Reflexology or Aromatherapy Massage in Relieving Symptoms in Patients With Cancer

NCT ID: NCT01217424

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

psychosocial effects of cancer and its treatment pain unspecified adult solid tumor, protocol specific

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

SUPPORTIVE_CARE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

questionnaire administration

Intervention Type OTHER

aromatherapy and essential oils

Intervention Type PROCEDURE

management of therapy complications

Intervention Type PROCEDURE

massage therapy

Intervention Type PROCEDURE

psychosocial assessment and care

Intervention Type PROCEDURE

reflexology procedure

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clare Shaw, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royal Marsden - London

London, England, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RMNHS-REFLEXOLOGY

Identifier Type: -

Identifier Source: secondary_id

EU-21075

Identifier Type: -

Identifier Source: secondary_id

MREC-10/H0801/31

Identifier Type: -

Identifier Source: secondary_id

CDR0000686459

Identifier Type: -

Identifier Source: org_study_id