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 |
| Protocol serial number | NCP2/X229 |
| Sponsor | NHS Research and Development National Cancer Programme (UK) |
| Funders | NHS R&D National Cancer Programme, NCP/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
Scientific
Institute of Rehabilitation
University of Hull
215 Anlaby Rd
KIngston upon Hull
HU3 2PG
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(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. |
| Key secondary outcome measure(s) |
1. Mood Rating Scale (MRS) |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Institute of Rehabilitation
KIngston upon Hull
HU3 2PG
United Kingdom
HU3 2PG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
