SarcomaNCT02833246
Using a Patient-Centered mHealth Intervention to Improve Adherence to Oral Anticancer Medications
A study testing SMS/MMS text messaging in people with Sarcoma and Lung, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This study is being done to determine if sending reminder text messages helps patients take their Oral Anticancer Medication (OAMs) when they are supposed to. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Lung, Solid Tumor Gastrointestinal
- What is being tested?
- SMS/MMS text messaging
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2016to 14 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient in the Sarcoma, Solid Tumor Gastrointestinal (ST GI), and Thoracic Medicine service at MSK.
- Starting a new treatment regimen that includes a single oral anticancer medication
- Patients must have a mobile phone that can send and receive SMS/MMS messages and is internet-enabled.
- Age 18 or older.
- Ability to speak and read English because we do not have the resources to translate the text messages into other languages.
Who cannot join
- Patient expresses inability or unfamiliarity with using SMS/MMS messaging on their phone and is unwilling to be trained in the use of this technology.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
This study is being done to determine if sending reminder text messages helps patients take their Oral Anticancer Medication (OAMs) when they are supposed to.
- Conditions
- Sarcoma, Lung, Solid Tumor Gastrointestinal
- Being tested
- SMS/MMS text messaging, usual care
- Keywords
- texting, Adherence to Oral Anticancer Medications, 16-810
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS/MMS text messagingOther
text messaging reminders on oral chemotherapy medication adherence
usual careOther
| Study group | Role | What they receive |
|---|---|---|
| SMS/MMS text messaging | Experimental | Patients will be able to tailor their SMS/MMS reminders with respect to when (i.e., what time of day) they wish to receive the reminders, as well as how often the messages are sent (e.g., morning and evening). Receives: Other: SMS/MMS text messaging |
| usual care | Active comparator | This includes physician and nursing assessment and intervention for any identified AEs. Of note, there is not currently standard follow-up that patients receive from nursing or physician staff while on an OAM treatment. Patients are encouraged to call their physician's office with any questions or changes in their medical status but are not called routinely by MSK staff. Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective pill count
is greater or less than the amount of OAM that the patient should have in their possession.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start28 Jun 2016
- Primary completion14 Nov 2018
- Study completion14 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Atkinson, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833246
- Sponsor's protocol ID
- 16-810
- Status last verified
- Nov 2018
- First submitted
- 12 Jul 2016
- Last updated
- 19 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Patient-Centered mHealth Intervention to Improve Adherence to Oral Anticancer Medications
- ClinicalTrials.gov ID
- NCT02833246
- Acronym / sponsor ID
- 16-810
- Conditions
- Sarcoma, Lung, Solid Tumor Gastrointestinal
- Keywords
- texting, Adherence to Oral Anticancer Medications, 16-810
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 28 Jun 2016 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to determine if sending reminder text messages helps patients take their Oral Anticancer Medication (OAMs) when they are supposed to.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS/MMS text messaging | Experimental | Other: SMS/MMS text messagingPatients will be able to tailor their SMS/MMS reminders with respect to when (i.e., what time of day) they wish to receive the reminders, as well as how often the messages are sent (e.g., morning and evening). |
| usual care | Active comparator | Other: usual careThis includes physician and nursing assessment and intervention for any identified AEs. Of note, there is not currently standard follow-up that patients receive from nursing or physician staff while on an OAM treatment. Patients are encouraged to call their physician's office with any questions or changes in their medical status but are not called routinely by MSK staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient in the Sarcoma, Solid Tumor Gastrointestinal (ST GI), and Thoracic Medicine service at MSK.
- Starting a new treatment regimen that includes a single oral anticancer medication
- Patients must have a mobile phone that can send and receive SMS/MMS messages and is internet-enabled.
- Age 18 or older.
- Ability to speak and read English because we do not have the resources to translate the text messages into other languages.
Key exclusion criteria (1 listed)
- Patient expresses inability or unfamiliarity with using SMS/MMS messaging on their phone and is unwilling to be trained in the use of this technology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS/MMS text messagingtext messaging reminders on oral chemotherapy medication adherence | Other | SMS/MMS text messaging |
| usual care | Other | usual care |
Primary outcome
objective pill count
Time frame: 1 year
is greater or less than the amount of OAM that the patient should have in their possession.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Atkinson, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS/MMS text messaging in people with Sarcoma and Lung, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective pill count (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.