Measured: From baseline to 1 week and from baseline to 1 month

Secondary outcomes (4)

Quality of Life: Physical Well-being
Physical well-being over past 2 days (0= physically terrible to 10= physically well)
Measured: From baseline to 1 week and from baseline to 1 month
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)
Measured: 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)
Measured: From baseline to 1 week and from baseline to 1 month
Sleep
Sleep (Richards-Campbell) 0 = best sleep to 50 = worst sleep
Measured: From baseline to 1 week and from baseline to 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20041 Jan 2013

First posted15 Nov 2005 (estimated)
Study start1 Dec 2004
Primary completion1 Jan 2013
Study completion1 Jan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CancerStudies of the same condition, open and under way.
More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: The study was designed to assess the feasibility and effectiveness of massage for patients with cancer-related pain
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00253708
Sponsor's protocol ID: 2003P000299
Other IDs: CDR0000445117, R21CA098487
Status last verified: Jun 2017
First submitted: 11 Nov 2005
Last updated: 7 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 23368724

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Body-Based Complementary Therapies for Patients With Cancer
ClinicalTrials.gov ID: NCT00253708
Acronym / sponsor ID: 2003P000299
Conditions: Cancer
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Beth Israel Deaconess Medical CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 1 Dec 2004 (actual)
Primary completion: 1 Jan 2013 (actual)
Study completion: 1 Jan 2013 (actual)
First posted: 15 Nov 2005 (estimated)
Results: Posted 7 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3
Model description: The study was designed to assess the feasibility and effectiveness of massage for patients with cancer-related pain

Arm	Type	Receives
massage	Experimental	Procedure: management of therapy complications, Procedure: massage therapy, Procedure: pain therapy, Procedure: psychosocial assessment and care, Procedure: quality-of-life assessmentPatients 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	Procedure: management of therapy complications, Procedure: massage therapy, Procedure: pain therapy, Procedure: psychosocial assessment and care, Procedure: quality-of-life assessmentPatients 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

Who may qualify

Ages: 18 to 120 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Solid cancer with evidence of metastases
Receiving treatment at Beth Israel Deaconess Medical Center (BIDMC)
Must reside ≤ 25 miles from BIDMC

Key exclusion criteria (6 listed)

Patient to sick to be interviewed
Absence of severe symptoms
Participating in another trial
Language barrier
MD does not provide permission

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
management of therapy complications	Procedure or surgery	massage, no-touch control
massage therapy	Procedure or surgery	massage, no-touch control
pain therapy	Procedure or surgery	massage, no-touch control
psychosocial assessment and care	Procedure or surgery	massage, no-touch control
quality-of-life assessment	Procedure or surgery	massage, no-touch control

Primary outcome

Pain
Time frame: From baseline to 1 week and from baseline to one month
0=no pain to 10=most severe pain
Anxiety
Time frame: From baseline to 1 week and from baseline to 1 month
0=no anxiety to 10=most severe anxiety
Alertness
Time frame: From baseline to 1 week and from baseline to 1 month
0=not at all alert to 10=most alert

4 secondary outcomes

Quality of Life: Physical Well-being
Time frame: From baseline to 1 week and from baseline to 1 month
Quality of Life: Psychological Well-being
Time frame: From baseline to 1 week and from baseline to 1 month
Quality of Life: McGill Total
Time frame: From baseline to 1 week and from baseline to 1 month
Sleep
Time frame: From baseline to 1 week and from baseline to 1 month

Results and safety

Results posted to the registry on 7 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Touch Intervention (Massage Therapy)	20	20
No Touch Intervention (Control)	10	10
Usual Care (Control)	9	8

Primary outcome: Pain

Time frame: From baseline to 1 week and from baseline to one month. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Massage n = 20	No-touch Control n = 10	Usual Care n = 9
1 week	0 (-2 to 1)	0 (-1 to 2)	0 (-3 to 2)
1 month	0 (-1 to 0)	0 (-1.5 to 0)	-2 (-2 to -1)

Primary outcome: Anxiety

Time frame: From baseline to 1 week and from baseline to 1 month. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Massage n = 20	No-touch Control n = 10	Usual Care n = 9
1 week	0 (-3 to 0)	0 (-3 to 0)	0 (-2 to 0)
1 month	0 (-2 to 0)	0 (-1.5 to 1)	0 (-3 to 0)

Primary outcome: Alertness

Time frame: From baseline to 1 week and from baseline to 1 month. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Massage n = 20	No-touch Control n = 10	Usual Care n = 9
1 week	0 (0 to 0)	0 (-0.5 to 0)	1 (0 to 2)
1 month	0 (-1 to 0)	0 (-1.5 to 0)	0 (0 to 1)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline to 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Massage	0 of 20 (0%)	0 of 20 (0%)	0 of 20
No-touch Control	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Usual Care	0 of 9 (0%)	0 of 9 (0%)	1 of 9

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23368724Toth 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Russell S. Phillips, MD principal investigator

Beth Israel Deaconess Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing management of therapy complications, massage therapy and pain therapy in people with Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain (time frame: From baseline to 1 week and from baseline to one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00253708, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2017.