Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082290
Status:
COMPLETED
Last Update Posted:
2015-12-18
First Post:
2004-05-05
Brief Title:
Massage Therapy in Treating Patients With Cancer Pain
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Massage for the Treatment of Pain in Cancer A Randomized Phase II Study
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None