REACT-CIPN Intervention Feasibility RCT Study
Research type
Research Study
Full title
REACT-CIPN Study: a feasibility randomised controlled trial with process evaluation of a co-designed intervention for chemotherapy-induced peripheral neuropathy
IRAS ID
297838
Contact name
Glenn Robert
Contact email
Sponsor organisation
King's College London
ISRCTN Number
ISRCTN10025993
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
Some cancer drugs can cause damage to nerves. Patients taking these drugs may develop a condition called Chemotherapy Induced Peripheral Neuropathy (or CIPN). The most common symptoms are felt in the hands and/or feet. Symptoms include tingling, pain and numbness. They can sometimes be severe enough to affect how patients are able use their hands and feet. Patients might be less mobile and less able to use their hands for detailed activities. Effective treatment for CIPN is limited and there is no certain way to prevent it. Sometimes chemotherapy doses can be delayed, reduced or discontinued in order to limit the seriousness of patients’ CIPN symptoms.
The REACT-CIPN patient information materials (booklet and film) were co-designed and co-developed by patients and staff. REACT-CIPN aims to:
- help patients to recognise symptoms early,
- encourage them to report their symptoms straightaway to clinical staff,
- help with making decisions about their ongoing treatment and
- offer strategies to help minimise the effects of CIPN in their daily activities.Our study aims to assess if it is possible to conduct a larger study to test the effectiveness of REACT-CIPN patient information materials. We also want to find out if the booklet and film are acceptable to patients and staff.
Patients will be recruited if they are at risk of developing CIPN due to chemotherapy treatment for bowel and breast cancer. Staff who give CIPN information to patients will also be recruited. Using an approach called randomisation, a computer will randomly assign patients to one of two possible methods of receiving CIPN information:
- standard care or
- REACT-CIPN patient information materials.All patient participants will be asked to complete questionnaires before treatment, midway and at the end of treatment. They will be invited for telephone interview at the end of their treatment.
REC name
London - Surrey Research Ethics Committee
REC reference
23/LO/0192
Date of REC Opinion
14 Apr 2023
REC opinion
Further Information Favourable Opinion