Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2026-01-02 @ 11:02 AM
Study NCT ID:
NCT00065195
Status:
COMPLETED
Last Update Posted:
2008-01-25
First Post:
2003-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REST: Reducing End-of-Life Symptoms With Touch
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 440}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-23', 'studyFirstSubmitDate': '2003-07-18', 'studyFirstSubmitQcDate': '2003-07-18', 'lastUpdatePostDateStruct': {'date': '2008-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decreased pain'}], 'secondaryOutcomes': [{'measure': 'Less total analgesic medication use.'}, {'measure': 'Improved quality of life'}, {'measure': 'Decreased physical symptom distress'}, {'measure': 'Decreased emotional symptom distress'}]}, 'conditionsModule': {'keywords': ['Massage', 'Palliative Care', 'Hospices', 'Cancer'], 'conditions': ['Neoplasms', 'Pain']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced cancer, with at least moderate pain 1 week prior to study entry\n* Life expectancy of at least 3 weeks\n* Able to speak English\n\nExclusion Criteria:\n\n* Massage therapy within 1 month prior to study entry\n* Current use of anticoagulants\n* Platelet count less than 10,000\n* Unstable spine that would interfere with touch therapy'}, 'identificationModule': {'nctId': 'NCT00065195', 'briefTitle': 'REST: Reducing End-of-Life Symptoms With Touch', 'organization': {'class': 'NIH', 'fullName': 'National Center for Complementary and Integrative Health (NCCIH)'}, 'officialTitle': 'Efficacy of Massage at the End of Life', 'orgStudyIdInfo': {'id': 'R01AT001006-01A2', 'link': 'https://reporter.nih.gov/quickSearch/R01AT001006-01A2', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Moving touch therapy', 'type': 'PROCEDURE'}, {'name': 'Nonmoving touch therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Hospice', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80903', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': "Pike's Peak Hospice and Palliative Care", 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80246', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Pathways at Hospice of Metro Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80215', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Hospice of St. John', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '33908', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Hope Hospice and Palliative Care', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'LifePath Hospice and Palliative Care, Inc.', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '01201', 'city': 'Pittsfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Hospice Care in the Berkshires, Inc.', 'geoPoint': {'lat': 42.45008, 'lon': -73.24538}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Hospice at Charlotte', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Jean S. Kutner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Marlaine Smith, RN, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}}}}