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A randomised controlled trial of the effects of reflexology on mood, coping and quality of life in women with early breast cancer
DOI 10.1186/ISRCTN87652313
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised controlled trial of the effects of reflexology on mood, coping and quality of life in women with early breast cancer
Scientific title
Acronym N/A
Serial number at source NCP2/X229
Study hypothesis 1. Reflexology will be superior to a comparator contact intervention (massage) and treatment as usual (self-initiated support) in terms of its effect on quality of life
2. Reflexology will be acceptable to patients with early breast cancer as manifest by high levels of patient satisfaction and a high uptake of reflexology sessions
3. Reflexology will enhance perceived self control of health
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Early breast cancer.
Participants - inclusion criteria Newly diagnosed early breast cancer (T1, T2 <3 cm, N0, N1a, M0).
Participants - exclusion criteria 1. Unable to complete the study questionnaires
2. Unwilling to give written informed consent
Anticipated start date 01/04/2002
Anticipated end date 31/12/2005
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 180
Interventions Intervention 1: self-initiated support in the Oncology Health Centres (treatment as usual)

Intervention 2: self-initiated support in the Oncology Health Centres plus scalp massage (comparator physical and social contact intervention)

Intervention 3: self-initiated support in the Oncology Health Centres plus reflexology (a standard foot reflexology routine)
Primary outcome measure(s) The primary outcome measures will be patient acceptability (number of sessions of reflexology actually attended) and scores on the Clinical Trials Index derived from the Functional Assessment of Cancer Therapy: Breast Version (FACT-B) at week 18.
Secondary outcome measure(s) 1. Mood Rating Scale (MRS)
2. Patient Satisfaction Questionnaire (PSQ)
3. FACT-B at week 24
Sources of funding NHS R&D National Cancer Programme
Trial website
Publications 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19906525
Contact name Prof  Leslie G  Walker
  Address Institute of Rehabilitation
University of Hull
215 Anlaby Rd
  City/town KIngston upon Hull
  Zip/Postcode HU3 2PG
  Country United Kingdom
Sponsor NHS Research and Development National Cancer Programme (UK)
  Address Dr H Campbell
Peninsula Medical School
Haighton Building
St Luke's Campus
  City/town Exeter
  Zip/Postcode EX1 2LU
  Country United Kingdom
  Tel +44(0)1392 262 929
  Email h.e.bailey@exeter.ac.uk
  Sponsor website: http://www.exeter.ac.uk/shhs/canc
Date applied 12/09/2005
Last edited 09/05/2012
Date ISRCTN assigned 03/11/2005
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