Dose Adaptation of Capecitabine Using Mobile Phone Toxicity Monitoring (DATACAP)

This study has been completed.

Sponsor:

Collaborators:

oxBRC

Vodafone UK Foundation

Centre of Statistics and Medicine (CSM, Oxford)

Oncology Clinical Trials Office (OCTO, Oxford)

Information provided by (Responsible Party):

University of Oxford

ClinicalTrials.gov Identifier:

NCT01053104

First received: January 3, 2010

Last updated: July 24, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 3, 2010
Last Updated Date	July 24, 2012
Start Date ^ICMJE	November 2009
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 19, 2010)	Toxicities (frequency at each of grades 2, 3 and 4, over all cycles) [ Time Frame: At the end of each cycle and at occurrence ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01053104 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 19, 2010)	Number of inappropriate dose adaptations and self care advice messages generated ['inappropriate' defined by nurse overriding generated advice [ Time Frame: At occurrence ] [ Designated as safety issue: No ] Frequency of patients receiving each piece of advice from the system, including recommendations on dose and on self-treating side effects. [ Time Frame: At occurrence ] [ Designated as safety issue: No ] Obtain descriptive information on amount and duration of drug delivery (stage 2 only) Number of patients who, dose reduce stay at same dose dose increase Total dose delivery Chemotherapy duration [ Time Frame: Twice daily ] [ Designated as safety issue: No ] Obtain feedback from staff on using the system Staff recommendations for changes or improvements to the system throughout the course of the study and Semi-structured interviews [ Time Frame: weekly for staff recommendations and one semi structured interview will take place ] [ Designated as safety issue: No ] Test and refine mobile phone and server software systems Frequency of occurrence of technological faults (for example, problems caused by no phone reception) [ Time Frame: At occurrence ] [ Designated as safety issue: No ] Patient Experience EvaluationPatient experience will be evaluated as detailed in Patient Experience Evaluation [ Time Frame: At least twice during their participation in the trial but not all patients may need to be interviewed ] [ Designated as safety issue: No ] Evaluate safety outcomes Total number of grade 3/4 toxicities throughout the study period Degree of toxicity experienced Number of alerts, split by severity [ Time Frame: End of each cycle and at occurrence ] [ Designated as safety issue: Yes ] Dose intensity in mg/m2/week and toxicities as for stage 1 [ Time Frame: Once at the end of the study for each patient ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Dose Adaptation of Capecitabine Using Mobile Phone Toxicity Monitoring
Official Title ^ICMJE	Dose Adaptation of Capecitabine Using Mobile Phone Toxicity Monitoring Pilot Study of Optimal Dose Scheduling of Capecitabine for Patients With Metastatic Colorectal or Metastatic Breast Cancer
Brief Summary	To develop a system to manage side effects and adjust chemotherapy dose such that a patient can receive their personal maximum tolerated dose.
Detailed Description	Patients with metastatic colorectal or breast cancer will be recruited. Metastatic Colorectal Cancer: capecitabine alone or capecitabine + oxaliplatin for 8 3-week cycles Metastatic Breast Cancer: capecitabine alone or capecitabine + docetaxel for 8 3-week cycles. All patients will be given a mobile phone onto which they will enter any side-effects experienced prior to taking capecitabine in the morning and evening. Any grade 3 or 4 symptoms will trigger an alert to a pager held by the ward-staff for immediate attention. Thus, patients' severe side-effects will be monitored in real time and the trial will allow real-time dose reductions during cycles and dose-increases at clinics. Patient experience in the trial will also be evaluated during their participation in the trial. Patients will already be receiving the drug prior to this study and will not be administered to patients as part of this study.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Primary care clinic
Condition ^ICMJE	Metastatic Colorectal Cancer Metastatic Breast Cancer
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	capecitabine 2000mg/m2 (Colorectal) capecitabine 2000mg/m2 d 1-14, q 3 weekly and oxaliplatin 130mg/m2 d1 q 3 weekly (CAPOX) capecitabine 2500mg/m2 (Colorectal) capecitabine 2500mg/m2 d 1-14, q 3 weekly capecitabine 2000mg/m2 (Breast) capecitabine 2000mg/m2d 1-14, q 3 weekly docetaxel 75mg/m2 (Breast) capecitabine 2000mg/m2 d 1-14, q 3 weekly and docetaxel 75mg/m2 d1 q 3 weekly
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	26
Completion Date	April 2011
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Metastatic colorectal or breast cancer patients commencing treatment on one of four specified regimens For metastatic colorectal cancer: capecitabine 2000mg/m2 d 1-14, q 3 weekly and oxaliplatin 130mg/m2 d1 q 3 weekly (CAPOX) capecitabine 2500mg/m2 d 1-14, q 3 weekly For metastatic breast cancer: capecitabine 2000mg/m2d 1-14, q 3 weekly capecitabine 2000mg/m2 d 1-14, q 3 weekly and docetaxel 75mg/m2 d1 q 3 weekly Age > 18 years Fit to start at full (100%) starting dose of all drugs Able and willing to use mobile phone Reasonable renal, liver and bone marrow function Absolute neutrophil count (ANC) >1.5 x 109/L Platelet count > 100 x 109/L Total bilirubin <1.5 ULN ALT, AST < 2.5 x ULN Alkaline phosphatase < 2.5 x ULN No obvious contra indications to capecitabine or oxaliplatin or docetaxel Patients must also be able to read, write and understand English. Exclusion Criteria: Patients who live in an area of no Vodafone or Orange mobile phone network - - Patients participating in other cancer treatment trials Moderate or severe renal impairment [creatinine clearance <30ml/min (calculated according to Cockroft-Gault formula)]
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01053104
Other Study ID Numbers ^ICMJE	Mobile Datacap, OCTO/Oxford
Has Data Monitoring Committee	No
Responsible Party	University of Oxford
Study Sponsor ^ICMJE	University of Oxford
Collaborators ^ICMJE	oxBRC Vodafone UK Foundation Centre of Statistics and Medicine (CSM, Oxford) Oncology Clinical Trials Office (OCTO, Oxford)
Investigators ^ICMJE	Not Provided
Information Provided By	University of Oxford
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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