NCT00082290

Brief Summary

RATIONALE: Massage therapy may help lessen pain caused by cancer. PURPOSE: This randomized phase II trial is studying how well massage therapy works in treating patients with cancer pain.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_2 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 5, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2004

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

7.8 years

First QC Date

May 5, 2004

Last Update Submit

December 17, 2015

Conditions

PainUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificpain

Outcome Measures

Primary Outcomes (1)

  • reduction in pain

    A mean change score equivalent to 2 points will be considered the minimum clinically significant reduction in pain

    24 hours after treatment

Study Arms (3)

a massage

EXPERIMENTAL

About 45 minute massage

Other: massage therapyBehavioral: questionaire about pain

visit with a volunteer

EXPERIMENTAL

45 minute visit

Other: visit with a volunteerBehavioral: questionaire about pain

period of quiet time

EXPERIMENTAL

45 minutes of quiet time

Other: period of quiet timeBehavioral: questionaire about pain

Interventions

massage therapyOTHER
a massage
visit with a volunteerOTHER
visit with a volunteer
period of quiet timeOTHER
period of quiet time
questionaire about painBEHAVIORAL
a massageperiod of quiet timevisit with a volunteer

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of cancer * Baseline pain score ≥ 2 on a 0-10 rating scale where 0 = no pain * Pain syndrome must be the result of cancer and/or cancer treatment * No postoperative or other acute procedural pain PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Concurrent pharmacologic pain therapy allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Barrie R. Cassileth, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2004

First Posted

May 6, 2004

Study Start

May 1, 2003

Primary Completion

February 1, 2011

Last Updated

December 18, 2015

Record last verified: 2015-12

Locations

US(1)