An evaluation of an Advanced Symptom Management System to monitor and manage chemotherapy-related toxicity

ISRCTN	ISRCTN67370244
DOI	https://doi.org/10.1186/ISRCTN67370244
Secondary identifying numbers	N/A

Submission date: 12/06/2006
Registration date: 19/07/2006
Last edited: 09/05/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/study-looking-at-system-using-mobile-phones-help-people-cope-side-effects-radiotherapy-for-lung-cancer-symptoms-asyms-r

Study website

Contact information

Prof Nora Kearney
Scientific

Cancer Care Research Centre
Department of Nursing and Midwifery
University of Stirling
Stirling
Scotland
FK9 4LA
United Kingdom

Phone	+44 (0)1786 849260
Email	nora.kearney@stir.ac.uk

Study information

Study design	Randomised controlled study design
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Evaluation of a mobile phone-based, advanced symptom management system (ASyMS©) in the management of chemotherapy-related toxicity
Study acronym	The ASyMS study
Study objectives	The hypotheses of the study are: 1. The mobile phone system will provide a more accurate reflection of chemotherapy toxicity at home 2. The mobile phone system will provide a better means of monitoring potentially dangerous toxicity, with rapid access to input from the clinical site
Ethics approval(s)	Approved by Fife and Forth Valley Research Ethics Committee, reference number 05/S0501/81. Approval was granted in August 2006
Health condition(s) or problem(s) studied	Colorectal, breast and lung cancer
Intervention	This study will evaluate the effectiveness of using a mobile phone in the home, monitoring and symptom management of patients receiving chemotherapy for colorectal cancer, lung and breast cancer. Participants in the control group receive standard care and are asked to complete a paper copy of the symptom questionnaire at designated time points throughout the study.
Intervention type	Other
Primary outcome measure	Changes in chemotherapy toxicity as a result of use of the mobile phone system and supporting information technology (IT) infrastructure
Secondary outcome measures	Symptom outcomes that will be used for future statistical power calculations
Overall study start date	01/12/2005
Completion date	01/11/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	150
Key inclusion criteria	1. A diagnosis of breast, lung or colorectal cancer 2. Commencing a new course of chemotherapy treatment (defined as those patients commencing a new chemotherapy regime irrespective of stage of disease or line of treatment) 3. Receiving out-patient chemotherapy 4. Aged 18 years or over 5. Written informed consent given 6. Able to read and write English 7. Deemed by members of the clinical team as being physically and psychologically fit to participate in the study
Key exclusion criteria	1. Patients who are unable to meet the above criteria 2. Patients who do not agree to give access to their case notes
Date of first enrolment	01/12/2005
Date of final enrolment	01/11/2006

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Cancer Care Research Centre

Scotland
FK9 4LA
United Kingdom

Sponsor information

University of Stirling (UK)
University/education

Stirling
Scotland
FK9 4LA
Scotland
United Kingdom

Phone	+44 (0)1786 473171
Email	research@stir.ac.uk
Website	http://www.external.stir.ac.uk/
"ROR"	https://ror.org/045wgfr59

Funders

Funder type

University/education

Stirling University Research Enterprise

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results:	01/04/2009		Yes	No