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Trial registered on ANZCTR


Registration number
ACTRN12618001987257p
Ethics application status
Submitted, not yet approved
Date submitted
30/11/2018
Date registered
12/12/2018
Date last updated
12/12/2018
Date data sharing statement initially provided
12/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Acceptability and Satisfaction with a Text Message Self-Management Program to Support Adequate Intake of Oral Cancer Tablets
Scientific title
“A Smartphone Text Message Self-Management Program to Support Adequate Adherence to Oral Chemotherapy in Adolescents and Young Adults and Adults Cancer Patients: Proof-Of-Concept”.
Secondary ID [1] 296749 0
None
Universal Trial Number (UTN)
U1111-1224-7624
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 310626 0
Non-adherence to medication 310627 0
Condition category
Condition code
Cancer 309345 309345 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 313062 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308299 0
Acceptability of the intervention. Acceptability is defined as the proportion of participants who consent to be part of the study out of the total eligible patients approached and the proportion of participants who complete the study out of the total of participants who consent. Acceptability data will be reported as the proportion of the number of participants who completed the study/number of participants who consented with confidence interval CI=95% and a margin of error (0.05). This data will be reported on three levels: high (greater than or equal to 80%), moderate (70%-79%) and low acceptability (less than 70%).
Timepoint [1] 308299 0
Week 10
Primary outcome [2] 308300 0
Satisfaction with the intervention. This will be measured via a questionnaire designed for the purposes of this study which explores participants’ satisfaction and the usability of each component of the intervention (text message reminders, information of oral chemotherapy and information of side-effects management), and the overall intervention. Satisfaction-related data will be reported as the proportion of participants who report each of the satisfaction levels: high (greater than or equal to 75% participants with questionnaire scores between 22-26 points), moderate (65%-74% participants with questionnaire scores between 17-21 points) and low (less than or equal to 64% with questionnaire scores less than 17 points), with a confidence interval CI=95% and a margin of error (0.05)
Timepoint [2] 308300 0
Week 10
Secondary outcome [1] 354571 0
No secondary outcomes
Timepoint [1] 354571 0
No timepoint

Eligibility
Key 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.

Minimum age
16 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Due to the exploratory nature of this study, sample sizes have not been calculated. We anticipate that recruitment of maximum 40 participants should suffice to gather the data needed to answer the research question. This is feasible in a 13 months period because recruitment will take place in 7 hospitals in two states and the study will also be promoted through non-governmental organizations. Preliminary meetings with key hospital investigators informed the processes outlined in this protocol, including recruitment.

Proof-of-concept will be determined by patients’ level of acceptability and satisfaction with the intervention.
Acceptability is defined as the proportion of participants who consent to be part of the study out of the total eligible patients approached and the proportion of participants who complete the study out of the total of participants who consent. Acceptability data will be reported as the proportion of the number of participants who completed the study/number of participants who consented with confidence interval CI=95% and a margin of error (0.05). This data will be reported on three levels: high (great than or equal to 80%), moderate (70%-79%) and low acceptability (less than 70%).
Satisfaction with the intervention will be measured via a questionnaire which explores participants’ satisfaction and the usability of each component of the intervention (text message reminders, information of oral chemotherapy and information of side-effects management), and the overall intervention. Satisfaction-related data will be reported as the proportion of participants who report each of the satisfaction levels: high (greater than ot equal to 75% participants with questionnaire scores between 22-26 points), moderate (65%-74% participants with questionnaire scores between 17-21 points) and low (less than or equal to 64% with questionnaire scores less than 17 points), with a confidence interval CI=95% and a margin of error (0.05)
Descriptive statistics will be used to report data gathered through data collection tools.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2019
Actual
Date of last participant enrolment
Anticipated
20/12/2019
Actual
Date of last data collection
Anticipated
6/03/2020
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 12599 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 12600 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 12601 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [4] 12602 0
Calvary North Adelaide Hospital - North Adelaide
Recruitment hospital [5] 12603 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 12604 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 24979 0
5006 - North Adelaide
Recruitment postcode(s) [2] 24980 0
5000 - Adelaide
Recruitment postcode(s) [3] 24981 0
5011 - Woodville
Recruitment postcode(s) [4] 24982 0
5042 - Bedford Park
Recruitment postcode(s) [5] 24983 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 301329 0
University
Name [1] 301329 0
University of South Australia, Cancer Research Institute
Country [1] 301329 0
Australia
Primary sponsor type
University
Name
University of South Australia, Cancer Research Institute
Address
UniSA CRI, Building HB 8-26, City West Campus,

GPO Box 2471 Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 300994 0
None
Name [1] 300994 0
Address [1] 300994 0
Country [1] 300994 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302067 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 302067 0
Ethics committee country [1] 302067 0
Australia
Date submitted for ethics approval [1] 302067 0
30/10/2018
Approval date [1] 302067 0
Ethics approval number [1] 302067 0
Ethics committee name [2] 302068 0
Calvary Health Care Adelaide Human Research Ethics Committee
Ethics committee address [2] 302068 0
Ethics committee country [2] 302068 0
Australia
Date submitted for ethics approval [2] 302068 0
09/11/2018
Approval date [2] 302068 0
Ethics approval number [2] 302068 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89014 0
Mrs Xiomara Skrabal Ross
Address 89014 0
Cancer Research Institute
University of South Australia
HB Building, HB8-25, North Terrace,
City West Campus, ADELAIDE SA 5001
Country 89014 0
Australia
Phone 89014 0
+61 8 830 21562
Fax 89014 0
Email 89014 0
xiomara.skrabal_ross@mymail.unisa.edu.au
Contact person for public queries
Name 89015 0
Xiomara Skrabal Ross
Address 89015 0
Cancer Research Institute
University of South Australia
HB Building, HB8-25, North Terrace,
City West Campus, ADELAIDE SA 5001
Country 89015 0
Australia
Phone 89015 0
+61 8 830 21562
Fax 89015 0
Email 89015 0
xiomara.skrabal_ross@mymail.unisa.edu.au
Contact person for scientific queries
Name 89016 0
Xiomara Skrabal Ross
Address 89016 0
Cancer Research Institute
University of South Australia
HB Building, HB8-25, North Terrace,
City West Campus, ADELAIDE SA 5001
Country 89016 0
Australia
Phone 89016 0
+61 8 830 21562
Fax 89016 0
Email 89016 0
xiomara.skrabal_ross@mymail.unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants identity will not be made publicly available in order to protect their safety. De-identified data will be stored for 30 years after end of study (due to sample including underage participants) and will be published in scientific journals, conferences and a Ph.D. thesis as data groups (e.g. age, oral chemotherapy drug).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDevelopment of a smartphone program to support adherence to oral chemotherapy in people with cancer.2019https://dx.doi.org/10.2147/PPA.S225175
N.B. These documents automatically identified may not have been verified by the study sponsor.