Clinical trial NCT03923296: PERTH 2: Co-design of a Home-based Monitoring Service for Cancer Patients to Optimize Delivery of Systemic Therapy.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: point of care
home monitoring
device
blood
Lead sponsor: Entia Ltd
Sponsor class: INDUSTRY
First posted: 2019-04-22
Enrollment: 62
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Qualitative capture of user feedback- focus groups
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
References: