ISRCTN - ISRCTN67370244: An evaluation of an Advanced Symptom Management System to monitor and manage chemotherapy-related toxicity

Plain English Summary

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

Trial website

http://www.cancercare.stir.ac.uk/projects/asyms.htm

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 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 trial start date

01/12/2005

Overall trial end date

01/11/2006

Reason abandoned (if study stopped)

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

http://www.external.stir.ac.uk/

Funders

Funder type