KeepYouSafe: a bilingual Cancer Care Checklist application
| ISRCTN | ISRCTN13811906 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13811906 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/11/2018
- Registration date
- 30/11/2018
- Last edited
- 04/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Complications of cancer and its treatments are common. Many patients will experience side effects following chemotherapy, radiotherapy or immunological therapies. These lead to morbidity and mortality as well as resource utilisation in communities and hospitals. Complications of cancer and its treatments are predictable (fever, diarrhoea, skin reactions and drug specific effect). Stressed patients, family and friends might not always recognize the need to seek help.
The aim of this study is to show whether patients undergoing treatment for cancer can actively make sure that their treatment is safe by using checklists.
Who can participate?
Adults with cancer, along with one family or friend per patient
What does the study involve?
All participants will be given a smartphone application containing a checklist for common side effects of cancer treatment. They use the app for 60 days and complete questionnaires every 30 days
What are the possible benefits and risks of participating?
Participants may benefit from participating as they might feel extra security after checking for side effects and sharing these with a friend or family member.
Patients will be encouraged to contact health services if they experience side effects. Therefore, a possible risk of participating is that this could lead to over-treatment in some cases.
Where is the study run from?
Betsi Cadwaladr University Health Board, North Wales (UK)
When is the study starting and how long is it expected to run for?
January 2018 to May 2019
Who is funding the study?
iGrant from Tenovus Cancer Care (UK)
Who is the main contact?
Chris Subbe
christian.subbe@wales.nhs.uk
Contact information
Public
Ysbyty Gwynedd
Bangor
LL57 2PW
United Kingdom
| Phone | 01248-384384 |
|---|---|
| christian.subbe@wales.nhs.uk |
Study information
| Study design | Interventional non-randomised feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Prospective pilot study of a smart phone application for patients undergoing treatment for cancer |
| Study objectives | Usage of electronic checklists tailored to the needs of patients with cancer improves reliability and timelines of engagement with their multi-disciplinary team. Earlier diagnosis and treatment of common complications of cancer, chemo- and radio-therapy will lessen the impact on patient related outcome measures and resource utilization. |
| Ethics approval(s) | Ethics Board Bangor, 22/06/2018, 18/WA/0213 |
| Health condition(s) or problem(s) studied | Cancer (solid tumours or haematological) |
| Intervention | All participants will receive a smartphone application containing a checklist of common side effects of cancer. Participants will be asked to use this app for 60 days and will complete questionnaires every 30 days. |
| Intervention type | Behavioural |
| Primary outcome measure | Usage of application, assessed by number of completed checklists at 60 days from inclusion |
| Secondary outcome measures | 1. Number of appointments during the study period of 60 days, assessed by questionnaires to General Practitioners and assessment of the hospital patient administration system at 60 days from inclusion 2. Number of days in hospital during the study period of 60 days, assessed by review of patient administration system at 60 days from inclusion |
| Overall study start date | 15/01/2018 |
| Completion date | 01/05/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 intervention, 50 control, 50 next of kin / friends |
| Total final enrolment | 150 |
| Key inclusion criteria | Patients: 1. Aged 18 years or older 2. Cancer patient (solid tumour or haematological cancer) and their families 3. Resident of North Wales 4. Under the care of the North Wales Cancer Centre 5. Receiving bestsupportive care, chemotherapy, radiotherapy or immunotherapy 6. Owns and able to use smartphone 7. Provide informed consent The families or friends (one per patient) of the patients will also be invited to participate: 1. Owns and able to use a smartphone 2. Provide informed consent |
| Key exclusion criteria | 1. On an end-of-life pathway 2. Inability to consent |
| Date of first enrolment | 01/12/2018 |
| Date of final enrolment | 01/03/2019 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centres
Bangor
LL57 2PW
United Kingdom
St Asaph
LL18 5UJ
United Kingdom
Sponsor information
Hospital/treatment centre
Penrhosgarnedd
Bangor
LL57
Northern Ireland
United Kingdom
| Phone | 01248384384 |
|---|---|
| christian.subbe@wales.nhs.uk | |
| Website | http://www.wales.nhs.uk/sitesplus/861/page/41562 |
"ROR" |
https://ror.org/03awsb125 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Tenovus Cancer Care
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/07/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Publication intended in July 2019, after completion of the trial |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to potential commercial sensitivities. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 25/09/2020 | 04/06/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
04/06/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
19/12/2018: Internal review.
