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ePainQ - Feasibility Study (ePainQ)

Primary Purpose

Breast Neoplasm Female

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ePainQ questionnaire
Sponsored by
The Leeds Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasm Female

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Leeds Teaching Hospitals NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group 1 - Interventional Treatment

Group 2 - Usual care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 4, 2018
Last Updated
August 16, 2018
Sponsor
The Leeds Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03638414
Brief Title
ePainQ - Feasibility Study
Acronym
ePainQ
Official Title
ePainQ - a Web-based Pain Self-management System for Patients Undergoing Surgery for Breast Cancer: Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 6, 2018 (Actual)
Primary Completion Date
March 30, 2020 (Anticipated)
Study Completion Date
March 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - Interventional Treatment
Arm Type
Experimental
Arm Description
This group will be given the ePainQ questionnaire and an interview.
Arm Title
Group 2 - Usual care
Arm Type
No Intervention
Arm Description
This group will be receiving normal routine care without the study intervention
Intervention Type
Other
Intervention Name(s)
ePainQ questionnaire
Intervention Description
This is a questionnaire which will be given to the intervention group about their perceptions of treatment. It will be online.
Primary Outcome Measure Information:
Title
Successful completion of the ePainQ questionnaire
Description
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
Time Frame
10 months from initial completion of questionnaire to feedback about experience

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
only female patients are eligible as this is only run in the female breast clinic.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sue Hartup
Phone
01132068628
Email
s.hartup@nhs.net
Facility Information:
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

ePainQ - Feasibility Study

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