Reflexology or Aromatherapy Massage in Relieving Symptoms in Patients With Cancer
Recruitment status was Recruiting
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.
Psychosocial Effects of Cancer and Its Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Other: questionnaire administration
Procedure: aromatherapy and essential oils
Procedure: management of therapy complications
Procedure: massage therapy
Procedure: psychosocial assessment and care
Procedure: reflexology procedure
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||Is Reflexology as Effective as Aromatherapy Massage for Symptom Relief in an Outpatient Oncology Population?|
- 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) [ Designated as safety issue: No ]
- Difference of 2 points of concern scores in MYCAW questionnaire [ Designated as safety issue: No ]
- Difference in MYCAW overall well-being score [ Designated as safety issue: No ]
- Change over time in pre-session Visual Analogue Scale (VAS) relaxation score (long-term relaxation benefit) [ Designated as safety issue: No ]
- Change in pre- to post-session VAS relaxation score (short-term relaxation benefit) [ Designated as safety issue: No ]
- Percentage of patients gaining benefit from the intervention defined as improvement by at least 1 point in all answered MYCAW scales [ Designated as safety issue: No ]
|Study Start Date:||October 2010|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
- To determine whether reflexology is as effective as aromatherapy massage for alleviation of self-selected symptoms in patients with cancer in an outpatient setting.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01217424
|Royal Marsden - London||Recruiting|
|London, England, United Kingdom, SW3 6JJ|
|Contact: Contact Person 44-20-7808-2819 firstname.lastname@example.org|
|Principal Investigator:||Clare Shaw, MD||Royal Marsden NHS Foundation Trust|