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

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: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Interviews; 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.

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	30 months

Collaborators and Investigators

• Sponsor: Entia Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 20, 2019
• Primary Completion (ACTUAL): July 16, 2021
• Study Completion (ACTUAL): July 16, 2021

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 19, 2019
• First Posted (ACTUAL): April 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: blood; point of care; device; home monitoring
• Other Study ID 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