Completed

Massage Therapy in Treating Patients With Cancer Pain

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What is being tested

massage therapy

+ visit with a volunteer
+ period of quiet time
Other
Behavioral
Who is being recruted

Pain

+ Unspecified Adult Solid Tumor, Protocol Specific
From 18 to 120 Years

See all eligibility criteria

How is the trial designed

Supportive Care Study

Phase 2
Interventional
Study Start: May 2003

See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: December 18, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2003Actual date on which the first participant was enrolled.

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. 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.

Official TitleMassage for the Treatment of Pain in Cancer: A Randomized Phase II Study 
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: December 18, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
92 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
About 45 minute massage
Group II
Experimental
45 minute visit
Group III
Experimental
45 minutes of quiet time
Study Objectives
Primary Objectives

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Memorial Sloan-Kettering Cancer CenterNew York, United StatesSee the location
CompletedOne Study Center