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 designRandomised controlled study design
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEvaluation of a mobile phone-based, advanced symptom management system (ASyMS©) in the management of chemotherapy-related toxicity
Study acronymThe ASyMS study
Study objectivesThe 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) studiedColorectal, breast and lung cancer
InterventionThis 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 typeOther
Primary outcome measureChanges in chemotherapy toxicity as a result of use of the mobile phone system and supporting information technology (IT) infrastructure
Secondary outcome measuresSymptom outcomes that will be used for future statistical power calculations
Overall study start date01/12/2005
Completion date01/11/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants150
Key inclusion criteria1. 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 criteria1. 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 enrolment01/12/2005
Date of final enrolment01/11/2006

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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