Breast Neoplasm FemaleePainQNCT03638414
ePainQ - Feasibility Study
A study testing ePainQ questionnaire in people with Breast Neoplasm Female, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- ePainQ questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Aug 2018to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
About this study
Official title: ePainQ - a Web-based Pain Self-management System for Patients Undergoing Surgery for Breast Cancer: Feasibility Study
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
- Being tested
- ePainQ questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePainQ questionnaireOther
This is a questionnaire which will be given to the intervention group about their perceptions of treatment. It will be online.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Interventional Treatment | Experimental | This group will be given the ePainQ questionnaire and an interview. Receives: Other: ePainQ questionnaire |
| Group 2 - Usual care | No intervention | This group will be receiving normal routine care without the study intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 months from initial completion of questionnaire to feedback about experience
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start6 Aug 2018
- Primary completion30 Mar 2020 (estimated)
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638414
- Sponsor's protocol ID
- GS18/107321
- Acronym
- ePainQ
- Status last verified
- Aug 2018
- First submitted
- 4 Jun 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ePainQ - a Web-based Pain Self-management System for Patients Undergoing Surgery for Breast Cancer: Feasibility Study
- ClinicalTrials.gov ID
- NCT03638414
- Acronym / sponsor ID
- ePainQ / GS18/107321
- Conditions
- Breast Neoplasm Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 30 Mar 2020 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Interventional Treatment | Experimental | Other: ePainQ questionnaireThis group will be given the ePainQ questionnaire and an interview. |
| Group 2 - Usual care | No intervention | –This group will be receiving normal routine care without the study intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ePainQ questionnaireThis is a questionnaire which will be given to the intervention group about their perceptions of treatment. It will be online. | Other | Group 1 - Interventional Treatment |
Primary outcome
Successful completion of the ePainQ questionnaire
Time frame: 10 months from initial completion of questionnaire to feedback about experience
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePainQ questionnaire in people with Breast Neoplasm Female, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sue Hartup (01132068628, s.hartup@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful completion of the ePainQ questionnaire (time frame: 10 months from initial completion of questionnaire to feedback about experience). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.