NCT00065195

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
440

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2003

Typical duration for phase_2

Geographic Reach
1 country

9 active sites

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

First Submitted

Initial submission to the registry

July 18, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2003

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 25, 2008

Status Verified

January 1, 2008

Enrollment Period

3.3 years

First QC Date

July 18, 2003

Last Update Submit

January 23, 2008

Conditions

NeoplasmsPain

Keywords

MassagePalliative CareHospicesCancer

Outcome Measures

Primary Outcomes (1)

  • Decreased pain

Secondary Outcomes (4)

  • Less total analgesic medication use.

  • Improved quality of life

  • Decreased physical symptom distress

  • Decreased emotional symptom distress

Interventions

Moving touch therapyPROCEDURE
Nonmoving touch therapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced cancer, with at least moderate pain 1 week prior to study entry
  • Life expectancy of at least 3 weeks
  • Able to speak English

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

San Diego Hospice

San Diego, California, 92103, United States

Location

Pike's Peak Hospice and Palliative Care

Colorado Springs, Colorado, 80903, United States

Location

Pathways at Hospice of Metro Denver

Denver, Colorado, 80246, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80262, United States

Location

Hospice of St. John

Lakewood, Colorado, 80215, United States

Location

Hope Hospice and Palliative Care

Fort Myers, Florida, 33908, United States

Location

LifePath Hospice and Palliative Care, Inc.

Tampa, Florida, 33609, United States

Location

Hospice Care in the Berkshires, Inc.

Pittsfield, Massachusetts, 01201, United States

Location

Hospice at Charlotte

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

NeoplasmsPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean S. Kutner, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

  • Marlaine Smith, RN, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 18, 2003

First Posted

July 21, 2003

Study Start

November 1, 2003

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

January 25, 2008

Record last verified: 2008-01

Locations

US(9)