Reflexology or Aromatherapy Massage in Relieving Symptoms in Patients With Cancer
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pain 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 Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2010 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| Royal Marsden - London | Recruiting |
| London, England, United Kingdom, SW3 6JJ | |
| Contact: Contact Person 44-20-7808-2819 clare.shaw@rmh.nhs.uk | |
| Principal Investigator: | Clare Shaw, MD | Royal Marsden NHS Foundation Trust |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT01217424 History of Changes |
| Other Study ID Numbers: | CDR0000686459, RMNHS-REFLEXOLOGY, EU-21075, MREC-10/H0801/31 |
| Study First Received: | October 7, 2010 |
| Last Updated: | October 7, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
psychosocial effects of cancer and its treatment pain unspecified adult solid tumor, protocol specific |
ClinicalTrials.gov processed this record on May 16, 2013