Feasibility trial of ScarWork for post-breast surgery pain syndrome.
Research type
Research Study
Full title
A feasibility trial of ScarWork on post-breast surgery pain syndrome (PBSPS) in early stage breast cancer patients.
IRAS ID
352185
Contact name
John Hughes
Contact email
Sponsor organisation
University of West London
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
The proposed study will employ a pragmatic mixed methods randomised parallel-group exploratory design to determine the feasibility of delivering ScarWork within an NHS setting. The trial will explore the feasibility and acceptability of all aspects of a definitive clinical trial of ScarWork for post breast surgery pain syndrome. In addition the feasibility trial will provide preliminary data on effectiveness to inform the sample size calculation for a controlled clinical trial. Patients will be randomly allocated to receive either: 1)ScarWork in addition to standard care or 2) standard care alone. Participants randomised to the ScarWork group will receive up to 5 ScarWork sessions delivered by a trained ScarWork therapist. Patients will be recruited by healthcare professionals involved in their routine cancer care at UCH Macmillan Cancer Centre. Cancer patients routinely attend UCH Macmillan Cancer Centre for ongoing symptoms, including post-breast surgery pain syndrome. Should recruitment be slower than expected, we will recruit eligible participants via cancer organisations/charities/breast cancer support groups located in London/within a reasonable distance to the Royal London Hospital for Integrated Medicine (e.g. FutureDreams, Black Women Rising, Breast Cancer Support groups). With permission from the lead contact at such organisations, we will recruit via the organisations’ social media, newsletters or poster. Participants will complete baseline outcomes measures and be asked to complete follow up outcomes measures at baseline, their final treatment (maximum of 5 sessions) and 4 weeks after the end of treatment (EOT+4). At the end of treatment participants will also be invited to take part in a qualitative telephone or online (Teams) interview to explore their views on the design of the trial, and if allocated to ScarWork their views on the intervention.
REC name
London - Queen Square Research Ethics Committee
REC reference
25/LO/0319
Date of REC Opinion
9 Jun 2025
REC opinion
Further Information Favourable Opinion