ePainQ - Feasibility Study

NCT ID: NCT03638414

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-06
• Study Completion Date: 2020-03-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 - Interventional Treatment

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

Group Type: EXPERIMENTAL

ePainQ questionnaire

Intervention Type: OTHER

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

Group 2 - Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ePainQ questionnaire

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Sue Hartup

Role: CONTACT

s.hartup@nhs.net

01132068628

Other Identifiers

GS18/107321

Identifier Type: -

Identifier Source: org_study_id