NCT01217424

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2010

Enrollment Period

1.1 years

First QC Date

October 7, 2010

Last Update Submit

October 31, 2016

Conditions

Keywords

psychosocial effects of cancer and its treatmentpainunspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Interventions

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Pain

Interventions

AromatherapyMassagePsychiatric RehabilitationMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and ActivitiesTherapy, Soft TissuePhysical Therapy ModalitiesRehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Clare Shaw, MD

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2010

First Posted

October 8, 2010

Study Start

October 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 1, 2016

Record last verified: 2010-10

Locations