Observational study exploring treatment for women with arm lymphoedema.
Research type
Research Study
Full title
An observational study exploring treatment for women newly presenting with breast cancer-related upper limb lymphoedema.
IRAS ID
161289
Contact name
Eunice Jeffs
Contact email
Duration of Study in the UK
1 years, 2 months, 23 days
Research summary
Lymphoedema affects approximately 20% women following breast cancer treatment. Without effective treatment symptoms worsen, e.g. increased arm size, denser arm, increased infection risk, lymphoedema more visible to others, difficulty with daily activities. Current treatment is based on ‘best practice’, but we have no evidence for the most effective treatment to be given women when they first develop lymphoedema.
Before undertaking an effectiveness study we need to know whether it is possible to conduct such a study. For example: how many participants should we recruit? can we recruit and retain enough participants? which interventions and assessment tools are acceptable to patients and practitioners? what primary (main) outcome should we use to detect a difference between intervention and comparator groups? This study aims to answers these questions.
Participants will be women who developed lymphoedema symptoms within the previous 12 months but have not yet received treatment. They are recruited immediately following their first Lymphoedema Clinic appointment, and randomly allocated to one of two intervention groups or comparator group.
All participants are given ‘usual’ UK lymphoedema care. Intervention group participants receive 10 extra treatment sessions over 2 week period followed by ‘usual’ care. All treatment is provided by Lymphoedema Clinic staff.
Participants are in the study for maximum eleven months. In addition to Lymphoedema Clinic appointments, all participants are seen for assessment by the Investigator at one and three months (clinical measurements and self-report questionnaires). Anyone recruited prior to 1/10/16 is also assessed at six months. Some participants will be invited for a one hour interview to further explore their experience of participating in the study and satisfaction with treatment and perceived benefit.
Lymphoedema Practitioners treating study participants will be recruited to complete a self-report questionnaire regarding perceived treatment benefit and involvement in the study, and may be interviewed to further explore this.
REC name
London - Westminster Research Ethics Committee
REC reference
16/LO/0791
Date of REC Opinion
1 Jul 2016
REC opinion
Further Information Favourable Opinion