Reflexology or Aromatherapy Massage in Relieving Symptoms in Patients With Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Is Reflexology as Effective as Aromatherapy Massage for Symptom Relief in an Outpatient Oncology Population?

Conditions
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Pain, Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Other: questionnaire administration
* Procedure: aromatherapy and essential oils
* Procedure: management of therapy complications
* Procedure: massage therapy
* Procedure: psychosocial assessment and care
* Procedure: reflexology procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire administration|nan|
|Procedure: aromatherapy and essential oils|nan|
|Procedure: management of therapy complications|nan|
|Procedure: massage therapy|nan|
|Procedure: psychosocial assessment and care|nan|
|Procedure: reflexology procedure|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosocial effects of cancer and its treatment, pain, unspecified adult solid tumor, protocol specific