REACT-CIPN: a study to assess the feasibility of a behavioural intervention for chemotherapy-induced peripheral neuropathy

REACT-CIPN Study: a feasibility randomised controlled trial with process evaluation of a co-designed intervention for chemotherapy-induced peripheral neuropathy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10025993

Enrollment

Registered

2023-06-26

Start date

2023-06-20

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer (breast and colorectal) Cancer

Interventions

The REACT-CIPN intervention comprises two components: (a) a printed booklet given to the participant before chemotherapy starts and (b) a short film which is provided during or after cycle 2 of treatm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients who are: 1. Able to give informed consent 2. Diagnosed with either colorectal or breast cancer 3. Due to receive their first neurotoxic chemotherapy treatment, and 4. At the risk of developing neuropathy (CIPN) due to chemotherapy such as Oxaliplatin, Docetaxel or Paclitaxel. 5. Can understand and communicate in English Clinicians in the chemotherapy unit or outpatient clinics who provide information about CIPN will be recruited.

Exclusion criteria

Exclusion criteria: Patients will be excluded if they: 1. Are unable to provide informed consent 2. Have received prior neurotoxic chemotherapy 3. Have pre-existing self-reported peripheral neuropathy due to other conditions e.g. diabetes or complication of previous surgery

Design outcomes

Primary

Measure	Time frame
Feasibility outcomes will be measured using a mixed methods approach. Quantitative data regarding recruitment, adherence and attrition will be collected using a study case report form and qualitative data regarding the acceptability of the study processes and intervention will be collected via telephone interviews. These will be collated at the end of the study to assess the following components of the feasibility study: 1. Willingness of participants to be randomised 2. Number of eligible patients 3. Recruitment and retention rate 4. Reasons for refusal/withdrawal 5. Estimate effect size and sample size for a future study 6. Time needed to collect and analyse data 7. Defining the main outcome measure of the full RCT 8. Descriptive analysis of patient-reported outcome measures (PROMs) data to assess the appropriateness of PROMs i.e. item and questionnaire level of missing data, floor and ceiling effects, internal consistency etc	—

Measure

Time frame

Feasibility outcomes will be measured using a mixed methods approach. Quantitative data regarding recruitment, adherence and attrition will be collected using a study case report form and qualitative data regarding the acceptability of the study processes and intervention will be collected via telephone interviews. These will be collated at the end of the study to assess the following components of the feasibility study: 1. Willingness of participants to be randomised 2. Number of eligible patients 3. Recruitment and retention rate 4. Reasons for refusal/withdrawal 5. Estimate effect size and sample size for a future study 6. Time needed to collect and analyse data 7. Defining the main outcome measure of the full RCT 8. Descriptive analysis of patient-reported outcome measures (PROMs) data to assess the appropriateness of PROMs i.e. item and questionnaire level of missing data, floor and ceiling effects, internal consistency etc

—

Secondary

Measure	Time frame
To assess the potential efficacy in adult patients who are at risk of developing chemotherapy-induced peripheral neuropathy (CIPN). CIPN outcomes are measured using the following: 1. The EORTC quality of life (EORTC QLC CIPN20) scale at baseline, week 8 and week 12 2. The Numerical Rating Scale (NRS) at baseline, week 8 and week 12 3. The EuroQol quality of Life (EQ-5D-5L) health questionnaire 4. EQ Visual Analogue Square (EQ-VAS) at baseline, week 8 and week 12 To explore potential therapeutic mechanisms of change in relation to CIPN outcomes using the following 1. Illness perception using the Brief Illness Perception Questionnaire at baseline, week 8 and week 12 2. General self-efficacy using the General Self-Efficacy Scale at baseline, week 8 and week 12	—

Measure

Time frame

To assess the potential efficacy in adult patients who are at risk of developing chemotherapy-induced peripheral neuropathy (CIPN). CIPN outcomes are measured using the following: 1. The EORTC quality of life (EORTC QLC CIPN20) scale at baseline, week 8 and week 12 2. The Numerical Rating Scale (NRS) at baseline, week 8 and week 12 3. The EuroQol quality of Life (EQ-5D-5L) health questionnaire 4. EQ Visual Analogue Square (EQ-VAS) at baseline, week 8 and week 12 To explore potential therapeutic mechanisms of change in relation to CIPN outcomes using the following 1. Illness perception using the Brief Illness Perception Questionnaire at baseline, week 8 and week 12 2. General self-efficacy using the General Self-Efficacy Scale at baseline, week 8 and week 12

—

Countries

England, United Kingdom

Contacts

Public ContactMary Tanay

mary.tanay@royalberkshire.nhs.uk+44 (0)207 848 3229

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026