Massage Therapy in Treating Patients With Cancer Pain - Tabular View

Tracking Information

First Received Date ^ICMJE

May 5, 2004

Last Updated Date

July 22, 2009

Start Date ^ICMJE

May 2003

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Area-under-the-curve (AUC) pain for the first 24 hours after treatment [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Area-under-the-curve (AUC) pain for the first 24 hours after treatment

Change History

Complete list of historical versions of study NCT00082290 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Analgesics medication use in chronic pain patients as measured by the Medication Quantification Scale (MQS) every 24 hours [ Designated as safety issue: No ]
Duration of massage effects, patient gender, referral source, expectancy and associations between changes in levels of arousal and changes in pain scores [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Analgesics medication use in chronic pain patients as measured by the Medication Quantification Scale (MQS) every 24 hours
Duration of massage effects, patient gender, referral source, expectancy and associations between changes in levels of arousal and changes in pain scores

Descriptive Information

Brief Title ^ICMJE

Massage Therapy in Treating Patients With Cancer Pain

Official Title ^ICMJE

Massage for the Treatment of Pain in Cancer: A Randomized Phase II Study

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.

Detailed Description

OBJECTIVES:

Determine whether the effects of massage therapy in patients with cancer pain are sufficiently promising to warrant a definitive trial.
Determine the feasibility of a definitive trial.

OUTLINE: This is a randomized, controlled, pilot study. Patients are stratified according to in-patient status (yes vs no) and first baseline pain score ≥ 7 (yes vs no). Patients are randomized to 1 of 3 treatment arms.

Arm I (massage therapy): Patients receive a light touch ("Reiki") massage over 45 minutes.
Arm II (volunteer visit control): Patients receive a 45-minute visit from a trained volunteer who will be available to sit quietly or talk with the patient to discuss issues of concern, as desired by the patient. Volunteers will not touch the patient except to pat their shoulder or briefly hold their hand.
Arm III (quiet time control): Patients receive 45 minutes of quiet time. Pain and mood are assessed at baseline, immediately after treatment, at 6 hours and 24 hours after treatment, and then daily for the next 5 days after treatment.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Randomized, Active Control

Condition ^ICMJE

Pain
Unspecified Adult Solid Tumor, Protocol Specific

Intervention ^ICMJE

Procedure: massage therapy
Procedure: pain therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00082290

Responsible Party

Barrie R. Cassileth, Memorial Sloan-Kettering Cancer Center

Study ID Numbers ^ICMJE

CDR0000476652, MSKCC-03046A

Study Sponsor ^ICMJE

Memorial Sloan-Kettering Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Barrie R. Cassileth, PhD

Memorial Sloan-Kettering Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP