None listed
Conditions
Brief summary
The purpose of the research is to investigate young and adult people’s acceptability and satisfaction with a self-management program that aims to help make it easier for people to take their oral cancer tablets and is delivered via smartphone text messages. Who is it for? You may be eligible for this study if you are between 16-75 years old, own a smartphone, and are in either active or maintenance treatment with oral chemotherapy. Study details All participants in this study will receive daily text messages, information on their chemotherapy and information on symptom management, over a 10-week period. Participants will also be asked to complete surveys at the beginning and the end of the 10 week period. This study will help us plan a follow-up study and could help future young and adult cancer patients to more accurately follow their oral cancer treatment, as prescribed by their doctors.
Interventions
In the first week of the study, participants will complete assessment measures (socio-demographic and oral cancer tablets questionnaire, Knowledge of Chemotherapy, Symptom Presence and Severity and MARS-5). They will also receive verbal and written instructions on the appropriate use of the Medication Event Monitoring System (MEMS) device from their pharmacist or one of the researchers. All of the participants will be provided with a MEMS device. The MEMS consists of a medication bottle and an electronic cap which tracks every occasion the device is opened to take the medication (with date and time). The devices will be adequately filled and labeled by the oncology hospital pharmacy at recruitment sites. Participants will be instructed to start using the device to take their first due oral chemotherapy dose after MEMS collection. Participants will start the intervention the day after they receive the MEMS. The MEMS device will be re-filled at the hospital oncology pharmacy every time a drug prescription re-fill is due. The MEMS is used in research as a medication adherence assessment tool. However, in this study the purpose of the use of MEMS is to explore participants' acceptability and satisfaction with the use of the device as part of the intervention. The intervention will be delivered via text messages (SMS) to patients’ smartphones. This will be in addition to usual cancer care and will last for 10 weeks. The automated text message system will consist of a dynamic database integrated into the Amazon Web Services cloud platform with a text-based interface that controls text messages sent to a third-party short message service (SMS). It comprises the following: a) A database of participants information including participant code (replacing name), mobile phone number, preferred notification time and frequency (i.e. daily or 2 weeks-in one week-off) for medication reminders and preferred time and frequency for delivery of information of oral chemotherapy and information of side-effects. b) An interface with a third-party short text message provider. c) Database information will be updated manually by the research team. A confidentiality agreement between the automated text message system developer and the University of South Australia will be signed prior to start the design of the solution in order to protect the security of participant’s information. The Amazon Web Services cloud is a secure platform and the security policy commits to a high level of protection on information uploaded to the cloud. This platform has been used in previous research involving text messages solutions in the health sector in Australia. The third-party short message service is “ClickSend” with head office in Perth and servers located in multiple secure data centres (geographically separated for redundancy). All data is stored securely and encrypted. Only the research team and the developer will have access to the participants’ database. The last one will have limited access to the system once the study starts, restricted to technical support when necessary. SMS Reminders: Daily SMS will be sent to participants from week 1-10 as a reminder to take their medication 15 minutes before their dose of oral chemotherapy is due. The time of SMS delivery will be tailored to each participant according to their individual medication schedule, as per information collected at enrollment and updates from participants and their medical team. The message content will be standard for all participants but the contact name/phone number for hospital contact at the end of the message will vary upon the treatment site for each participant. The content of the message will be: “Please take your cancer tablets now. If you need further support, let us know and we’ll be more than happy to help (name and phone hospital contact)” Information of oral chemotherapy: At enrollment, patients will select how often they prefer to receive oral chemotherapy information on their phones. The information’s format will consist of a short PDF document sent as a hyperlink, that is smartphone friendly and specific to the medication each patient is prescribed. The structure of the content is based on the Multinational Association for Supportive Care in Cancer Oral Agent Teaching Tool (MOATT), which has been widely used in clinical practice and research. The content will be extracted from the website www.eviq.org.au, which is frequently recommended to patients by their oncology teams in Australia. This intervention component consists of a series of 5 documents: 1) information of patient’s specific oral chemotherapy, 2) general advice, 3) safety at home, 4) oral chemotherapy side effects and 5) when to get help. Information of Symptom Management: At enrollment, patients will select the preferred frequency for delivery of side-effect management information. This practical information on how to manage, address and report the five most common oral chemotherapy-related symptoms (according to drug information brochure) will be sent in PDF format as an SMS hyperlink. This component is an Australian-adapted short version of the Symptom Management Tool Kit created by researchers at the Michigan State University, that has been used in previous investigations with cancer patients treated with oral chemotherapy. Permission to use the tool kit was obtained from Michigan State University. At the end of the study (week 10) participants will complete the following assessment measures: assessment measures (Satisfaction Survey, Knowledge of Chemotherapy, Symptom Presence and Severity and MARS-5.
Sponsors
Study design
Eligibility
Inclusion criteria
Participants in this study will be between 16 y/o and 75y/o, be in active or maintenance treatment with oral chemotherapy, own a smartphone, have access to the internet at least once a week, be willing to receive and read SMS and be able to read and speak English. The duration of treatment with oral chemotherapy and life expectancy should be of at least 3 months from the beginning of study. Change in a participant’s prognosis of life expectancy been less than 3 months during the study will not affect study participation. The participant will be able to continue with the study unless that person decides to withdraw at an earlier stage.
Exclusion criteria
Exclusion criteria will be current participation in studies aiming to improve oral chemotherapy adherence and the self-reported or suspected presence of a condition affecting cognitive functioning e.g. dementia, psychosis. Conditions affecting people’s judgement might limit the ability to understand and answer data collection questionnaires.