Reflexology or Aromatherapy Massage in Relieving Symptoms in Patients With Cancer

Not Applicable

Completed

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

• Registration Number: NCT01217424
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

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

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 Timeline

• Status Verified: 2010-10
• Study Start: 2010-10
• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-07
• Study First Posted: 2010-10-08
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Royal Marsden - London; 🇬🇧 London, England, United Kingdom