Clinical trial NCT02170415: Development of a Personalised Care Plan Designed to Reduce Chronic Post-Operative Pain Following Breast Surgery
Official title: Development of a Personalised Care Plan Designed to Reduce Chronic Post-Operative Pain Following Breast Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Post-surgical Pain
Neuropathic Pain
Cancer Pain
Keywords: Persistent post-surgical pain
Breast surgery
Complex intervention
Pain treatment
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Institute of Cancer Research, United Kingdom
First posted: 2014-06-23
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Numerous surveys have shown that following breast surgery, longterm pain affects around half of patients. Given that 1 in 9 women will get breast cancer and that surgery is the cornerstone of treatment, persistent pain represents a major challenge. In addition to the suffering chronic pain causes to individual patients, the investigators know that it places a substantial burden on families and carers, and that patients with pain represent an excessive demand on healthcare resources.

This research will evaluate the impact of introducing a proactive, integrated care plan for patients having breast surgery. It will assess the effect of the care plan on reducing the number of patients with pain at 3 and 12 months after their procedure.

The personalised plan involves numerous evidence based steps linked by a single unifying description aimed at controlling pain, before, during and after the procedure, in hospital and at home.

Patients at risk of developing pain will be identified prior to the procedure and randomly allocated to follow either the personalised care plan or to receive 'usual' care. In the personalised care plan group, participants will get information about chronic pain, be screened for pain and offered immediate treatment. During their procedure both the surgeon and the anaesthetist will offer treatments such as nerve numbing procedures that reduce the likelihood of experiencing pain.

After their procedure, patients will be again screened for pain and further treatment instigated. Physiotherapists and other allied health professionals such as psychologists will also be involved as appropriate. A package of care for pain will then be passed on to the patients' GP, in the form of a written pain management plan, for ongoing care which will be linked to the hospital. Patients from both groups will be followed up for a year at regular intervals.


Eligibility criteria: Inclusion Criteria:

* Women aged 18 and over with breast cancer undergoing breast surgery at the Royal Marsden Hospital. This includes mastectomy, wide local excision with axillary clearance, breast reconstruction surgery i.e Diep flap, LD flap

Exclusion Criteria:

* Previous thoracic surgery.
* Symptomatic angina pectoris.
* Renal impairment.
* Inability to read or to understand consent documentation.
* Patients undergoing the following surgery; lumpectomy, wide local excision, cosmetic procedures, any day-case breast surgery.

Primary outcomes:
measure: Difference in pain scores (as indicated by a pain severity index score) in the intervention group compared to the 'usual care' group.
timeFrame: 3 months
Secondary outcomes:
measure: The difference in levels of anxiety and depression (versus 'usual care') measured by the hospital anxiety and depression scale (HADS)
timeFrame: 3 and 12 months
measure: The difference in general health outcomes (versus 'usual care') determined by the EQ5D questionnaire
timeFrame: 3 and 12 months
measure: The difference in participant satisfaction (versus 'usual care') determined by the Global Surgical Recovery (GSR) Scale.
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal Marsden Hospital
Study officials:
affiliation: The Royal Marsden Hospital
name: JOHN E WILLIAMS, MB BS FRCA
role: PRINCIPAL_INVESTIGATOR
References: