PERTH 2: Co-design of a Home-based Monitoring Service for Cancer Patients to Optimize Delivery of Systemic Therapy.

March 28, 2022 updated by: Entia Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

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

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
HCPs
Health care professional interviews (market research)
Behavioral: Interviews
Focus group interviews
Patients or caregivers
Patients or caregivers interviews
Behavioral: Interviews
Focus group interviews
Device: Blood measurement and monitoring
Blood from a single fingerprick will be used to used to measure and monitor patients blood parameters.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Entia Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 16, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRAS: 234137

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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