An evaluation of an Advanced Symptom Management System to monitor and manage chemotherapy-related toxicity
ISRCTN | ISRCTN67370244 |
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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
Contact information
Prof Nora Kearney
Scientific
Scientific
Cancer Care Research Centre
Department of Nursing and Midwifery
University of Stirling
Stirling
Scotland
FK9 4LA
United Kingdom
Phone | +44 (0)1786 849260 |
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nora.kearney@stir.ac.uk |
Study information
Study design | Randomised controlled study design |
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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 |
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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
FK9 4LA
United Kingdom
Sponsor information
University of Stirling (UK)
University/education
University/education
Stirling
Scotland
FK9 4LA
Scotland
United Kingdom
Phone | +44 (0)1786 473171 |
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research@stir.ac.uk | |
Website | http://www.external.stir.ac.uk/ |
https://ror.org/045wgfr59 |
Funders
Funder type
University/education
Stirling University Research Enterprise
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | Results: | 01/04/2009 | Yes | No |