Condition category
Cancer
Date applied
16/11/2018
Date assigned
30/11/2018
Last edited
30/11/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Christian Subbe

ORCID ID

Contact details

Ysbyty Gwynedd
Bangor
LL57 2PW
United Kingdom
01248-384384
christian.subbe@wales.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Prospective pilot study of a smart phone application for patients undergoing treatment for cancer

Acronym

Study hypothesis

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

Ethics Board Bangor, 22/06/2018, 18/WA/0213

Study design

Interventional non-randomised feasibility study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Screening

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

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 trial start date

15/01/2018

Overall trial end date

01/05/2019

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 intervention, 50 control, 50 next of kin / friends

Participant exclusion criteria

1. On an end-of-life pathway
2. Inability to consent

Recruitment start date

01/12/2018

Recruitment end date

01/03/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ysbyty Gwynedd
Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom

Trial participating centre

Ysbyty Glan Clwyd
Rhuddlan Road
St Asaph
LL18 5UJ
United Kingdom

Sponsor information

Organisation

BCU HB

Sponsor details

Penrhosgarnedd
Bangor
LL57
United Kingdom
01248384384
christian.subbe@wales.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.wales.nhs.uk/sitesplus/861/page/41562

Funders

Funder type

Not defined

Funder name

Tenovus

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Publication intended in July 2019, after completion of the trial

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to potential commercial sensitivities.

Intention to publish date

01/07/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes