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

Sponsor
Entia Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT03923296
Collaborator
(none)
62
1
25.9
2.4

Study Details

Study Description

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 Phase
  • Device: Blood measurement and monitoring
  • Behavioral: Interviews

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

Study Type:
Observational
Actual Enrollment :
62 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.
Actual Study Start Date :
May 20, 2019
Actual Primary Completion Date :
Jul 16, 2021
Actual Study Completion Date :
Jul 16, 2021

Arms and Interventions

Arm Intervention/Treatment
HCPs

Health care professional interviews (market research)

Behavioral: Interviews
Focus group interviews

Patients or caregivers

Patients or caregivers interviews

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

Behavioral: Interviews
Focus group interviews

Outcome Measures

Primary Outcome Measures

  1. Qualitative capture of user feedback- focus groups [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Christie NHS Foundation Trust Manchester United Kingdom M20 4BX

Sponsors and Collaborators

  • Entia Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Entia Ltd
ClinicalTrials.gov Identifier:
NCT03923296
Other Study ID Numbers:
  • IRAS: 234137
First Posted:
Apr 22, 2019
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Entia Ltd

Study Results

No Results Posted as of Apr 6, 2022