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

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ClinicalTrials.gov Identifier: NCT03923296
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Entia Ltd

Brief 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. The iterative process means that at each stage of the development process, Entia will be building on what is learnt in the previous stage.

Condition or disease Intervention/treatment
Cancer Device: Blood measurement and monitoring

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
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.
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Intervention Details:
  • Device: Blood measurement and monitoring
    Blood from a single fingerprick will be used to used to measure and monitor patients blood parameters


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923296


Contacts
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Contact: Laurice Edwards, BSc 0203 020 0030 laurice@entia.co

Sponsors and Collaborators
Entia Ltd

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Responsible Party: Entia Ltd
ClinicalTrials.gov Identifier: NCT03923296     History of Changes
Other Study ID Numbers: IRAS: 234137
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Entia Ltd:
point of care
home monitoring
device
blood