Condition category
Cancer
Date applied
12/09/2005
Date assigned
03/11/2005
Last edited
09/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Leslie G Walker

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NCP2/X229

Study information

Scientific title

Acronym

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

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/04/2002

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Newly diagnosed early breast cancer (T1, T2 <3 cm, N0, N1a, M0).

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

180

Participant exclusion criteria

1. Unable to complete the study questionnaires
2. Unwilling to give written informed consent

Recruitment start date

01/04/2002

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Rehabilitation
KIngston upon Hull
HU3 2PG
United Kingdom

Sponsor information

Organisation

NHS Research and Development National Cancer Programme (UK)

Sponsor details

Dr H Campbell
Peninsula Medical School
Haighton Building
St Luke's Campus
Exeter
EX1 2LU
United Kingdom
+44(0)1392 262 929
h.e.bailey@exeter.ac.uk

Sponsor type

Government

Website

http://www.exeter.ac.uk/shhs/canc

Funders

Funder type

Government

Funder name

NHS R&D National Cancer Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NCP/X229.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19906525

Publication citations

  1. Results

    Sharp DM, Walker MB, Chaturvedi A, Upadhyay S, Hamid A, Walker AA, Bateman JS, Braid F, Ellwood K, Hebblewhite C, Hope T, Lines M, Walker LG, A randomised, controlled trial of the psychological effects of reflexology in early breast cancer., Eur. J. Cancer, 2010, 46, 2, 312-322, doi: 10.1016/j.ejca.2009.10.006.

Additional files

Editorial Notes