CancerNCT03923296
PERTH 2: Co-design of a Home-based Monitoring Service for Cancer Patients to Optimize Delivery of Systemic Therapy.
An observational study of Cancer, run by Entia Ltd at 1 site in United Kingdom.
Trial summary
Iterative co-design study where patients receiving systemic cancer therapy, carers and healthcare professionals involved in delivering cancer therapy, work with Entia to design a home based blood monitoring service. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Blood measurement and monitoring and Interviews
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 62 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 May 2019to 16 Jul 2021
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: * Patients currently undergoing or who have previously undergone, systemic therapy within the past 12 months. * Carers of eligible patients. * Healthcare professionals and experts employed at the study sites. This will include: * Specialist registrars, fellows, consultants, nurses * Laboratory and Information Technology experts
Who may be able to join
- Adequate english to participate in focus groups and workshops without an interpreter
- Patients of the study site who are currently undergoing systemic therapy or have previously undergone systemic therapy within the past 12 months
- Patients willing to participate in at least 60-minute and ideally 90-minute workshops at the designated study location, time and date.
- Patients capable of providing informed consent before attending the first workshop
- For carers
- Should be the primary carer nominated by a patient who fulfils the inclusion criteria, this includes parents of affected children
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- Should be willing to participate in at least a 60-minute and ideally 90-minute workshops at the designated study location, time and date.
- Carers can only participate in the study with the cancer patient he/she is caring for. The patient has to also involved in the study
- Carers need to be capable of providing informed consent before attending the first workshop
- For healthcare professionals
- All clinicians need to be current employees of the study site
- Doctors need to be employed at Specialist Registrar, Fellow or Consultant Level
- Nurses of all grades are invited to participate but ideally need to have had some involvement in the outpatient care of oncology patients
- All participants:-
- Should be willing to have the session's recorded audio, transcripts and analysed data from the focus groups/workshops shared with Entia Ltd.
- should be willing to attend multiple 60 to 90 minute workshops.
- should be willing for photos and video footage to be taken during the interview.
- Participants attending workshops later in the development process must be comfortable consenting to finger prick testing/ assessing the ease of use of the test disposable
Who cannot join
- For patients
- Does not have adequate English to participate in focus group interview without an interpreter
- Patients of the study site who are not currently undergoing systemic therapy or have previously undergone systemic therapy within the past 12 months
- Patients not willing to participate in at least 60-minute and ideally 90-minute focus group discussion at the designated study location, time and date.
- Participant not capable of providing consent or have a suitable, legally acceptable representative present to provide consent before the focus group interview.
- For carers
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- Is not the nominated primary carer of a cancer patient who fulfils the inclusion criteria, this includes parents of affected children
- Not paired with a patient that is involved in the study
- Carers not willing to participate in at least a 60-minute and ideally 90-minute focus group discussion at the designated study location, time and date.
- For healthcare professionals
- ● Doctors who are not employed at Specialist Registrar, Fellow or Consultant Level
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester, M20 4BX
About this study
Official title: PERTH 2: Co-design of a Home-based Monitoring Service for Cancer Patients, Carers and Health Care Professionals to Optimize Delivery of Systemic Therapy.
Iterative co-design study where patients receiving systemic cancer therapy, carers and healthcare professionals involved in delivering cancer therapy, work with Entia to design a home based blood monitoring service. The iterative process means that at each stage of the development process, Entia will be building on what is learnt in the previous stage.
Read the detailed description
The study will use feedback provided by patients, carers and heatlhcare professionals to inform the changes that are necessary to develop a successful, user friendly home-based blood monitoring service for cancer patients.
- Conditions
- Cancer
- Being tested
- Blood measurement and monitoring, Interviews
- Keywords
- point of care, home monitoring, device, blood
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood measurement and monitoringDevice
Blood from a single fingerprick will be used to used to measure and monitor patients blood parameters.
InterviewsBehavioural
Focus group interviews
| Study group | Role | What they receive |
|---|---|---|
| HCPs | Health care professional interviews (market research) Receives: Behavioral: Interviews | |
| Patients or caregivers | Patients or caregivers interviews Receives: Device: Blood measurement and monitoring; Behavioral: Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative capture of user feedback- focus groups
Participant feedback on the iterative designs of a future home-based monitoring service in order to arrive at a final prototype device and service design, suitable for patient, carer and healthcare professional's use.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start20 May 2019
- Primary completion16 Jul 2021
- Study completion16 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923296
- Sponsor's protocol ID
- IRAS: 234137
- Status last verified
- Mar 2022
- First submitted
- 16 Apr 2019
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERTH 2: Co-design of a Home-based Monitoring Service for Cancer Patients, Carers and Health Care Professionals to Optimize Delivery of Systemic Therapy.
- ClinicalTrials.gov ID
- NCT03923296
- Acronym / sponsor ID
- IRAS: 234137
- Conditions
- Cancer
- Keywords
- point of care, home monitoring, device, blood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Entia LtdIndustry (pharma, biotech, devices)
- Study start
- 20 May 2019 (actual)
- Primary completion
- 16 Jul 2021 (actual)
- Study completion
- 16 Jul 2021 (actual)
- First posted
- 22 Apr 2019 (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.
Iterative co-design study where patients receiving systemic cancer therapy, carers and healthcare professionals involved in delivering cancer therapy, work with Entia to design a home based blood monitoring service. The iterative process means that at each stage of the development process, Entia will be building on what is learnt in the previous stage.
Detailed description
The study will use feedback provided by patients, carers and heatlhcare professionals to inform the changes that are necessary to develop a successful, user friendly home-based blood monitoring service for cancer patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCPs | – | Behavioral: InterviewsHealth care professional interviews (market research) |
| Patients or caregivers | – | Device: Blood measurement and monitoring, Behavioral: InterviewsPatients or caregivers interviews |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Patients currently undergoing or who have previously undergone, systemic therapy within the past 12 months. * Carers of eligible patients. * Healthcare professionals and experts employed at the study sites. This will include: * Specialist registrars, fellows, consultants, nurses * Laboratory and Information Technology experts
Key inclusion criteria (18 listed)
- Adequate english to participate in focus groups and workshops without an interpreter
- Patients of the study site who are currently undergoing systemic therapy or have previously undergone systemic therapy within the past 12 months
- Patients willing to participate in at least 60-minute and ideally 90-minute workshops at the designated study location, time and date.
- Patients capable of providing informed consent before attending the first workshop
- For carers
Key exclusion criteria (11 listed)
- For patients
- Does not have adequate English to participate in focus group interview without an interpreter
- Patients of the study site who are not currently undergoing systemic therapy or have previously undergone systemic therapy within the past 12 months
- Patients not willing to participate in at least 60-minute and ideally 90-minute focus group discussion at the designated study location, time and date.
- Participant not capable of providing consent or have a suitable, legally acceptable representative present to provide consent before the focus group interview.
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 |
|---|---|---|
| Blood measurement and monitoringBlood from a single fingerprick will be used to used to measure and monitor patients blood parameters. | Device | Patients or caregivers |
| InterviewsFocus group interviews | Behavioural | HCPs, Patients or caregivers |
Primary outcome
Qualitative capture of user feedback- focus groups
Time frame: 30 months
Participant feedback on the iterative designs of a future home-based monitoring service in order to arrive at a final prototype device and service design, suitable for patient, carer and healthcare professional's use.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Entia Ltd 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 18 inclusion and 11 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: finished, as of the sponsor's last update on 6 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative capture of user feedback- focus groups (time frame: 30 months). 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 6 Apr 2022.