CancerNCT04701736
A Trial to Assess the Influence of a Pictorial Medication Calendar on Medication Taking Behaviour
A study testing Picture Medication Calendar in people with Cancer and Chemotherapy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Determine if an oncology pictorial medication calendar will improve patient adherence to oncology supportive care medication regimens for adult patients receiving adjuvant or neo-adjuvant chemotherapy treatment for cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Chemotherapy, Medication Adherence
- What is being tested?
- Picture Medication Calendar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to Jan 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
- Outpatients 18 years or older receiving chemotherapy treatment for neoadjuvant or adjuvant solid organ cancers,
- Able to provide consent for themselves,
- Calendar was only available in the English language, thus fluency in English was required.
Who cannot join
- Participants who did not attain a minimum of grade 8 education,
- Significant visual impairment that precluded the ability to read the picture-based medication calendar,
- Difficulty swallowing with requirement for liquid formulations of medications,
- If planned to receive multiple cycles of chemotherapy at satellite oncology location instead of main study site,
- If unable to repeat the instructions back to research personnel or a care provider had to speak on the participant's behalf, the participant was withdrawn from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Assess the Influence of a Picture-Based Antiemetic Medication Calendar on Medication-Taking Behavior in Adults Receiving Chemotherapy
Determine if an oncology pictorial medication calendar will improve patient adherence to oncology supportive care medication regimens for adult patients receiving adjuvant or neo-adjuvant chemotherapy treatment for cancer.
Read the detailed description
Primary Objective: In order to evaluate the impact of such an approach on adherence, a prospective, open-label, randomized controlled pilot trial (RCT) was carried out to determine if a picture-based medication calendar would improve patient adherence to antiemetic medication regimens for adult patients receiving chemotherapy treatment for solid organ tumor origins.
The secondary objectives were: 1) to assess medication use and self-efficacy parameters, 2) to determine patient comfort with antiemetic regimen prescribed along with chemotherapy and 3) to determine patient satisfaction with the calendar study tool.
- Conditions
- Cancer, Chemotherapy, Medication Adherence
- Being tested
- Picture Medication Calendar
- Keywords
- patient adherence, chemotherapy, pictorial aid, complex medication regimen, cancer
- Medical subject headings
- Neoplasms, Medication Adherence, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Picture Medication CalendarDevice
| Study group | Role | What they receive |
|---|---|---|
| Routine Care | No intervention | Routine care consists of an oncology pharmacist counselling the patient on supportive care medications prior to the patient getting his or her prescription dispensed. |
| Intervention | Active comparator | The intervention group will encompass the oncology pharmacist using the computer system to print a Picture Medication Calendar for the patient and use the calendar to explain supportive medications, in addition to routine care. Receives: Device: Picture Medication Calendar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence to Prescribed Antiemetics
Adherence is quantified as the number of doses taken of a prescribed agent divided by the number of doses prescribed, expressed as a percentage. Pill counts were utilized to calculate the number of missed doses or pills taken as a percentage of the total number prescribed and dispensed.
Measured: 1 year
Secondary outcomes (2)
Patient Understanding and Satisfaction Survey
The participant survey conducted at end of study was investigator-created and asked questions regarding demographics and medication taking behaviors. Questions specifically related to the calendar for those in the intervention arm were also asked. Questions regarding satisfaction with the calendar as well as complexity of medication regimen for oncologic treatment were assessed using a 5-point Likert scale.
Measured: 1 year
Medication Use and Self-Efficacy (MUSE) Scale
19 The tool measures an individual's perceived ability to understand information about prescribed medicines, and to follow instructions for use.
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 posted8 Jan 2021
- Study startJan 2017
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Waterloo, Medbuy Corporation, London Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Venita Harris, PharmD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701736
- Sponsor's protocol ID
- 107084
- Status last verified
- Dec 2019
- First submitted
- 25 Aug 2017
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Assess the Influence of a Picture-Based Antiemetic Medication Calendar on Medication-Taking Behavior in Adults Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT04701736
- Acronym / sponsor ID
- 107084
- Conditions
- Cancer, Chemotherapy, Medication Adherence
- Keywords
- patient adherence, chemotherapy, pictorial aid, complex medication regimen, cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Waterloo, Medbuy Corporation, London Health Sciences Centre
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 8 Jan 2021 (actual)
- 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.
Determine if an oncology pictorial medication calendar will improve patient adherence to oncology supportive care medication regimens for adult patients receiving adjuvant or neo-adjuvant chemotherapy treatment for cancer.
Detailed description
Primary Objective: In order to evaluate the impact of such an approach on adherence, a prospective, open-label, randomized controlled pilot trial (RCT) was carried out to determine if a picture-based medication calendar would improve patient adherence to antiemetic medication regimens for adult patients receiving chemotherapy treatment for solid organ tumor origins.
The secondary objectives were: 1) to assess medication use and self-efficacy parameters, 2) to determine patient comfort with antiemetic regimen prescribed along with chemotherapy and 3) to determine patient satisfaction with the calendar study tool.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Care | No intervention | –Routine care consists of an oncology pharmacist counselling the patient on supportive care medications prior to the patient getting his or her prescription dispensed. |
| Intervention | Active comparator | Device: Picture Medication CalendarThe intervention group will encompass the oncology pharmacist using the computer system to print a Picture Medication Calendar for the patient and use the calendar to explain supportive medications, in addition to routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatients 18 years or older receiving chemotherapy treatment for neoadjuvant or adjuvant solid organ cancers,
- Able to provide consent for themselves,
- Calendar was only available in the English language, thus fluency in English was required.
Key exclusion criteria (5 listed)
- Participants who did not attain a minimum of grade 8 education,
- Significant visual impairment that precluded the ability to read the picture-based medication calendar,
- Difficulty swallowing with requirement for liquid formulations of medications,
- If planned to receive multiple cycles of chemotherapy at satellite oncology location instead of main study site,
- If unable to repeat the instructions back to research personnel or a care provider had to speak on the participant's behalf, the participant was withdrawn from the study.
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 |
|---|---|---|
| Picture Medication Calendar | Device | Intervention |
Primary outcome
Medication Adherence to Prescribed Antiemetics
Time frame: 1 year
Adherence is quantified as the number of doses taken of a prescribed agent divided by the number of doses prescribed, expressed as a percentage. Pill counts were utilized to calculate the number of missed doses or pills taken as a percentage of the total number prescribed and dispensed.
2 secondary outcomes
Patient Understanding and Satisfaction Survey
Time frame: 1 year
Medication Use and Self-Efficacy (MUSE) Scale
Time frame: 1 year
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 8 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Venita Harris, PharmD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Picture Medication Calendar in people with Cancer and Chemotherapy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 3 inclusion and 5 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 8 Jan 2021. 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 Canada. 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?
Medication Adherence to Prescribed Antiemetics (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 8 Jan 2021.