Reflexology or Aromatherapy Massage in Relieving Symptoms in Patients With Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01217424
First received: October 7, 2010
Last updated: August 23, 2013
Last verified: October 2010
  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?

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217424

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   
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
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: August 23, 2013
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 August 20, 2014