Contact information
Type
Scientific
Primary contact
Prof Nora Kearney
ORCID ID
Contact details
Cancer Care Research Centre
Department of Nursing and Midwifery
University of Stirling
Stirling
Scotland
FK9 4LA
United Kingdom
+44 (0)1786 849260
nora.kearney@stir.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Evaluation of a mobile phone-based, advanced symptom management system (ASyMS©) in the management of chemotherapy-related toxicity
Acronym
The ASyMS study
Study hypothesis
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
Approved by Fife and Forth Valley Research Ethics Committee, reference number 05/S0501/81. Approval was granted in August 2006
Study design
Randomised controlled study design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/12/2005
Overall trial end date
01/11/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
150
Participant 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
Recruitment start date
01/12/2005
Recruitment end date
01/11/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cancer Care Research Centre
Scotland
FK9 4LA
United Kingdom
Sponsor information
Organisation
University of Stirling (UK)
Sponsor details
Stirling
Scotland
FK9 4LA
United Kingdom
+44 (0)1786 473171
research@stir.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Stirling University Research Enterprise
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 Results: http://www.ncbi.nlm.nih.gov/pubmed/18953579
Publication citations
-
Results
Kearney N, McCann L, Norrie J, Taylor L, Gray P, McGee-Lennon M, Sage M, Miller M, Maguire R, Evaluation of a mobile phone-based, advanced symptom management system (ASyMS) in the management of chemotherapy-related toxicity., Support Care Cancer, 2009, 17, 4, 437-444, doi: 10.1007/s00520-008-0515-0.