ePainQ - Feasibility Study

NCT03638414 | Unknown

• 1 other identifier: GS18/107321
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm Female

Outcome Measures

Primary Outcomes (1)

• 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: 1. Patient uptake rates 2. Patient engagement with/use of the system (e.g. log ins and completed questionnaires) 3. Patient retention rates 4. Representativeness of the participants (clinically and sociodemographic) 5. Patient feedback on perceived usability via qualitative interviews 6. System 'running burden' for the provider

  10 months from initial completion of questionnaire to feedback about experience

Study Arms (2)

Group 1 - Interventional Treatment

EXPERIMENTAL

This group will be given the ePainQ questionnaire and an interview.

Other: ePainQ questionnaire

Group 2 - Usual care

NO INTERVENTION

This group will be receiving normal routine care without the study intervention

Interventions

ePainQ questionnaire OTHER

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

Group 1 - Interventional Treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: only female patients are eligible as this is only run in the female breast clinic.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

Central Study Contacts

Sue Hartup

CONTACT

01132068628; s.hartup@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: August 20, 2018
• Study Start: August 6, 2018
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: August 20, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)