NeoplasmsPhase 2NCT00065195
REST: Reducing End-of-Life Symptoms With Touch
A Phase 2 study testing Moving touch therapy and Nonmoving touch therapy in people with Neoplasms and Pain, run by National Center for Complementary and Integrative Health (NCCIH) at 9 sites in United States.
Trial summary
The purpose of this study is to determine whether massage therapy is effective in reducing pain and distress and improving quality of life among cancer patients at life's end. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Moving touch therapy and Nonmoving touch therapy
- Type of treatment
- Surgery or procedure
- How many people
- 440 participants
- Where
- 9 sitesUnited States
- Study dates
- Nov 2003to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced cancer, with at least moderate pain 1 week prior to study entry
- Life expectancy of at least 3 weeks
- Able to speak English
Who cannot join
- Massage therapy within 1 month prior to study entry
- Current use of anticoagulants
- Platelet count less than 10,000
- Unstable spine that would interfere with touch therapy
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Hospice at Charlotte
Charlotte, North Carolina, 28204
Pike's Peak Hospice and Palliative Care
Colorado Springs, Colorado, 80903
Pathways at Hospice of Metro Denver
Denver, Colorado, 80246
University of Colorado Cancer Center
Denver, Colorado, 80262
Hope Hospice and Palliative Care
Fort Myers, Florida, 33908
Hospice of St. John
Lakewood, Colorado, 80215
Hospice Care in the Berkshires, Inc.
Pittsfield, Massachusetts, 01201
San Diego Hospice
San Diego, California, 92103
LifePath Hospice and Palliative Care, Inc.
Tampa, Florida, 33609
About this study
Official title: Efficacy of Massage at the End of Life
The purpose of this study is to determine whether massage therapy is effective in reducing pain and distress and improving quality of life among cancer patients at life's end.
Read the detailed description
Relieving physical and emotional symptoms is a key component of end-of-life care. Despite care, terminally ill patients are still significantly burdened by unrelieved symptoms. Therapies that have potential to alleviate these symptoms deserve thorough investigation.
This study will last 3 weeks. Participants in this study will be randomly assigned to receive six sessions of either moving or nonmoving touch therapy, in addition to usual hospice care, for 2 weeks. Moving touch therapy consists of massage therapy in which a trained therapist continually touches a person's body. The nonmoving touch therapy will be conducted by volunteers who have no previous experience in massage. Participants in this group will have a volunteer rub specific body parts for 3-minute intervals. Because current evidence suggests that thoughts of healing may influence the effectiveness of touch therapy, volunteers in the nonmoving therapy group will distract their minds to avoid thinking of healing processes. In both groups, the person administering the touch therapy will note all interruptions during a session, including talk, music, and television. Interviews about medication use, pain, and quality of life will be used to assess participants; these interviews will be conducted at study start, immediately before and after each therapy session, and at Weeks 1, 2, and 3.
- Being tested
- Moving touch therapy, Nonmoving touch therapy
- Keywords
- Massage, Palliative Care, Hospices, Cancer
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moving touch therapyProcedure or surgery
Nonmoving touch therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased pain
Secondary outcomes (4)
Less total analgesic medication use.
Improved quality of life
Decreased physical symptom distress
Decreased emotional symptom distress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2003 (estimated)
- Study startNov 2003
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 440 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jean S. Kutner, MD, Principal investigator, University of Colorado, DenverMarlaine Smith, RN, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065195
- Sponsor's protocol ID
- R01AT001006-01A2
- Status last verified
- Jan 2008
- First submitted
- 18 Jul 2003
- Last updated
- 25 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Massage at the End of Life
- ClinicalTrials.gov ID
- NCT00065195
- Acronym / sponsor ID
- R01AT001006-01A2
- Keywords
- Massage, Palliative Care, Hospices, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Nov 2003
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 21 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether massage therapy is effective in reducing pain and distress and improving quality of life among cancer patients at life's end.
Detailed description
Relieving physical and emotional symptoms is a key component of end-of-life care. Despite care, terminally ill patients are still significantly burdened by unrelieved symptoms. Therapies that have potential to alleviate these symptoms deserve thorough investigation.
This study will last 3 weeks. Participants in this study will be randomly assigned to receive six sessions of either moving or nonmoving touch therapy, in addition to usual hospice care, for 2 weeks. Moving touch therapy consists of massage therapy in which a trained therapist continually touches a person's body. The nonmoving touch therapy will be conducted by volunteers who have no previous experience in massage. Participants in this group will have a volunteer rub specific body parts for 3-minute intervals. Because current evidence suggests that thoughts of healing may influence the effectiveness of touch therapy, volunteers in the nonmoving therapy group will distract their minds to avoid thinking of healing processes. In both groups, the person administering the touch therapy will note all interruptions during a session, including talk, music, and television. Interviews about medication use, pain, and quality of life will be used to assess participants; these interviews will be conducted at study start, immediately before and after each therapy session, and at Weeks 1, 2, and 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Advanced cancer, with at least moderate pain 1 week prior to study entry
- Life expectancy of at least 3 weeks
- Able to speak English
Key exclusion criteria (4 listed)
- Massage therapy within 1 month prior to study entry
- Current use of anticoagulants
- Platelet count less than 10,000
- Unstable spine that would interfere with touch therapy
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 |
|---|---|---|
| Moving touch therapy | Procedure or surgery | – |
| Nonmoving touch therapy | Procedure or surgery | – |
Primary outcome
Decreased pain
4 secondary outcomes
Less total analgesic medication use.
Improved quality of life
Decreased physical symptom distress
Decreased emotional symptom distress
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2008.
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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.
Jean S. Kutner, MD principal investigator
University of Colorado, Denver
Marlaine Smith, RN, PhD principal investigator
University of Colorado, Denver
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Moving touch therapy and Nonmoving touch therapy in people with Neoplasms and Pain, run by National Center for Complementary and Integrative Health (NCCIH) at 9 sites 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 4 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 25 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Decreased pain. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2008.