Clinical trial NCT03638414: ePainQ - Feasibility Study
Official title: ePainQ - a Web-based Pain Self-management System for Patients Undergoing Surgery for Breast Cancer: Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasm Female
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a feasibility study of a web-based pain self-management system aimed at providing support for acute postoperative pain and enhancing patient care. The ePainQ symptom questionnaire provides patients with immediate graded advice dependent on severity of issues reported. Information about self-managing these issues are provided via instructions in ePainQ with hyperlinks to more detailed advice on the ePainQ website. Patients log on daily postoperatively to complete the symptom questionnaire.

Women with invasive/non-invasive breast carcinoma due to be treated by surgery with curative intent will be approached to take part in this study. We will invite consecutive eligible patients, consenting as many willing patients as possible within a fixed 12 month recruitment period. There are 2 arms to the study: intervention -using ePainQ intervention \& standard care and a cohort (control) arm, which will be standard care only.

Primary aim: To test the feasibility of a web-based pain self-management system for breast cancer patients undergoing surgery Secondary aims: 1. a) Examine preliminary effectiveness of the system (impact on outcome measures, pain etc.) b) Explore the potential associations between breast density, post-surgical scarring and pain and outcomes 2. To explore staff use and perceived usefulness of ePainQ in clinical consultations.


Eligibility criteria: Inclusion Criteria:

Aged over 18 years of age at the time of diagnosis of cancer Primary operable (TNM categories: T1, T2, T3, N0, N1, M0; invasive breast cancer or non-invasive breast cancer (diagnosed on core biopsy or diagnostic incision biopsy) Ability to give informed consent Access to the internet (those without access to the internet may participate in the cohort arm) Ability to speak and write english

Exclusion Criteria:

* Male Disease unsuitable for surgery e.g. inoperable, locally recurrent or metastatic disease Previously treated invasive breast cancer There will be a restriction to people who are able to speak/read English. This is due to lack of funding for translation of study documents Pregnant women Patients without capacity to consent or those with a major psychiatric disorder No internet access (those without access to the internet may participate in the cohort arm)

Primary outcomes:
measure: Successful completion of the ePainQ questionnaire
timeFrame: 10 months from initial completion of questionnaire to feedback about experience
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
Study officials:
References: