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

NCT03923296 | Completed

• 1 other identifier: IRAS: 234137
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

point of care; home monitoring; device; blood

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

HCPs

Health care professional interviews (market research)

Behavioral: Interviews

Patients or caregivers

Patients or caregivers interviews

Device: Blood measurement and monitoring; Behavioral: Interviews

Interventions

Blood measurement and monitoring DEVICE

Blood from a single fingerprick will be used to used to measure and monitor patients blood parameters.

Patients or caregivers

Interviews BEHAVIORAL

Focus group interviews

HCPs; Patients or caregivers

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Entia Ltd: lead

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 22, 2019
• Study Start: May 20, 2019
• Primary Completion: July 16, 2021
• Study Completion: July 16, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

GB (1)