- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01217424
Reflexology or Aromatherapy Massage in Relieving Symptoms in Patients With Cancer
Is Reflexology as Effective as Aromatherapy Massage for Symptom Relief in an Outpatient Oncology Population?
RATIONALE: Reflexology and aromatherapy massage may lessen symptoms in patients with cancer. It is not yet known whether reflexology is more effective than aromatherapy massage in relieving symptoms in patients with cancer.
PURPOSE: This randomized clinical trial is studying reflexology to see how well it works compared with aromatherapy massage in relieving symptoms in patients with cancer.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
Primary
- To determine whether reflexology is as effective as aromatherapy massage for alleviation of self-selected symptoms in patients with cancer in an outpatient setting.
Secondary
- To determine the difference between the two therapies with respect to Visual Analogue Scale (VAS) relaxation scores before and after each treatment.
OUTLINE: Patients are stratified according to gender (male vs female), treatment (chemotherapy vs other) and their first concern choice (pain vs other). Patients are randomized to 1 of 2 intervention arms.
- Arm I (Reflexology): Patients undergo 45-60 minutes of reflexology for 4 sessions.
- Arm II (Aromatherapy massage): Patients undergo 45-60 minutes of of aromatherapy massage for 4 sessions.
Patients complete questionnaires (Measure Yourself Concerns and Well-being [MYCAW] questionnaire and Visual Analogue Scale [VAS]) at baseline, before and after each session, and after completion of all four sessions.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
England
-
London, England, United Kingdom, SW3 6JJ
- Royal Marsden - London
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Any patient receiving treatment for cancer at the Royal Marsden NHS Foundation Trust Hospital
- Must be attending the hospital as an outpatient
- Planning to access complementary therapy
PATIENT CHARACTERISTICS:
- No excessive pain in both hands and both feet
Not experiencing a combination of conditions affecting both hands and both feet which would prevent reflexology of either hands or feet from taking place, including any of the following:
- Deep vein thrombosis
- Lymphedema
- Infected or broken skin
- Recent scars or injuries
- Phlebitis
- Areas currently receiving radiotherapy (or received radiotherapy in the past 2 weeks)
- Able and willing to attend the hospital for four 1-hour sessions
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 2 months since prior and no other concurrent massage therapy or reflexology at the Royal Marsden NHS Foundation Trust Hospital or from another practitioner
- Not planning to undergo massage therapy or reflexology while also taking part in this study
- At least 2 months since prior and no other concurrent massage therapy at the Royal Marsden NHS Foundation Trust Hospital
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Difference of 1 point of concern scores in Measure Yourself Concerns and Well-being (MYCAW) questionnaire from baseline to second evaluation (after completion of all four sessions of therapy)
|
Secondary Outcome Measures
Outcome Measure |
---|
Difference of 2 points of concern scores in MYCAW questionnaire
|
Difference in MYCAW overall well-being score
|
Change over time in pre-session Visual Analogue Scale (VAS) relaxation score (long-term relaxation benefit)
|
Change in pre- to post-session VAS relaxation score (short-term relaxation benefit)
|
Percentage of patients gaining benefit from the intervention defined as improvement by at least 1 point in all answered MYCAW scales
|
Collaborators and Investigators
Investigators
- Principal Investigator: Clare Shaw, MD, Royal Marsden NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CDR0000686459
- RMNHS-REFLEXOLOGY
- EU-21075
- MREC-10/H0801/31
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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