A randomised controlled trial of the effects of reflexology on mood, coping and quality of life in women with early breast cancer

ISRCTN	ISRCTN87652313
DOI	https://doi.org/10.1186/ISRCTN87652313
Secondary identifying numbers	NCP2/X229

Submission date: 12/09/2005
Registration date: 03/11/2005
Last edited: 09/05/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Leslie G Walker
Scientific

Institute of Rehabilitation
University of Hull
215 Anlaby Rd
KIngston upon Hull
HU3 2PG
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	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
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Early breast cancer.
Intervention	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)
Intervention type	Other
Primary outcome measure	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 measures	1. Mood Rating Scale (MRS) 2. Patient Satisfaction Questionnaire (PSQ) 3. FACT-B at week 24
Overall study start date	01/04/2002
Completion date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	180
Key inclusion criteria	Newly diagnosed early breast cancer (T1, T2 <3 cm, N0, N1a, M0).
Key exclusion criteria	1. Unable to complete the study questionnaires 2. Unwilling to give written informed consent
Date of first enrolment	01/04/2002
Date of final enrolment	31/12/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute of Rehabilitation

KIngston upon Hull
HU3 2PG
United Kingdom

Sponsor information

NHS Research and Development National Cancer Programme (UK)
Government

Dr H Campbell
Peninsula Medical School
Haighton Building
St Luke's Campus
Exeter
EX1 2LU
United Kingdom

Phone	+44(0)1392 262 929
Email	h.e.bailey@exeter.ac.uk
Website	http://www.exeter.ac.uk/shhs/canc

Funders

Funder type

Government

NHS R&D National Cancer Programme

No information available

NCP/X229.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2010		Yes	No