Dose Adaptation of Capecitabine Using Mobile Phone Toxicity Monitoring (DATACAP)
To develop a system to manage side effects and adjust chemotherapy dose such that a patient can receive their personal maximum tolerated dose.
Metastatic Colorectal Cancer
Metastatic Breast Cancer
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||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|
- 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 ]
- 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 ]
|Study Start Date:||November 2009|
|Study Completion Date:||April 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053104
|Oxford Cancer Centre, Churchill Hospital|
|Oxford, United Kingdom, OX3 7LJ|