ePainQ - Feasibility Study

Breast Neoplasm Female Clinical Trial

— ePainQ  

Official title:

ePainQ - a Web-based Pain Self-management System for Patients Undergoing Surgery for Breast Cancer: Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03638414
• Other study ID #: GS18/107321
• Status: Recruiting
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: August 2018
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: Sue Hartup
• Phone: 01132068628
• Email: s.hartup[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms

Intervention

Other:
• ePainQ questionnaire
This is a questionnaire which will be given to the intervention group about their perceptions of treatment. It will be online.

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful completion of the ePainQ questionnaire	Feasibility of the ePainQ system is the primary outcome measure for the study. This will be examined in terms of: Patient uptake rates; Patient engagement with/use of the system (e.g. log ins and completed questionnaires); Patient retention rates; Representativeness of the participants (clinically and sociodemographic); Patient feedback on perceived usability via qualitative interviews; System 'running burden' for the provider	10 months from initial completion of questionnaire to feedback about experience