Cancer Clinical Trial
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.
NCT number | NCT03923296 |
Other study ID # | IRAS: 234137 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 20, 2019 |
Est. completion date | July 16, 2021 |
Verified date | March 2022 |
Source | Entia Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 62 |
Est. completion date | July 16, 2021 |
Est. primary completion date | July 16, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Christie NHS Foundation Trust | Manchester |
Lead Sponsor | Collaborator |
---|---|
Entia Ltd |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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